A Phase 2 interventional study of Pneumococcal vaccine GSK 2189242A (LD formulation 1) and Pneumococcal vaccine GSK 2189242A (HD formulation 2) in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 1 site in Gambia. Open to participants aged 56 Days to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.
There will be two cohorts in the study: Cohort 1 (children aged 2-4 years) and Cohort 2 (infants aged 8-10 weeks), and two steps in the study, Step 1 and Step 2. Step 1 will consist in a safety evaluation of the GSK Biologicals' pneumococcal vaccine 2189242A (GSK 2189242A or 10PP vaccine). Before evaluating the two formulations of the 10PP vaccine in infants (Cohort 2), safety and reactogenicity of the highest dose formulation of this vaccine will be evaluated in children (Cohort 1). Prevnar 13™ will be used as a control. In the second step of the study, Step 2, two investigational formulations of the 10PP vaccine will be tested in infants (Cohort 2) as regards immunogenicity, reactogenicity and safety. Both formulations of the 10PP vaccine will be evaluated according to the Expanded Programme on Immunization (EPI) schedule i.e. a 2, 3, 4 months vaccination schedule, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators. The higher dose (HD) formulation of the 10PP vaccine will be also evaluated according to the 2, 4, 9 months vaccination schedule using licensed Synflorix™ vaccine as comparator. The study in infants will also assess the immune responses to routine vaccines when co-administered with the candidate pneumococcal vaccine, using licensed Synflorix™ and Prevnar 13™ vaccines as comparators.
146 studies on the registry are indexed under Streptococcal Infections; 14 are open to participants now.
This study's enrollment of 1,320 is above the median of 270 across 106 interventional studies indexed under Streptococcal Infections.
Browse Streptococcal Infections studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
Male or female between, and including,
Additional inclusion criteria for subjects in Cohort 1:
Exclusion Criteria:
Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
Additional exclusion criteria for subjects in Cohort 1:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
Biological: Prevnar13™
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1) · Biological: Tritanrix™-HepB/Hib · Biological: Polio Sabin™ · Biological: M-Vac™ · Biological: Stamaril™
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2) · Biological: Tritanrix™-HepB/Hib · Biological: Polio Sabin™ · Biological: M-Vac™ · Biological: Stamaril™
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Biological: Synflorix™ · Biological: Tritanrix™-HepB/Hib · Biological: Polio Sabin™ · Biological: M-Vac™ · Biological: Stamaril™
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Biological: Prevnar13™ · Biological: Tritanrix™-HepB/Hib · Biological: Polio Sabin™ · Biological: M-Vac™ · Biological: Stamaril™
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2) · Biological: Tritanrix™-HepB/Hib · Biological: Polio Sabin™ · Biological: M-Vac™ · Biological: Stamaril™
This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
Biological: Synflorix™ · Biological: Tritanrix™-HepB/Hib · Biological: Polio Sabin™ · Biological: M-Vac™ · Biological: Stamaril™
Intramuscular injection
Also known as: 10PP, LD Formulation
Intramuscular injection
Also known as: 10PP, HD Formulation
Intramuscular injection
Intramuscular injection
Drug pages: Diphtheria-Tetanus-Pertussis Vaccine · Hiberix
Intramuscular injection
Orally
Intramuscular injection
Intramuscular injection
Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: From Day 0 to Month 1
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges - For Cohort 1/Step 1 Subjects
Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: From Day 0 to Month 6
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 1/Step 1 Subjects
Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects
Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 1/Step 1 Subjects
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A - For Cohort 1/Step 1 Subjects
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 1/Step 1 Subjects
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects
Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.
Time frame: At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Antibody Concentrations Against Protein D (PD) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Antibody Concentrations Against Vaccine Serotypes 3 and 19A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Antibody Concentrations Against Vaccine Serotype 6A - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Antibody Concentrations Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
Time frame: At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
Time frame: At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
Time frame: At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.
Time frame: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
Time frame: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
Time frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
Time frame: Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Time frame: Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Time frame: Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
Time frame: Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Time frame: Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
Time frame: Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)
Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: From Day 0 to Month 10
Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: From Day 0 to Month 10
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Number of Subjects With Haemophilus Influenzae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Number of Subjects With Moraxella Catarrhalis in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Number of Subjects With Group A Streptococcus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)
Number of Subjects With Staphylococcus Aureus in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
Time frame: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
Time frame: At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene - Cohort 2
Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene - Cohort 2
Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant. The samples without gene detected were considered as negative for Ply (Ply negative).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed. PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix). The samples without gene detected were considered as negative for PhtD (PhtD negative).
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs - Cohort 2
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
Time frame: At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII-2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII-2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster-2+1 schedule)
Cohort 1 subjects participated in Step 1 (duration of about 6 months). Cohort 2 subjects participated in Step 2 (duration of about 10 months). Enrolment for Step 2 was conditional upon successful results of a post-vaccination safety evaluation of all children enrolled in Cohort 1 by an Independent Data Monitoring Committee.
| Milestone | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|---|---|---|
| Started | 60 | 60 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 60 | 60 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 200 | 200 | 200 | 200 | 200 | 200 |
| Completed | 0 | 0 | 191 | 190 | 195 | 191 | 191 | 194 |
| Not completed | 0 | 0 | 9 | 10 | 5 | 9 | 9 | 6 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 0 | 2 | 2 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 4 | 6 | 3 | 1 | 2 | 1 |
| Withdrew: Migrated/moved from study area | 0 | 0 | 4 | 3 | 2 | 6 | 2 | 3 |
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Participants | 10PP-HD 1d Group | Prevnar13 1d Group |
|---|---|---|
| Any Pain | 0 | 0 |
| Grade 3 Pain | 0 | 0 |
| Any Redness | 0 | 0 |
| Grade 3 Redness | 0 | 0 |
| Any Swelling | 1 | 0 |
| Grade 3 Swelling | 1 | 0 |
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Participants | 10PP-HD 1d Group | Prevnar13 1d Group |
|---|---|---|
| Any Drowsiness | 0 | 0 |
| Grade 3 Drowsiness | 0 | 0 |
| Related Drowsiness | 0 | 0 |
| Grade 3 & Related Drowsiness | 0 | 0 |
| Any Fever | 4 | 2 |
| Grade 3 Fever | 0 | 0 |
| Related Fever | 1 | 1 |
| Grade 3 & Related Fever | 0 | 0 |
| Any Irritability/Fussiness | 0 | 0 |
| Grade 3 Irritability/Fussiness | 0 | 0 |
| Related Irritability/Fussiness | 0 | 0 |
| Grade 3 & Related Irritability/Fussiness | 0 | 0 |
| Any Loss of appetite | 1 | 0 |
| Grade 3 Loss of appetite | 0 | 0 |
| Related Loss of appetite | 0 | 0 |
| Grade 3 & Related Loss of appetite | 0 | 0 |
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Participants | 10PP-HD 1d Group | Prevnar13 1d Group |
|---|---|---|
| Any unsolicited AE(s) | 13 | 7 |
| Grade 3 unsolicited AE(s) | 0 | 0 |
| Related unsolicited AE(s) | 0 | 0 |
| Grade 3 and related unsolicited AE(s) | 0 | 0 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Participants | 10PP-HD 1d Group | Prevnar 13 1d Group |
|---|---|---|
| Any SAE(s) | 0 | 0 |
| SAE(s) related to vaccination | 0 | 0 |
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group |
|---|---|---|---|
| 1 Mth post dose 3 | 154 | 137 | 145 |
| 5 Mth post dose 3 | 148 | 149 | 159 |
| 8 Mth post dose 3 | 151 | 154 | 159 |
Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| 1 Mth post dose 2 | 142 | 152 |
| 5 Mth post dose 2 | 146 | 160 |
| 3 Mth post dose 3 | 165 | 162 |
Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Participants | 10PP-HD 1d Group | Prevnar 13 1d Group |
|---|---|---|
| ALT - Status: Unknown | 0 | 0 |
| ALT - Status: Below | 0 | 0 |
| ALT - Status: Within | 60 | 57 |
| ALT - Status: Above | 0 | 3 |
| CREA - Status: Unknown | 0 | 0 |
| CREA - Status: Below | 0 | 0 |
| CREA - Status: Within | 60 | 60 |
| CREA - Status: Above | 0 | 0 |
| Hgb - Status: Unknown | 0 | 0 |
| Hgb - Status: Below | 2 | 2 |
| Hgb - Status: Within | 57 | 56 |
| Hgb - Status: Above | 1 | 2 |
| Platelets - Status: Unknown | 0 | 0 |
| Platelets - Status: Below | 0 | 0 |
| Platelets - Status: Within | 59 | 60 |
| Platelets - Status: Above | 1 | 0 |
| WBC - Status: Unknown | 0 | 0 |
| WBC - Status: Below | 0 | 0 |
| WBC - Status: Within | 60 | 60 |
| WBC - Status: Above | 0 | 0 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Participants | 10PP-HD 1d Group | Prevnar 13 1d Group |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) - For Step 1/Cohort 1 Subjects | 0 | 0 |
Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| LU/mL | 10PP-HD 1d Group | Prevnar 13 1d Group |
|---|---|---|
| Anti-Ply | 22794.9 (17570.1 to 29573.3) | 8510.3 (6668.5 to 10860.8) |
| Anti-PhtD | 31326.3 (26293.9 to 37321.8) | 16810.0 (13516.3 to 20906.4) |
Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| LU/mL | 10PP-HD 1d Group | Prevnar 13 1d Group |
|---|---|---|
| Antibody Concentrations Against Protein D (PD) - For Cohort 1/Step 1 Subjects | 137.5 (108.4 to 174.4) | 65.1 (58.2 to 72.8) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| µg/mL | 10PP-HD 1d Group | Prevnar 13 1d Group |
|---|---|---|
| Anti-1 antibodies | 1.71 (1.33 to 2.22) | 3.12 (2.44 to 4.01) |
| Anti-4 antibodies | 4.80 (3.75 to 6.14) | 4.17 (3.33 to 5.21) |
| Anti-5 antibodies | 1.17 (0.88 to 1.55) | 1.47 (1.08 to 1.99) |
| Anti-6B antibodies | 0.50 (0.34 to 0.73) | 1.57 (0.98 to 2.51) |
| Anti-7F antibodies | 2.44 (1.99 to 2.98) | 6.11 (4.44 to 8.41) |
| Anti-9V antibodies | 0.89 (0.71 to 1.12) | 2.41 (1.87 to 3.26) |
| Anti-14 antibodies | 1.88 (1.39 to 2.53) | 3.77 (2.61 to 5.43) |
| Anti-18C antibodies | 7.58 (5.43 to 10.57) | 4.82 (3.46 to 6.71) |
| Anti-19F antibodies | 7.82 (5.84 to 10.46) | 5.95 (4.48 to 7.90) |
| Anti-23F antibodies | 0.31 (0.21 to 0.46) | 1.11 (0.74 to 1.67) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| µg/mL | 10PP-HD 1d Group | Prevnar 13 1d Group |
|---|---|---|
| Anti-3 antibodies | 0.25 (0.14 to 0.46) | 2.35 (1.77 to 3.12) |
| Anti-6A antibodies | 0.18 (0.12 to 0.27) | 1.36 (0.96 to 1.93) |
| Anti-19A antibodies | 1.38 (0.91 to 2.10) | 5.51 (4.02 to 7.55) |
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
No measurements were reported for this outcome.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Titers | 10PP-HD 1d | Prevnar 13 1d Group |
|---|---|---|
| OPSONO-1 | 17.2 (11.2 to 26.4) | 112.8 (71.9 to 177.0) |
| OPSONO-4 | 2818.9 (2009.7 to 3953.8) | 4162.3 (3123.9 to 5545.9) |
| OPSONO-5 | 9.0 (6.4 to 12.7) | 89.8 (55.8 to 144.5) |
| OPSONO-6B | 345.3 (171.4 to 695.5) | 5082.5 (3700.2 to 6981.2) |
| OPSONO-7F | 6214.0 (5217.1 to 7401.4) | 17781.0 (14034.2 to 22528.0) |
| OPSONO-9V | 2880.8 (2264.8 to 3664.5) | 12687.8 (9188.2 to 17520.2) |
| OPSONO-14 | 1116.1 (715.5 to 1741.0) | 5985.9 (4313.1 to 8307.4) |
| OPSONO-18C | 3955.4 (3027.7 to 5167.2) | 2799.8 (1931.1 to 4059.2) |
| OPSONO-19F | 862.9 (529.2 to 1407.0) | 452.8 (276.2 to 742.2) |
| OPSONO-23F | 2756.7 (1638.0 to 4639.5) | 12652.4 (8076.0 to 19822.2) |
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Titers | 10PP-HD 1d | Prevnar 13 1d Group |
|---|---|---|
| OPSONO-3 | 10.1 (6.5 to 15.8) | 152.5 (120.4 to 193.2) |
| OPSONO-6A | 212.7 (110.4 to 410.0) | 8488.8 (5984.2 to 12041.8) |
| OPSONO-19A | 461.7 (277.2 to 769.0) | 970.3 (701.0 to 1342.9) |
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.
No measurements were reported for this outcome.
Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.
| Titers | 10PP-HD 1d | Prevnar 13 1d Group |
|---|---|---|
| Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies - For Cohort 1/Step 1 Subjects | 682.3 (562.8 to 827.3) | 534.0 (439.4 to 648.9) |
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
| EL.U/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Anti-Ply 1 Mth post dose 3 | 13968.86 (12612.27 to 15471.36) | 16771.16 (15267.84 to 18422.51) | 451.32 (398.68 to 510.91) | 419.47 (377.26 to 466.40) |
| Anti-Ply 5 Mth post dose 3 | 11268.35 (9870.36 to 12864.36) | 10817.78 (9528.87 to 12281.04) | 744.86 (631.27 to 878.89) | 637.49 (539.55 to 753.22) |
| Anti-Ply 8 Mth post dose 3 | 10512.39 (9249.03 to 11948.33) | 10299.57 (9137.48 to 11609.44) | 999.39 (861.41 to 1159.49) | 884.83 (748.83 to 1045.54) |
| Anti-PhtD 1 Mth post dose 3 | 2584.28 (2292.67 to 2912.98) | 2188.28 (1934.94 to 2474.80) | 334.18 (292.90 to 381.28) | 486.01 (419.64 to 562.87) |
| Anti-PhtD 5 Mth post dose 3 | 2242.06 (1971.08 to 2550.29) | 1498.86 (1311.05 to 1713.57) | 936.83 (780.23 to 1124.86) | 1419.77 (1196.01 to 1685.40) |
| Anti-PhtD 8 Mth post dose 3 | 2608.78 (2318.09 to 2935.92) | 2078.35 (1861.91 to 2319.95) | 1667.91 (1432.09 to 1942.55) | 2380.09 (2118.18 to 2674.39) |
Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
| EL.U/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Anti-Ply 1 Mth post dose 2 | 11491.54 (10168.10 to 12987.23) | 488.79 (427.38 to 559.01) |
| Anti-Ply 5 Mth post dose 2 | 7453.65 (6460.70 to 8599.21) | 807.67 (676.20 to 964.70) |
| Anti-Ply 3 Mth post dose 3 | 17933.07 (15867.00 to 20268.17) | 1114.25 (945.08 to 1313.71) |
| Anti-PhtD 1 Mth post dose 2 | 1264.57 (1103.87 to 1448.66) | 368.62 (319.88 to 424.79) |
| Anti-PhtD 5 Mth post dose 2 | 1448.08 (1253.08 to 1673.41) | 1036.53 (853.80 to 1258.36) |
| Anti-PhtD 3 Mth post dose 3 | 3250.91 (2956.18 to 3575.02) | 1654.79 (1415.54 to 1934.47) |
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
| EL.U/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Anti-PD 1 Mth post dose 3 | 1922.8 (1739.3 to 2125.6) | 1833.8 (1628.5 to 2065.0) | 1990.2 (1765.7 to 2243.3) | 84.8 (76.4 to 94.1) |
| Anti-PD 5 Mth post dose 3 | 559.2 (496.8 to 629.6) | 499.2 (439.9 to 566.5) | 609.9 (537.0 to 692.8) | 83.1 (74.9 to 92.2) |
| Anti-PD 8 Mth post dose 3 | 324.3 (282.2 to 372.7) | 288.2 (248.5 to 334.2) | 344.2 (300.6 to 394.2) | 69.2 (63.6 to 75.3) |
Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
| EL.U/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Anti-PD 1 Mth post dose 2 | 990.9 (869.3 to 1129.5) | 1126.7 (999.4 to 1270.2) |
| Anti-PD 5 Mth post dose 2 | 281.3 (247.5 to 319.7) | 313.0 (276.2 to 354.7) |
| Anti-PD 3 Mth post dose 3 | 534.8 (468.9 to 610.0) | 664.9 (580.1 to 762.2) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
| µg/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Anti-1 1 Mth post dose 3 | 3.58 (3.17 to 4.03) | 3.20 (2.82 to 3.63) | 3.38 (2.98 to 3.83) | 5.51 (4.92 to 6.17) |
| Anti-1 5 Mth post dose 3 | 0.67 (0.59 to 0.76) | 0.55 (0.49 to 0.63) | 0.62 (0.55 to 0.71) | 1.16 (1.05 to 1.29) |
| Anti-1 8 Mth post dose 3 | 0.40 (0.35 to 0.45) | 0.35 (0.31 to 0.40) | 0.40 (0.35 to 0.46) | 0.83 (0.73 to 0.93) |
| Anti-4 1 Mth post dose 3 | 3.89 (3.43 to 4.41) | 3.15 (2.75 to 3.60) | 3.75 (3.29 to 4.28) | 6.25 (5.63 to 6.93) |
| Anti-4 5 Mth post dose 3 | 1.19 (1.06 to 1.34) | 1.04 (0.93 to 1.16) | 1.14 (1.00 to 1.29) | 1.06 (0.94 to 1.19) |
| Anti-4 8 Mth post dose 3 | 0.70 (0.62 to 0.79) | 0.59 (0.52 to 0.68) | 0.66 (0.58 to 0.76) | 0.54 (0.48 to 0.61) |
| Anti-5 1 Mth post dose 3 | 5.17 (4.54 to 5.88) | 4.83 (4.21 to 5.54) | 5.30 (4.66 to 6.02) | 7.02 (6.14 to 8.02) |
| Anti-5 5 Mth post dose 3 | 1.37 (1.21 to 1.55) | 1.25 (1.10 to 1.43) | 1.33 (1.17 to 1.51) | 1.79 (1.59 to 2.02) |
| Anti-5 8 Mth post dose 3 | 0.73 (0.65 to 0.83) | 0.68 (0.59 to 0.79) | 0.69 (0.60 to 0.79) | 1.12 (0.99 to 1.27) |
| Anti-6B 1 Mth post dose 3 | 0.91 (0.74 to 1.12) | 0.69 (0.56 to 0.86) | 1.00 (0.80 to 1.25) | 1.35 (1.11 to 1.65) |
| Anti-6B 5 Mth post dose 3 | 1.10 (0.94 to 1.29) | 0.86 (0.73 to 1.01) | 1.24 (1.06 to 1.44) | 0.38 (0.33 to 0.44) |
| Anti-6B 8 Mth post dose 3 | 0.87 (0.75 to 1.00) | 0.73 (0.62 to 0.86) | 0.96 (0.83 to 1.11) | 0.29 (0.26 to 0.34) |
| Anti-7F 1 Mth post dose 3 | 4.63 (4.10 to 5.22) | 4.10 (3.62 to 4.63) | 4.29 (3.77 to 4.88) | 5.53 (4.96 to 6.17) |
| Anti-7F 5 Mth post dose 3 | 2.24 (2.01 to 2.50) | 1.84 (1.63 to 2.08) | 2.19 (1.95 to 2.47) | 2.21 (1.99 to 2.45) |
| Anti-7F 8 Mth post dose 3 | 1.54 (1.38 to 1.72) | 1.31 (1.15 to 1.50) | 1.57 (1.39 to 1.78) | 1.65 (1.49 to 1.82) |
| Anti-9V 1 Mth post dose 3 | 3.23 (2.83 to 3.68) | 3.25 (2.83 to 3.72) | 3.26 (2.82 to 3.78) | 4.02 (3.45 to 4.69) |
| Anti-9V 5 Mth post dose 3 | 1.35 (1.20 to 1.53) | 1.15 (1.02 to 1.30) | 1.33 (1.17 to 1.52) | 0.83 (0.72 to 0.95) |
| Anti-9V 8 Mth post dose 3 | 1.09 (0.95 to 1.25) | 0.87 (0.77 to 1.00) | 1.08 (0.95 to 1.23) | 0.63 (0.55 to 0.73) |
| Anti-14 1 Mth post dose 3 | 4.36 (3.70 to 5.13) | 4.11 (3.49 to 4.85) | 4.15 (3.52 to 4.89) | 4.66 (3.93 to 5.52) |
| Anti-14 5 Mth post dose 3 | 2.15 (1.84 to 2.50) | 1.86 (1.56 to 2.22) | 2.13 (1.77 to 2.56) | 3.43 (2.89 to 4.06) |
| Anti-14 8 Mth post dose 3 | 1.38 (1.18 to 1.61) | 1.37 (1.15 to 1.63) | 1.42 (1.18 to 1.71) | 2.47 (2.10 to 2.92) |
| Anti-18C 1 Mth post dose 3 | 15.88 (13.80 to 18.26) | 14.84 (12.88 to 17.09) | 15.66 (13.52 to 18.14) | 5.78 (5.03 to 6.64) |
| Anti-18C 5 Mth post dose 3 | 4.09 (3.54 to 4.71) | 3.52 (3.06 to 4.05) | 4.17 (3.60 to 4.83) | 0.95 (0.84 to 1.06) |
| Anti-18C 8 Mth post dose 3 | 2.18 (1.90 to 2.51) | 1.82 (1.58 to 2.10) | 2.24 (1.95 to 2.58) | 0.66 (0.58 to 0.75) |
| Anti-19F 1 Mth post dose 3 | 9.47 (8.08 to 11.09) | 9.36 (8.04 to 10.91) | 10.04 (8.54 to 11.80) | 5.99 (5.40 to 6.64) |
| Anti-19F 5 Mth post dose 3 | 2.65 (2.29 to 3.07) | 2.34 (2.03 to 2.71) | 3.11 (2.67 to 3.62) | 0.96 (0.83 to 1.11) |
| Anti-19F 8 Mth post dose 3 | 1.65 (1.40 to 1.93) | 1.45 (1.22 to 1.72) | 1.99 (1.68 to 2.35) | 0.55 (0.46 to 0.66) |
| Anti-23F 1 Mth post dose 3 | 1.18 (0.98 to 1.42) | 1.14 (0.95 to 1.38) | 1.22 (0.99 to 1.51) | 2.92 (2.47 to 3.44) |
| Anti-23F 5 Mth post dose 3 | 0.78 (0.66 to 0.93) | 0.77 (0.66 to 0.89) | 0.90 (0.77 to 1.06) | 0.47 (0.40 to 0.57) |
| Anti-23F 8 Mth post dose 3 | 0.62 (0.53 to 0.73) | 0.59 (0.49 to 0.70) | 0.68 (0.58 to 0.79) | 0.39 (0.31 to 0.48) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
| µg/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Anti-1 1 Mth post dose 2 | 2.52 (2.22 to 2.86) | 2.41 (2.13 to 2.72) |
| Anti-1 5 Mth post dose 2 | 0.44 (0.39 to 0.49) | 0.42 (0.37 to 0.48) |
| Anti-1 3 Mth post dose 3 | 1.65 (1.43 to 1.90) | 1.61 (1.41 to 1.83) |
| Anti-4 1 Mth post dose 2 | 2.79 (2.42 to 3.22) | 2.67 (2.30 to 3.09) |
| Anti-4 5 Mth post dose 2 | 0.79 (0.70 to 0.89) | 0.76 (0.67 to 0.86) |
| Anti-4 3 Mth post dose 3 | 2.15 (1.91 to 2.42) | 1.92 (1.71 to 2.16) |
| Anti-5 1 Mth post dose 2 | 3.74 (3.29 to 4.26) | 3.40 (2.96 to 3.91) |
| Anti-5 5 Mth post dose 2 | 1.07 (0.95 to 1.21) | 0.92 (0.81 to 1.04) |
| Anti-5 3 Mth post dose 3 | 2.86 (2.53 to 3.23) | 2.34 (2.04 to 2.69) |
| Anti-6B 1 Mth post dose 2 | 0.51 (0.40 to 0.64) | 0.51 (0.41 to 0.64) |
| Anti-6B 5 Mth post dose 2 | 0.63 (0.53 to 0.75) | 0.67 (0.58 to 0.79) |
| Anti-6B 3 Mth post dose 3 | 1.35 (1.17 to 1.56) | 1.39 (1.21 to 1.61) |
| Anti-7F 1 Mth post dose 2 | 3.29 (2.95 to 3.67) | 3.06 (2.68 to 3.49) |
| Anti-7F 5 Mth post dose 2 | 1.47 (1.30 to 1.66) | 1.48 (1.30 to 1.68) |
| Anti-7F 3 Mth post dose 3 | 3.36 (3.00 to 3.77) | 3.40 (3.04 to 3.81) |
| Anti-9V 1 Mth post dose 2 | 1.85 (1.60 to 2.14) | 1.97 (1.72 to 2.26) |
| Anti-9V 5 Mth post dose 2 | 0.85 (0.75 to 0.95) | 0.81 (0.72 to 0.91) |
| Anti-9V 3 Mth post dose 3 | 2.86 (2.54 to 3.23) | 2.67 (2.32 to 3.06) |
| Anti-14 1 Mth post dose 2 | 2.39 (2.01 to 2.85) | 2.29 (1.92 to 2.72) |
| Anti-14 5 Mth post dose 2 | 0.85 (0.70 to 1.03) | 0.89 (0.75 to 1.06) |
| Anti-14 3 Mth post dose 3 | 2.40 (2.07 to 2.79) | 2.42 (2.09 to 2.80) |
| Anti-18C 1 Mth post dose 2 | 11.33 (9.39 to 13.68) | 10.88 (8.98 to 13.18) |
| Anti-18C 5 Mth post dose 2 | 3.00 (2.54 to 3.53) | 3.18 (2.71 to 3.74) |
| Anti-18C 3 Mth post dose 3 | 18.38 (15.94 to 21.19) | 16.24 (14.11 to 18.69) |
| Anti-19F 1 Mth post dose 2 | 7.33 (6.17 to 8.71) | 7.85 (6.61 to 9.32) |
| Anti-19F 5 Mth post dose 2 | 2.38 (2.07 to 2.74) | 2.48 (2.12 to 2.90) |
| Anti-19F 3 Mth post dose 3 | 5.99 (5.13 to 7.01) | 6.27 (5.36 to 7.32) |
| Anti-23F 1 Mth post dose 2 | 0.63 (0.51 to 0.78) | 0.67 (0.53 to 0.84) |
| Anti-23F 5 Mth post dose 2 | 0.44 (0.37 to 0.52) | 0.46 (0.39 to 0.55) |
| Anti-23F 3 Mth post dose 3 | 1.46 (1.24 to 1.72) | 1.50 (1.27 to 1.76) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
| µg/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Anti-3 1 Mth post dose 3 | 0.05 (0.04 to 0.06) | 0.05 (0.04 to 0.05) | 0.05 (0.04 to 0.06) | 4.52 (4.15 to 4.92) |
| Anti-3 5 Mth post dose 3 | 0.06 (0.05 to 0.07) | 0.06 (0.05 to 0.08) | 0.07 (0.06 to 0.09) | 0.60 (0.52 to 0.68) |
| Anti-3 8 Mth post dose 3 | 0.08 (0.07 to 0.11) | 0.09 (0.07 to 0.12) | 0.09 (0.07 to 0.11) | 0.32 (0.27 to 0.38) |
| Anti-19A 1 Mth post dose 3 | 0.24 (0.20 to 0.29) | 0.20 (0.17 to 0.24) | 0.23 (0.19 to 0.27) | 5.27 (4.41 to 6.30) |
| Anti-19A 5 Mth post dose 3 | 0.21 (0.17 to 0.25) | 0.17 (0.14 to 0.21) | 0.24 (0.20 to 0.30) | 0.91 (0.76 to 1.08) |
| Anti-19A 8 Mth post dose 3 | 0.24 (0.19 to 0.29) | 0.21 (0.17 to 0.27) | 0.27 (0.22 to 0.34) | 0.64 (0.52 to 0.79) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
| µg/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Anti-3 1 Mth post dose 2 | 0.04 (0.04 to 0.05) | 0.05 (0.04 to 0.06) |
| Anti-3 5 Mth post dose 2 | 0.06 (0.05 to 0.07) | 0.07 (0.05 to 0.09) |
| Anti-3 3 Mth post dose 3 | 0.07 (0.06 to 0.09) | 0.08 (0.06 to 0.10) |
| Anti-19A 1 Mth post dose 2 | 0.24 (0.20 to 0.29) | 0.25 (0.20 to 0.30) |
| Anti-19A 5 Mth post dose 2 | 0.18 (0.15 to 0.22) | 0.19 (0.15 to 0.24) |
| Anti-19A 3 Mth post dose 3 | 0.56 (0.43 to 0.71) | 0.64 (0.50 to 0.81) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.
| µg/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Anti-6A 1Mth post dose 3 | 0.13 (0.11 to 0.16) | 0.13 (0.11 to 0.15) | 0.13 (0.11 to 0.15) | 3.01 (2.60 to 3.48) |
| Anti-6A 5 Mth post dose 3 | 0.17 (0.14 to 0.20) | 0.15 (0.13 to 0.18) | 0.22 (0.18 to 0.27) | 1.0 (0.89 to 1.13) |
| Anti-6A 8 Mth post dose 3 | 0.16 (0.14 to 0.19) | 0.15 (0.13 to 0.18) | 0.18 (0.15 to 0.22) | 0.59 (0.51 to 0.68) |
Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.
| µg/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Anti-6A 1 Mth post dose 2 | 0.11 (0.09 to 0.12) | 0.11 (0.09 to 0.13) |
| Anti-6A 5 Mth post-dose 2 | 0.10 (0.09 to 0.12) | 0.12 (0.10 to 0.14) |
| Anti-6A 3 Mth post dose 3 | 0.14 (0.12 to 0.16) | 0.15 (0.12 to 0.17) |
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
No measurements were reported for this outcome.
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
No measurements were reported for this outcome.
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Titers | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| OPSONO-1 1 Mth post dose 3 | 136.3 (98.8 to 188.0) | 62.7 (42.8 to 91.9) | 109.9 (79.2 to 152.6) | 161.4 (116.5 to 223.8) |
| OPSONO-1 5 Mth post dose 3 | 14.1 (9.9 to 20.0) | 10.1 (7.4 to 13.8) | 11.0 (7.9 to 15.3) | 14.3 (9.9 to 20.4) |
| OPSONO-1 8 Mth post dose 3 | 10.0 (7.3 to 13.6) | 8.4 (6.4 to 11.0) | 9.3 (6.9 to 12.5) | 12.5 (8.8 to 17.6) |
| OPSONO-4 1 Mth post dose 3 | 835.0 (657.1 to 1061.0) | 784.0 (633.1 to 970.8) | 715.6 (586.5 to 873.2) | 1022.7 (839.6 to 1245.7) |
| OPSONO-4 5 Mth post dose 3 | 86.0 (58.5 to 126.4) | 48.2 (31.5 to 73.7) | 54.7 (37.2 to 80.4) | 62.8 (40.0 to 98.4) |
| OPSONO-4 8 Mth post dose 3 | 48.2 (31.0 to 74.9) | 34.3 (21.8 to 53.9) | 41.7 (27.4 to 63.7) | 41.8 (25.9 to 67.5) |
| OPSONO-5 1 Mth post dose 3 | 97.9 (75.5 to 127.0) | 51.4 (37.8 to 70.1) | 76.7 (58.5 to 100.6) | 91.5 (69.7 to 120.2) |
| OPSONO-5 5 Mth post dose 3 | 19.7 (14.9 to 26.1) | 13.1 (10.0 to 17.3) | 16.2 (12.1 to 21.5) | 17.4 (13.2 to 23.0) |
| OPSONO-5 8 Mth post dose 3 | 9.4 (7.4 to 11.9) | 8.3 (6.5 to 10.5) | 11.2 (8.7 to 14.2) | 10.8 (8.5 to 13.6) |
| OPSONO-6B 1 Mth post dose 3 | 827.6 (601.4 to 1138.9) | 432.8 (293.1 to 638.8) | 814.6 (594.1 to 1116.9) | 1317.6 (937.1 to 1852.6) |
| OPSONO-6B 5 Mth post dose 3 | 242.4 (158.9 to 369.9) | 251.3 (169.1 to 373.4) | 324.0 (227.2 to 461.9) | 90.9 (53.3 to 155.0) |
| OPSONO-6B 8 Mth post dose 3 | 146.9 (95.9 to 225.1) | 126.0 (80.4 to 197.4) | 233.1 (160.7 to 338.1) | 73.7 (43.3 to 125.4) |
| OPSONO-7F 1 Mth post dose 3 | 3755.3 (3060.5 to 4607.9) | 2993.3 (2440.1 to 3672.0) | 3767.9 (2981.2 to 4762.1) | 7241.0 (5923.2 to 8852.1) |
| OPSONO-7F 5 Mth post dose 3 | 2072.1 (1634.8 to 2626.3) | 1850.6 (1454.8 to 2354.1) | 1710.3 (1329.7 to 2199.9) | 3652.1 (2878.1 to 4634.2) |
| OPSONO-7F 8 Mth post dose 3 | 2001.5 (1629.3 to 2458.7) | 2313.0 (1851.4 to 2889.8) | 2291.2 (1903.9 to 2757.3) | 3054.1 (2502.7 to 3727.0) |
| OPSONO-9V 1 Mth post dose 3 | 909.2 (722.3 to 1144.5) | 1113.1 (888.0 to 1395.3) | 1044.6 (788.6 to 1383.6) | 878.3 (647.7 to 1191.0) |
| OPSONO-9V 5 Mth post dose 3 | 360.3 (253.2 to 512.7) | 449.2 (347.2 to 581.3) | 320.1 (236.2 to 433.6) | 342.8 (240.3 to 489.0) |
| OPSONO-9V 8 Mth post dose 3 | 330.6 (230.2 to 474.9) | 436.7 (322.5 to 591.4) | 277.0 (196.1 to 391.4) | 308.6 (216.6 to 439.7) |
| OPSONO-14 1 Mth post dose 3 | 1176.2 (823.1 to 1680.9) | 1169.8 (845.3 to 1618.9) | 1139.9 (773.2 to 1680.4) | 2504.7 (1665.7 to 3766.3) |
| OPSONO-14 5 Mth post dose 3 | 188.9 (129.7 to 275.0) | 181.3 (125.6 to 261.5) | 233.4 (160.2 to 340.1) | 499.3 (350.5 to 711.1) |
| OPSONO-14 8 Mth post dose 3 | 152.9 (103.0 to 227.1) | 186.9 (130.5 to 267.6) | 223.1 (159.0 to 313.2) | 371.0 (257.6 to 534.2) |
| OPSONO-18C 1 Mth post dose 3 | 666.2 (542.9 to 817.6) | 532.0 (413.8 to 683.9) | 623.6 (493.1 to 788.6) | 277.7 (209.9 to 367.5) |
| OPSONO-18C 5 Mth post dose 3 | 39.8 (29.4 to 54.0) | 32.0 (22.9 to 44.6) | 44.1 (32.7 to 59.5) | 9.1 (7.0 to 11.8) |
| OPSONO-18C 8 Mth post dose 3 | 13.6 (10.2 to 18.1) | 11.7 (9.0 to 15.1) | 16.9 (12.8 to 22.4) | 6.5 (5.0 to 8.3) |
| OPSONO-19F 1 Mth post dose 3 | 420.3 (307.6 to 574.2) | 340.6 (242.7 to 478.0) | 518.3 (389.1 to 690.4) | 84.8 (66.1 to 108.9) |
| OPSONO-19F 5 Mth post dose 3 | 47.2 (35.3 to 62.9) | 30.7 (22.8 to 41.4) | 66.9 (49.3 to 90.9) | 7.2 (5.4 to 9.5) |
| OPSONO-19F 8 Mth post dose 3 | 22.0 (16.3 to 29.6) | 20.3 (14.6 to 28.5) | 32.5 (23.6 to 44.7) | 7.0 (5.4 to 9.2) |
| OPSONO-23F 1 Mth post dose 3 | 1421.3 (976.4 to 2068.9) | 965.1 (622.7 to 1495.8) | 1030.2 (693.0 to 1531.4) | 2821.9 (1913.1 to 4162.3) |
| OPSONO-23F 5 Mth post dose 3 | 307.4 (183.0 to 516.3) | 387.1 (234.4 to 639.1) | 239.5 (140.2 to 409.1) | 638.6 (369.2 to 1104.6) |
| OPSONO-23F 8 Mth post dose 3 | 306.2 (172.3 to 543.9) | 385.9 (221.1 to 673.5) | 410.8 (246.7 to 684.2) | 650.4 (367.1 to 1152.3) |
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Titers | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| OPSONO-1 1 Mth post dose 2 | 67.3 (46.5 to 97.4) | 58.0 (40.4 to 83.4) |
| OPSONO-1 5 Mth post dose 2 | 7.7 (6.0 to 9.8) | 8.1 (6.1 to 10.7) |
| OPSONO-1 3 Mth post dose 3 | 58.8 (38.2 to 90.7) | 57.5 (37.8 to 87.5) |
| OPSONO-4 1 Mth post dose 2 | 461.9 (377.9 to 564.5) | 427.2 (327.0 to 558.0) |
| OPSONO-4 5 Mth post dose 2 | 27.0 (18.6 to 39.2) | 27.4 (18.6 to 40.4) |
| OPSONO-4 3 Mth post dose 3 | 260.0 (190.0 to 355.8) | 241.1 (170.4 to 341.0) |
| OPSONO-5 1 Mth post dose 2 | 49.1 (37.0 to 65.0) | 49.1 (36.2 to 66.6) |
| OPSONO-5 5 Mth post dose 2 | 11.8 (9.3 to 15.1) | 12.6 (9.7 to 16.4) |
| OPSONO-5 3 Mth post dose 3 | 58.2 (44.0 to 77.0) | 47.0 (34.4 to 64.2) |
| OPSONO-6B 1 Mth post dose 2 | 359.8 (240.2 to 539.0) | 331.7 (223.1 to 493.2) |
| OPSONO-6B 5 Mth post dose 2 | 159.1 (102.0 to 248.0) | 111.1 (68.3 to 180.7) |
| OPSONO-6B 3 Mth post dose 3 | 214.7 (146.2 to 315.1) | 192.0 (130.0 to 283.6) |
| OPSONO-7F 1 Mth post dose 2 | 2643.3 (2122.6 to 3291.6) | 2336.3 (1923.9 to 2837.3) |
| OPSONO-7F 5 Mth post dose 2 | 1258.2 (972.6 to 1627.6) | 1466.4 (1150.1 to 1869.7) |
| OPSONO-7F 3 Mth post dose 3 | 2767.6 (2261.7 to 3386.7) | 2963.6 (2379.0 to 3691.9) |
| OPSONO-9V 1 Mth post dose 2 | 783.7 (609.0 to 1008.5) | 763.2 (625.4 to 931.4) |
| OPSONO-9V 5 Mth post dose 2 | 241.3 (159.0 to 366.2) | 163.3 (113.8 to 234.3) |
| OPSONO-9V 3 Mth post dose 3 | 1044.3 (818.8 to 1332.0) | 712.4 (534.2 to 950.0) |
| OPSONO-14 1 Mth post dose 2 | 349.7 (231.7 to 527.8) | 310.5 (200.1 to 481.9) |
| OPSONO-14 5 Mth post dose 2 | 54.3 (35.5 to 83.0) | 40.2 (26.6 to 60.8) |
| OPSONO-14 3 Mth post dose 3 | 335.9 (257.2 to 438.7) | 254.6 (180.4 to 359.4) |
| OPSONO-18C 1 Mth post dose 2 | 464.7 (317.0 to 681.2) | 459.7 (330.7 to 639.1) |
| OPSONO-18C 5 Mth post dose 2 | 28.4 (20.3 to 39.7) | 33.6 (23.5 to 47.8) |
| OPSONO-18C 3 Mth post dose 3 | 562.8 (405.0 to 782.0) | 522.0 (390.0 to 698.7) |
| OPSONO-19F 1 Mth post dose 2 | 299.3 (213.5 to 419.6) | 284.7 (201.1 to 403.1) |
| OPSONO-19F 5 Mth post dose 2 | 35.5 (26.0 to 48.3) | 38.7 (27.6 to 54.3) |
| OPSONO-19F 3 Mth post dose 3 | 203.6 (140.5 to 295.1) | 168.1 (110.0 to 256.8) |
| OPSONO-23F 1 Mth post dose 2 | 539.6 (343.1 to 848.6) | 493.9 (308.8 to 789.8) |
| OPSONO-23F 5 Mth post dose 2 | 156.5 (88.7 to 276.3) | 158.6 (91.1 to 276.1) |
| OPSONO-23F 3 Mth post dose 3 | 612.2 (395.6 to 947.4) | 835.7 (548.1 to 1274.1) |
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Titers | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| OPSONO-3 1 Mth post dose 3 | 5.3 (4.3 to 6.4) | 4.5 (4.0 to 5.1) | 4.8 (4.2 to 5.5) | 98.3 (82.8 to 116.7) |
| OPSONO-3 5 Mth post dose 3 | 7.1 (5.6 to 9.0) | 5.5 (4.5 to 6.6) | 6.7 (5.3 to 8.5) | 15.1 (11.0 to 20.6) |
| OPSONO-3 8 Mth post dose 3 | 8.1 (6.3 to 10.5) | 8.3 (6.3 to 11.0) | 7.8 (6.1 to 10.1) | 12.3 (9.0 to 16.7) |
| OPSONO-6A 1 Mth post dose 3 | 13.7 (9.0 to 20.9) | 11.8 (8.0 to 17.4) | 11.3 (7.7 to 16.5) | 2770.0 (2216.1 to 3462.4) |
| OPSONO-6A 5 Mth post dose 3 | 14.8 (9.5 to 23.2) | 12.0 (8.0 to 17.9) | 20.2 (12.7 to 32.0) | 602.0 (433.4 to 836.2) |
| OPSONO-6A 8 Mth post dose 3 | 14.8 (9.4 to 23.3) | 12.4 (8.1 to 19.1) | 18.5 (11.7 to 29.3) | 260.1 (167.4 to 404.2) |
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Titers | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| OPSONO-3 1 Mth post dose 2 | 4.7 (4.2 to 5.4) | 5.1 (4.2 to 6.1) |
| OPSONO-3 5 Mth post dose 2 | 5.9 (4.8 to 7.3) | 5.9 (4.6 to 7.6) |
| OPSONO-3 3 Mth post dose 3 | 7.4 (5.7 to 9.6) | 6.8 (5.4 to 8.4) |
| OPSONO-6A 1 Mth post dose 2 | 6.7 (5.1 to 8.8) | 6.7 (5.1 to 8.7) |
| OPSONO-6A 5 Mth post dose 2 | 12.4 (8.4 to 18.3) | 12.2 (8.2 to 18.3) |
| OPSONO-6A 3 Mth post dose 3 | 12.6 (8.3 to 19.2) | 10.0 (6.7 to 15.0) |
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Titers | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| OPSONO-19A 1 Mth post dose 3 | 347.0 (238.0 to 505.9) | 281.1 (192.8 to 409.8) | 369.8 (257.5 to 531.0) | 2652.8 (2277.5 to 3089.9) |
| OPSONO-19A 5 Mth post dose 3 | 120.4 (91.9 to 157.8) | 121.6 (94.3 to 156.8) | 140.2 (102.1 to 192.4) | 704.2 (498.5 to 994.8) |
| OPSONO-19A 8 Mth post dose 3 | 155.2 (109.1 to 220.9) | 151.5 (110.0 to 208.7) | 138.7 (101.3 to 190.0) | 394.4 (261.8 to 594.2) |
The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) to the serotype-specific Lower Limit of Quantification ( = 143). This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Titers | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| OPSONO-19A 1 Mth post dose 2 | 231.3 (164.5 to 325.4) | 177.4 (129.4 to 243.2) |
| OPSONO-19A 5 Mth post dose 2 | 99.1 (80.0 to 122.7) | 107.4 (84.5 to 136.5) |
| OPSONO-19A 3 Mth post dose 3 | 274.2 (187.6 to 400.8) | 361.2 (247.5 to 527.2) |
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
No measurements were reported for this outcome.
No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.
No measurements were reported for this outcome.
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
No measurements were reported for this outcome.
The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
No measurements were reported for this outcome.
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
| IU/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Anti-D 1 Mth post dose 3 | 2.499 (2.111 to 2.959) | 2.696 (2.381 to 3.053) | 2.874 (2.524 to 3.272) | 1.531 (1.330 to 1.762) |
| Anti-T 1 Mth post dose 3 | 4.977 (4.127 to 6.002) | 5.113 (4.294 to 6.089) | 4.709 (3.994 to 5.551) | 4.047 (3.462 to 4.731) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.
| IU/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Anti-D 1 Mth post dose 2 | 2.591 (2.213 to 3.033) | 2.560 (2.207 to 2.969) |
| Anti-T 1 Mth post dose 2 | 5.714 (4.816 to 6.781) | 4.738 (3.905 to 5.749) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
| EL.U/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 111.9 (99.4 to 125.8) | 110.3 (99.3 to 122.5) | 105.8 (94.4 to 118.6) | 117.0 (105.0 to 130.3) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.
| EL.U/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 123.2 (112.0 to 135.5) | 114.7 (101.3 to 129.9) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
| µg/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 23.381 (19.326 to 28.287) | 19.397 (15.319 to 24.561) | 19.239 (15.085 to 24.537) | 18.981 (15.244 to 23.635) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.
| µg/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 21.274 (17.909 to 25.272) | 21.150 (17.427 to 25.669) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
| mIU/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 1235.8 (946.9 to 1612.9) | 1165.8 (910.7 to 1492.3) | 990.1 (757.6 to 1294.0) | 1206.6 (946.2 to 1538.7) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.
| mIU/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 1318.5 (1062.5 to 1636.3) | 976.5 (724.2 to 1316.8) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
| Titers | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Anti-Polio 1 - 1 Mth post dose 3 | 413.2 (287.0 to 594.9) | 314.8 (202.7 to 488.7) | 447.9 (278.5 to 720.1) | 398.3 (256.6 to 618.3) |
| Anti-Polio 2 - 1 Mth post dose 3 | 545.8 (371.6 to 801.6) | 619.5 (462.0 to 830.7) | 514.2 (353.8 to 747.2) | 536.9 (400.6 to 719.6) |
| Anti-Polio 3 - 1 Mth post dose 3 | 135.4 (91.5 to 200.5) | 166.0 (124.5 to 221.5) | 110.1 (72.5 to 167.2) | 191.8 (129.4 to 284.4) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.
| Titers | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Anti-Polio 1 - 1 Mth post dose 2 | 330.3 (208.6 to 523.0) | 415.6 (286.7 to 602.6) |
| Anti-Polio 2 - 1 Mth post dose 2 | 486.7 (319.7 to 741.1) | 702.9 (529.6 to 932.8) |
| Anti-Polio 3 - 1 Mth post dose 2 | 106.9 (71.8 to 159.1) | 181.1 (131.7 to 249.0) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
| mIU/mL | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 329.2 (272.6 to 397.5) | 298.6 (254.9 to 349.8) | 295.8 (237.2 to 368.8) | 274.1 (227.7 to 330.0) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.
| mIU/mL | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Concentrations of Antibodies Against Measles (Anti-Measles) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 284.5 (240.9 to 336.0) | 305.9 (256.5 to 364.8) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
| Titers | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule | 334.0 (250.6 to 445.1) | 264.7 (201.0 to 348.5) | 379.9 (293.2 to 492.2) | 306.7 (242.9 to 387.3) |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.
| Titers | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Titers of Antibodies Against Yellow Fever (Anti-YF) - For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule | 342.0 (252.2 to 463.7) | 239.0 (176.0 to 324.5) |
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar 13 3+0d Group |
|---|---|---|---|---|
| Any pain | 108 | 121 | 123 | 115 |
| Grade 3 pain | 0 | 1 | 0 | 0 |
| Any redness | 8 | 7 | 9 | 5 |
| Grade 3 redness | 0 | 1 | 1 | 0 |
| Any swelling | 30 | 45 | 40 | 37 |
| Grade 3 swelling | 7 | 10 | 17 | 7 |
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Any pain | 97 | 102 |
| Grade 3 pain | 1 | 1 |
| Any redness | 3 | 5 |
| Grade 3 redness | 0 | 0 |
| Any swelling | 35 | 31 |
| Grade 3 swelling | 9 | 4 |
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Any pain | 21 | 26 |
| Grade 3 pain | 0 | 0 |
| Any redness | 0 | 0 |
| Grade 3 redness | 0 | 0 |
| Any swelling | 4 | 8 |
| Grade 3 swelling | 1 | 3 |
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar 13 3+0d Group |
|---|---|---|---|---|
| Any Drowsiness | 43 | 46 | 38 | 44 |
| Grade 3 Drowsiness | 0 | 0 | 0 | 0 |
| Related Drowsiness | 43 | 45 | 38 | 43 |
| Any Irritability/fussiness | 139 | 133 | 141 | 136 |
| Grade 3 Irritability/fussiness | 6 | 4 | 4 | 7 |
| Related Irritability/fussiness | 138 | 132 | 138 | 136 |
| Any Loss of appetite | 32 | 30 | 27 | 34 |
| Grade 3 Loss of appetite | 0 | 0 | 1 | 0 |
| Related Loss of appetite | 32 | 29 | 26 | 34 |
| Any Fever | 104 | 100 | 105 | 106 |
| Grade 3 Fever | 0 | 0 | 0 | 0 |
| Related Fever | 102 | 100 | 104 | 104 |
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Any Drowsiness | 47 | 44 |
| Grade 3 Drowsiness | 0 | 0 |
| Related Drowsiness | 46 | 43 |
| Any Fever | 92 | 84 |
| Grade 3 Fever | 0 | 0 |
| Related Fever | 89 | 84 |
| Any Irritability/fussiness | 131 | 128 |
| Grade 3 Irritability/fussiness | 1 | 2 |
| Related Irritability/fussiness | 128 | 126 |
| Any Loss of appetite | 24 | 25 |
| Grade 3 Loss of appetite | 0 | 0 |
| Related Loss of appetite | 24 | 24 |
Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (\>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Any Drowsiness | 12 | 4 |
| Grade 3 Drowsiness | 0 | 0 |
| Related Drowsiness | 12 | 4 |
| Any Fever | 32 | 27 |
| Grade 3 Fever | 0 | 1 |
| Related Fever | 30 | 25 |
| Any Irritability/fussiness | 27 | 19 |
| Grade 3 Irritability/fussiness | 0 | 0 |
| Related Irritability/fussiness | 27 | 19 |
| Any Loss of appetite | 3 | 5 |
| Grade 3 Loss of appetite | 0 | 0 |
| Related Loss of appetite | 3 | 4 |
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar 13 3+0d Group |
|---|---|---|---|---|
| Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 113 | 114 | 123 | 114 |
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 84 | 95 |
An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Number of Subjects With Any Unsolicited Adverse Events (AEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 7 | 2 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule | 1 | 4 | 3 | 2 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| Number of Subjects With Any Serious Adverse Events (SAEs) - For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule | 4 | 5 |
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 165 | 158 | 166 | 155 |
| At 5 Mth post dose 3 | 166 | 161 | 176 | 168 |
| At 8 Mth post dose 3 | 174 | 166 | 174 | 171 |
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 159 | 162 |
| At 5 Mth post-dose 2 | 164 | 173 |
| At 3 Mth post-dose 3 | 178 | 176 |
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 24 | 31 | 34 | 29 |
| At 5 Mth post dose 3 | 25 | 23 | 28 | 30 |
| At 8 Mth post dose 3 | 24 | 15 | 16 | 21 |
Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 27 | 24 |
| At 5 Mth post-dose 2 | 24 | 23 |
| At 3 Mth post-dose 3 | 18 | 19 |
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 57 | 56 | 60 | 48 |
| At 5 Mth post dose 3 | 54 | 48 | 58 | 46 |
| At 8 Mth post dose 3 | 45 | 42 | 47 | 42 |
Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 62 | 50 |
| At 5 Mth post-dose 2 | 45 | 49 |
| At 3 Mth post-dose 3 | 58 | 52 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 29 | 33 | 28 | 37 |
| At 5 Mth post dose 3 | 27 | 28 | 28 | 30 |
| At 8 Mth post dose 3 | 9 | 13 | 12 | 9 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 26 | 23 |
| At 5 Mth post-dose 2 | 20 | 32 |
| At 3 Mth post-dose 3 | 9 | 11 |
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 88 | 98 | 104 | 100 |
| At 5 Mth post dose 3 | 72 | 73 | 78 | 88 |
| At 8 Mth post dose 3 | 74 | 67 | 70 | 74 |
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 86 | 93 |
| At 5 Mth post-dose 2 | 73 | 84 |
| At 3 Mth post-dose 3 | 56 | 83 |
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 5 | 4 | 5 | 4 |
| At 5 Mth post dose 3 | 4 | 3 | 4 | 1 |
| At 8 Mth post dose 3 | 4 | 6 | 7 | 6 |
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 6 | 4 |
| At 5 Mth post-dose 2 | 2 | 4 |
| At 3 Mth post-dose 3 | 5 | 2 |
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 44 | 44 | 54 | 50 |
| At 5 Mth post dose 3 | 36 | 37 | 39 | 37 |
| At 8 Mth post dose 3 | 13 | 17 | 25 | 11 |
Positive cultures of other bacterial pathogens \[such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis\] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 46 | 62 |
| At 5 Mth post-dose 2 | 32 | 40 |
| At 3 Mth post-dose 3 | 21 | 17 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 124 | 106 | 120 | 112 |
| At 5 Mth post dose 3 | 108 | 122 | 131 | 126 |
| At 8 Mth post dose 3 | 121 | 115 | 122 | 122 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 117 | 128 |
| At 5 Mth post-dose 2 | 119 | 138 |
| At 3 Mth post-dose 3 | 129 | 117 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 136 | 130 | 142 | 133 |
| At 5 Mth post dose 3 | 128 | 130 | 145 | 142 |
| At 8 Mth post dose 3 | 139 | 128 | 136 | 135 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 136 | 141 |
| At 5 Mth post-dose 2 | 136 | 155 |
| At 3 Mth post-dose 3 | 144 | 131 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.
| Participants | 10PP-HD 3+0d Group | 10PP-LD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group |
|---|---|---|---|---|
| At 1 Mth post dose 3 | 17 | 21 | 16 | 19 |
| At 5 Mth post dose 3 | 24 | 23 | 25 | 24 |
| At 8 Mth post dose 3 | 9 | 10 | 10 | 6 |
This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.
| Participants | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|
| At 1 Mth post-dose 2 | 12 | 12 |
| At 5 Mth post-dose 2 | 20 | 25 |
| At 3 Mth post-dose 3 | 9 | 8 |
Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
| Samples | Total "All 5" Group |
|---|---|
| Positive isolates | 347 |
| Protein sequenced | 347 |
| Protein variants | 18 |
| Samples with Variant 1 | 216 |
Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).
| Samples | Total "All 5" Group |
|---|---|
| Positive isolates | 342 |
| Protein sequenced | 321 |
| Protein variants | 84 |
| Samples with Variant 1 | 1 |
Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant. The samples without gene detected were considered as negative for Ply (Ply negative).
| Samples | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|
| Variant 1 - AA = 0 at Month 0 | 5 | 8 | 7 | 4 | 8 |
| Variant 2 - AA = 1 at Month 0 | 4 | 0 | 1 | 4 | 1 |
| Variant 15 - AA = 1 at Month 0 | 1 | 0 | 0 | 2 | 0 |
| Variant GSK 24 - AA = 1 at Month 0 | 0 | 0 | 1 | 0 | 0 |
| Variant GSK 28 - AA = 1 at Month 0 | 0 | 0 | 1 | 0 | 0 |
| Variant GSK 33 - AA = 3 at Month 0 | 0 | 0 | 0 | 0 | 1 |
| Variant GSK 30 - AA = 4 at Month 0 | 0 | 1 | 0 | 0 | 0 |
| Variant GSK 31 - AA = 6 at Month 0 | 0 | 1 | 0 | 0 | 0 |
| Ply negative at Month 0 | 0 | 0 | 0 | 0 | 0 |
| Variant 1 - AA = 0 at Month 3 | 11 | 13 | 10 | 14 | 9 |
| Variant 2 - AA = 1 at Month 3 | 4 | 7 | 6 | 4 | 8 |
| Variant 15 - AA = 1 at Month 3 | 2 | 0 | 2 | 1 | 0 |
| Variant GSK 24 - AA = 1 at Month 3 | 2 | 0 | 1 | 1 | 0 |
| Variant 11 - AA = 2 at Month 3 | 0 | 0 | 0 | 0 | 1 |
| Variant GSK 23 - AA = 2 at Month 3 | 0 | 0 | 0 | 0 | 2 |
| Ply negative at Month 3 | 1 | 0 | 1 | 0 | 0 |
| Variant 1 - AA = 0 at Month 7 | 14 | 15 | 10 | 13 | 10 |
| Variant 2 - AA = 1 at Month 7 | 4 | 4 | 6 | 4 | 7 |
| Variant 15 - AA = 1 at Month 7 | 2 | 0 | 1 | 1 | 1 |
| Variant GSK 24 - AA = 1 at Month 7 | 0 | 0 | 0 | 1 | 0 |
| Variant GSK 29 - AA = 1 at Month 7 | 0 | 0 | 0 | 0 | 1 |
| Variant 7 - AA = 2 at Month 7 | 0 | 1 | 1 | 1 | 0 |
| Variant GSK 21 - AA = 2 at Month 7 | 0 | 0 | 1 | 0 | 0 |
| Variant GSK 23 - AA = 2 at Month 7 | 0 | 0 | 0 | 0 | 1 |
| Variant GSK 27 - AA = 2 at Month 7 | 0 | 0 | 1 | 0 | 0 |
| Ply negative at Month 7 | 0 | 0 | 0 | 0 | 0 |
| Variant 1 - AA = 0 at Month 10 | 12 | 15 | 12 | 12 | 14 |
| Variant 2 - AA = 1 at Month 10 | 5 | 2 | 6 | 5 | 4 |
| Variant 15 - AA = 1 at Month 10 | 1 | 1 | 0 | 2 | 1 |
| Variant GSK 24 - AA = 1 at Month 10 | 0 | 0 | 0 | 0 | 1 |
| Variant GSK 25 - AA = 1 at Month 10 | 0 | 1 | 0 | 0 | 0 |
| Variant 7 - AA = 2 at Month 10 | 1 | 0 | 0 | 1 | 0 |
| Variant GSK 22 - AA = 2 at Month 10 | 0 | 0 | 1 | 0 | 0 |
| Variant GSK 26 - AA = 4 at Month 10 | 0 | 0 | 1 | 0 | 0 |
| Variant GSK 32 - AA = 7 at Month 10 | 1 | 0 | 0 | 0 | 0 |
| Ply negative at Month 10 | 0 | 1 | 0 | 0 | 0 |
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
| Percentage of protein identity | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|
| Median at Month 0 | 99.90 | 100 | 100 | 99.79 | 100 |
| Mean at Month 0 | 99.90 | 99.79 | 99.94 | 99.87 | 99.92 |
| Median at Month 3 | 100 | 100 | 100 | 100 | 99.79 |
| Mean at Month 3 | 99.91 | 99.93 | 99.90 | 99.94 | 99.85 |
| Median at Month 7 | 100 | 100 | 99.90 | 100 | 99.90 |
| Mean at Month 7 | 99.94 | 99.94 | 99.86 | 99.92 | 99.88 |
| Median at Month 10 | 100 | 100 | 100 | 100 | 100 |
| Mean at Month 10 | 99.84 | 99.95 | 99.87 | 99.91 | 99.94 |
Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed. PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix). The samples without gene detected were considered as negative for PhtD (PhtD negative).
| Samples | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|
| Variants number at Month 0 | 10 | 6 | 9 | 9 | 7 |
| Mix number at Month 0 | 0 | 1 | 1 | 0 | 2 |
| PhtD negative at Month 0 | 0 | 2 | 0 | 1 | 1 |
| Variants number at Month 3 | 16 | 16 | 18 | 16 | 16 |
| Mix number at Month 3 | 1 | 1 | 0 | 3 | 1 |
| PhtD negative at Month 3 | 1 | 0 | 1 | 0 | 0 |
| Variants number at Month 7 | 13 | 14 | 17 | 13 | 12 |
| Mix number at Month 7 | 0 | 2 | 1 | 1 | 1 |
| PhtD negative at Month 7 | 0 | 0 | 0 | 0 | 0 |
| Variants number at Month 10 | 13 | 12 | 13 | 15 | 11 |
| Mix number at Month 10 | 1 | 0 | 1 | 1 | 3 |
| PhtD negative at Month 10 | 1 | 1 | 0 | 0 | 0 |
Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.
| Percentage of protein identity | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|
| Median at Month 0 | 96.3 | 96.7 | 95.8 | 96.7 | 95.7 |
| Mean at Month 0 | 95.2 | 97.0 | 96.7 | 96.3 | 96.3 |
| Median at Month 3 | 96.6 | 97.7 | 96.6 | 96.3 | 95.7 |
| Mean at Month 3 | 96.4 | 97.4 | 96.2 | 94.6 | 93.1 |
| Median at Month 7 | 97.6 | 96.2 | 97.4 | 97.6 | 95.7 |
| Mean at Month 7 | 96.7 | 95.6 | 95.7 | 96.7 | 94.7 |
| Median at Month 10 | 97.2 | 97.6 | 96.8 | 96.9 | 97.6 |
| Mean at Month 10 | 95.5 | 97.3 | 94.1 | 95.4 | 94.9 |
Collected over Solicited symptoms during the 4-day post-vaccination period in Cohort 1 and 2. Unsolicited AEs during 31-day post-vaccination period in Cohort 1 and 2. SAEs from Month 0 to Month 6 in Cohort 1 and from Month 0 to Month 10 in Cohort 2.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10PP-HD 1d Group | 0/60 (0%) | 0/60 (0%) | 9/60 (15%) |
| Prevnar 13 1d Group | 0/60 (0%) | 0/60 (0%) | 3/60 (5%) |
| 10PP-LD 3+0d Group | 0/200 (0%) | 1/200 (0.5%) | 186/200 (93%) |
| 10PP-HD 3+0d Group | 1/200 (0.5%) | 4/200 (2%) | 191/200 (95.5%) |
| Synflorix 3+0d Group | 0/200 (0%) | 3/200 (1.5%) | 193/200 (96.5%) |
| Prevnar 13 3+0d Group | 2/200 (1%) | 2/200 (1%) | 188/200 (94%) |
| 10PP-HD 2+1d Group | 2/200 (1%) | 4/200 (2%) | 189/200 (94.5%) |
| Synflorix 2+1d Group | 1/200 (0.5%) | 5/200 (2.5%) | 184/200 (92%) |
| Event | 10PP-HD 1d Group | Prevnar 13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar 13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 0/60 | 0/60 | 0/200 | 1/200 | 2/200 | 1/200 | 2/200 | 0/200 |
| GastroenteritisInfections and infestations | 0/60 | 0/60 | 0/200 | 1/200 | 0/200 | 0/200 | 1/200 | 1/200 |
| SepsisInfections and infestations | 0/60 | 0/60 | 0/200 | 0/200 | 1/200 | 1/200 | 0/200 | 1/200 |
| BronchiolitisInfections and infestations | 0/60 | 0/60 | 0/200 | 1/200 | 0/200 | 0/200 | 0/200 | 1/200 |
| BronchitisInfections and infestations | 0/60 | 0/60 | 0/200 | 0/200 | 0/200 | 0/200 | 0/200 | 1/200 |
| Febrile convulsionNervous system disorders | 0/60 | 0/60 | 0/200 | 0/200 | 0/200 | 0/200 | 0/200 | 1/200 |
| MalariaInfections and infestations | 0/60 | 0/60 | 1/200 | 0/200 | 0/200 | 0/200 | 0/200 | 0/200 |
| Meningitis bacterialInfections and infestations | 0/60 | 0/60 | 0/200 | 1/200 | 0/200 | 0/200 | 0/200 | 0/200 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 0/60 | 0/60 | 0/200 | 1/200 | 0/200 | 0/200 | 0/200 | 0/200 |
| Sudden infant death syndromeGeneral disorders | 0/60 | 0/60 | 0/200 | 0/200 | 0/200 | 0/200 | 1/200 | 0/200 |
| Event | 10PP-HD 1d Group | Prevnar 13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar 13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group |
|---|---|---|---|---|---|---|---|---|
| IrritabilityPsychiatric disorders | — | — | 139/200 | 133/200 | 141/200 | 136/200 | — | — |
| IrritabilityPsychiatric disorders | — | — | — | — | — | — | 131/200 | 128/200 |
| PainGeneral disorders | — | — | 108/200 | 121/200 | 123/200 | 115/200 | — | — |
| PyrexiaGeneral disorders | — | — | 105/200 | 104/200 | 106/200 | 106/200 | — | — |
| PainGeneral disorders | — | — | — | — | — | — | 97/200 | 102/200 |
| PyrexiaGeneral disorders | — | — | — | — | — | — | 93/200 | 89/200 |
| Respiratory tract infectionInfections and infestations | — | — | 80/200 | 68/200 | 80/200 | 80/200 | — | — |
| Respiratory tract infectionInfections and infestations | — | — | — | — | — | — | 56/200 | 58/200 |
| SomnolenceNervous system disorders | — | — | — | — | — | — | 47/200 | 44/200 |
| SomnolenceNervous system disorders | — | — | 43/200 | 46/200 | 38/200 | 44/200 | — | — |
| Age, Continuous(Years) | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 2.8 ± 0.40 | 2.9 ± 0.36 | NA ± NA | NA ± NA | NA ± NA | NA ± NA | NA ± NA | NA ± NA | 2.9 ± 0.38 |
| Age, Continuous(Weeks) | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | NA ± NA | NA ± NA | 8.5 ± 0.64 | 8.4 ± 0.61 | 8.4 ± 0.63 | 8.5 ± 0.69 | 8.5 ± 0.70 | 8.5 ± 0.70 | 8.5 ± 0.66 |
| Sex: Female, Male(Participants) | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 41 | 26 | NA | NA | NA | NA | NA | NA | NA |
| Male | 19 | 34 | NA | NA | NA | NA | NA | NA | NA |
| Sex: Female, Male(Participants) | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | NA | NA | 105 | 98 | 103 | 103 | 103 | 97 | NA |
| Male | NA | NA | 95 | 102 | 97 | 97 | 97 | 103 | NA |
| Race/Ethnicity, Customized(Participants) | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| African heritage | 60 | 60 | NA | NA | NA | NA | NA | NA | NA |
| Race/Ethnicity, Customized(Participants) | 10PP-HD 1d Group | Prevnar13 1d Group | 10PP-LD 3+0d Group | 10PP-HD 3+0d Group | Synflorix 3+0d Group | Prevnar13 3+0d Group | 10PP-HD 2+1d Group | Synflorix 2+1d Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| African heritage | NA | NA | 200 | 200 | 200 | 200 | 200 | 200 | NA |
Plan to share: Yes — IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Feb 2011 to primary completion in Mar 2013, 25 months.
Results were first posted in Apr 2014, 1 year 1 month after primary completion. A results delay was requested in Apr 2013.
Of 12 phase 2 interventional studies under Streptococcal Infections, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's 25 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Diphtheria-Tetanus-Pertussis Vaccine · Hiberix · Poliovirus Vaccine, Oral · Yellow Fever Vaccine