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CompletedNCT01175083Updated Jun 6, 2019Results posted

Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A

A Phase 3 interventional study of GSK1024850A (Synflorix) and Tritanrix-HepB/Hib in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 1 site in Burkina Faso. Open to participants aged 8 Weeks to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-06.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
8 Weeks to 23 Months
Sex
All
01

Study summary

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

Read the detailed description

This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.

02

Conditions studied

  • Infections, Streptococcal

Keywords

  • Immunogenicity
  • Booster vaccination
  • Catch-up vaccination
  • Pneumococcal vaccine
  • Pneumococcal disease
  • Sickle cell disease
  • Safety
03

In context

Streptococcal Infections

159 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.

This study's enrollment of 300 is above the median of 250 across 107 interventional studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Weeks to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).

  • A male or female between, and including:

    • 8 and 11 weeks of age at the time of the first vaccination for subjects in the \<6S and \<6NS groups or
    • 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or
    • 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
  • Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.

Additional inclusion criteria for children with SCD (\<6S, 7-11S and 12-23S groups):

  • Children with diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed hemoglobin status by hemoglobin chromatography and electrophoresis (\<6S group) or electrophoresis (7-11S and 12-23S groups).
  • Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context

Additional inclusion criteria for healthy children (\<6NS, 7-11NS and 12-23NS groups):

  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Children with negative diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.

Exclusion criteria

Exclusion Criteria:

  • Child in care
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Previous vaccination or planned vaccination during the study with any pneumococcal vacccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital malformations.
  • History of any neurological disorders or seizures.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Birth weight below 1500g.
  • Serious chronic illness other than SCD.

  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Additional exclusion criteria for children with SCD (\<6S, 7-11S and 12-23S groups):

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).

Additional exclusion criteria for healthy children (\<6 NS, 7-11NS and 12-23NS groups):

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Tritanrix-HepB/Hib+Polio Sabin <6S Group

    Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.

    Biological: GSK1024850A (Synflorix) · Biological: Tritanrix-HepB/Hib · Biological: Polio Sabin

  • Active comparator
    Tritanrix-HepB/Hib+Polio Sabin <6NS Group

    Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.

    Biological: GSK1024850A (Synflorix) · Biological: Tritanrix-HepB/Hib · Biological: Polio Sabin

  • Experimental
    Synflorix 7-11S Group

    Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.

    Biological: GSK1024850A (Synflorix)

  • Active comparator
    Synflorix 7-11NS Group

    Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.

    Biological: GSK1024850A (Synflorix)

  • Experimental
    Synflorix 12-23S Group

    Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

    Biological: GSK1024850A (Synflorix)

  • Active comparator
    Synflorix 12-23NS Group

    Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.

    Biological: GSK1024850A (Synflorix)

Interventions

06

What researchers measure

Primary outcomes

  1. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

    Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (\<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: One month after primary vaccination (Month 3)

  2. Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

    Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: One month after the primary vaccination (Month 3)

Secondary outcomes

  1. Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

    Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination

  2. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

    Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

  3. Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

    Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

  4. Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

    Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

  5. Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

    Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

  6. Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

    Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

  7. Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

    Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

  8. Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

    Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

  9. Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

    Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

  10. Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

    Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

    Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

  11. Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

    Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

    Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

  12. Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

    Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

    Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

  13. Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

    Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

    Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

  14. Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

    Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

    Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination

  15. Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

    Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

    Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose

  16. Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine

    Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL.

    Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

  17. Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine

    Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL.

    Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination

  18. Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

    Time frame: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

  19. Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

    Time frame: During the 4-day (Days 0-3) post-booster vaccination period

  20. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Time frame: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

  21. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

    Time frame: During the 4-day (Days 0-3) post-booster vaccination period

  22. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

    Time frame: Within the 31-day (Days 0-30) post-primary and post-booster vaccination period

  23. Number of Subjects With Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Time frame: During the entire study period from Month 0 to Month 9

07

Results

Posted Jun 6, 2019

Participant flow

Primary Epoch
Participant flow — Primary Epoch
MilestoneTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Started505050505050
Completed505050505047
Not completed000003
Withdrew: Withdrawal by subject000002
Withdrew: Lost to follow-up000001
Booster Epoch
Participant flow — Booster Epoch
MilestoneTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Started4949505000
Completed4949494900
Not completed001100
Withdrew: Death001000
Withdrew: Withdrawal by subject000100

Outcome measures

PrimaryConcentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (\<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
One month after primary vaccination (Month 3)
Reported as:
Geometric mean · µg/mL
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
µg/mLTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
Anti-13.51 (2.77 to 4.44)3.63 (2.91 to 4.53)
Anti-44.25 (3.18 to 5.67)3.51 (2.73 to 4.51)
Anti-55.15 (4.07 to 6.51)5.94 (4.91 to 7.18)
Anti-6B1.29 (0.83 to 1.99)1.13 (0.74 to 1.72)
Anti-7F4.91 (3.84 to 6.28)4.28 (3.49 to 5.26)
Anti-9V4.56 (3.51 to 5.92)4.59 (3.70 to 5.70)
Anti-144.30 (3.08 to 6.00)5.95 (4.27 to 8.29)
Anti-18C14.60 (11.01 to 19.36)11.33 (8.47 to 15.17)
Anti-19F11.87 (9.05 to 15.57)9.78 (7.01 to 13.64)
Anti-23F1.32 (0.90 to 1.93)1.41 (0.95 to 2.11)
PrimaryConcentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
One month after the primary vaccination (Month 3)
Reported as:
Geometric mean · EL.U/mL
Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
EL.U/mLTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines2789.09 (2313.89 to 3361.87)3065.40 (2530.54 to 3713.31)
SecondaryConcentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination
Reported as:
Geometric mean · μg/mL
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
μg/mLTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
Anti-1, Month 00.09 (0.06 to 0.12)0.09 (0.06 to 0.12)
Anti-1, Month 80.67 (0.54 to 0.84)0.69 (0.52 to 0.90)
Anti-1, Month 95.34 (4.07 to 7.02)5.14 (3.52 to 7.50)
Anti-4, Month 00.04 (0.03 to 0.06)0.06 (0.04 to 0.08)
Anti-4, Month 81.20 (0.91 to 1.59)1.08 (0.77 to 1.52)
Anti-4, Month 97.04 (5.53 to 8.97)6.02 (4.40 to 8.24)
Anti-5, Month 00.06 (0.05 to 0.09)0.07 (0.06 to 0.10)
Anti-5, Month 81.13 (0.87 to 1.47)1.23 (0.93 to 1.63)
Anti-5, Month 96.30 (4.94 to 8.04)6.91 (4.92 to 9.73)
Anti-6B, Month 00.07 (0.05 to 0.09)0.11 (0.07 to 0.18)
Anti-6B, Month 81.94 (1.55 to 2.44)1.62 (1.25 to 2.09)
Anti-6B, Month 95.07 (4.16 to 6.18)5.00 (3.71 to 6.74)
Anti-7F, Month 00.08 (0.06 to 0.11)0.13 (0.09 to 0.19)
Anti-7F, Month 81.83 (1.41 to 2.37)1.57 (1.21 to 2.05)
Anti-7F, Month 99.03 (7.18 to 11.37)8.19 (6.18 to 10.86)
Anti-9V, Month 00.12 (0.08 to 0.16)0.12 (0.09 to 0.16)
Anti-9V, Month 81.61 (1.17 to 2.21)1.44 (1.13 to 1.82)
Anti-9V, Month 98.19 (6.61 to 10.14)7.95 (5.94 to 10.63)
Anti-14, Month 00.77 (0.53 to 1.12)0.65 (0.42 to 0.99)
Anti-14, Month 82.58 (1.90 to 3.51)2.10 (1.32 to 3.34)
Anti-14, Month 98.66 (6.91 to 10.85)7.43 (4.72 to 11.70)
Anti-18C, Month 00.13 (0.10 to 0.18)0.13 (0.09 to 0.18)
Anti-18C, Month 83.82 (2.97 to 4.92)3.16 (2.32 to 4.31)
Anti-18C, Month 916.52 (12.81 to 21.32)16.74 (12.98 to 21.58)
Anti-19F, Month 00.34 (0.23 to 0.51)0.30 (0.21 to 0.44)
Anti-19F, Month 83.31 (2.51 to 4.38)3.27 (2.21 to 4.84)
Anti-19F, Month 910.96 (8.37 to 14.34)11.27 (8.18 to 15.54)
Anti-23F, Month 00.13 (0.09 to 0.20)0.10 (0.07 to 0.14)
Anti-23F, Month 80.67 (0.48 to 0.94)0.77 (0.51 to 1.17)
Anti-23F, Month 94.86 (3.34 to 7.07)4.54 (2.70 to 7.62)
SecondaryConcentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Reported as:
Geometric mean · µg/mL
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
µg/mLSynflorix 7-11S GroupSynflorix 7-11NS Group
Anti-1, Month 00.03 (0.03 to 0.03)0.04 (0.03 to 0.05)
Anti-1, Month 25.48 (4.34 to 6.93)3.99 (3.24 to 4.91)
Anti-1, Month 32.68 (2.12 to 3.39)2.44 (1.99 to 2.98)
Anti-1, Month 45.51 (4.27 to 7.10)4.92 (3.74 to 6.48)
Anti-4, Month 00.03 (0.03 to 0.04)0.03 (0.02 to 0.04)
Anti-4, Month 210.88 (8.94 to 13.24)7.55 (6.00 to 9.50)
Anti-4, Month 35.72 (4.66 to 7.03)4.32 (3.51 to 5.32)
Anti-4, Month 49.75 (7.67 to 12.39)7.88 (6.28 to 9.89)
Anti-5, Month 00.04 (0.03 to 0.06)0.06 (0.05 to 0.08)
Anti-5, Month 26.76 (5.14 to 8.89)4.59 (3.58 to 5.88)
Anti-5, Month 33.68 (2.87 to 4.73)3.40 (2.66 to 4.33)
Anti-5, Month 47.75 (6.05 to 9.92)7.87 (6.02 to 10.29)
Anti-6B, Month 00.03 (0.02 to 0.03)0.03 (0.02 to 0.03)
Anti-6B, Month 21.61 (1.03 to 2.52)1.48 (1.02 to 2.13)
Anti-6B, Month 31.51 (1.06 to 2.15)1.35 (0.98 to 1.87)
Anti-6B, Month 43.12 (2.10 to 4.64)2.93 (2.17 to 3.95)
Anti-7F, Month 00.04 (0.03 to 0.05)0.04 (0.03 to 0.05)
Anti-7F, Month 28.51 (6.94 to 10.42)6.67 (5.44 to 8.19)
Anti-7F, Month 35.46 (4.37 to 6.83)4.68 (3.76 to 5.81)
Anti-7F, Month 411.08 (8.90 to 13.81)10.29 (7.92 to 13.37)
Anti-9V, Month 00.04 (0.03 to 0.05)0.04 (0.03 to 0.05)
Anti-9V, Month 22.55 (1.86 to 3.49)1.67 (1.21 to 2.29)
Anti-9V, Month 31.90 (1.42 to 2.56)1.52 (1.16 to 2.00)
Anti-9V, Month 44.73 (3.40 to 6.58)3.76 (2.67 to 5.30)
Anti-14, Month 00.08 (0.06 to 0.12)0.07 (0.05 to 0.10)
Anti-14, Month 24.91 (3.48 to 6.95)4.81 (3.67 to 6.29)
Anti-14, Month 34.71 (3.45 to 6.43)4.98 (4.01 to 6.20)
Anti-14, Month 410.24 (7.96 to 13.18)10.69 (8.34 to 13.71)
Anti-18C, Month 00.03 (0.03 to 0.03)0.03 (0.03 to 0.04)
Anti-18C, Month 212.92 (9.93 to 16.82)14.62 (11.61 to 18.40)
Anti-18C, Month 38.43 (6.53 to 10.88)11.49 (9.24 to 14.29)
Anti-18C, Month 423.57 (18.38 to 30.22)31.88 (25.34 to 40.11)
Anti-19F, Month 00.05 (0.04 to 0.06)0.04 (0.04 to 0.06)
Anti-19F, Month 211.13 (7.97 to 15.54)9.77 (6.16 to 15.48)
Anti-19F, Month 36.54 (4.79 to 8.92)7.39 (5.04 to 10.81)
Anti-19F, Month 415.59 (11.24 to 21.62)15.85 (10.52 to 23.89)
Anti-23F, Month 00.03 (0.03 to 0.04)0.04 (0.03 to 0.05)
Anti-23F, Month 21.29 (0.79 to 2.10)0.93 (0.60 to 1.45)
Anti-23F, Month 31.00 (0.65 to 1.56)1.08 (0.74 to 1.56)
Anti-23F, Month 43.11 (1.85 to 5.24)3.17 (2.04 to 4.91)
SecondaryConcentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Reported as:
Geometric mean · μg/mL
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
μg/mLSynflorix 12-23S GroupSynflorix 12-23NS Group
Anti-1, Month 00.04 (0.03 to 0.05)0.04 (0.03 to 0.05)
Anti-1, Month 21.39 (1.07 to 1.80)1.49 (1.18 to 1.89)
Anti-1, Month 34.67 (3.75 to 5.81)4.26 (3.38 to 5.37)
Anti-4, Month 00.04 (0.03 to 0.05)0.04 (0.03 to 0.05)
Anti-4, Month 24.22 (3.23 to 5.51)3.74 (2.96 to 4.72)
Anti-4, Month 38.87 (7.03 to 11.19)7.02 (5.85 to 8.43)
Anti-5, Month 00.06 (0.05 to 0.08)0.08 (0.06 to 0.11)
Anti-5, Month 21.06 (0.77 to 1.47)1.10 (0.83 to 1.44)
Anti-5, Month 35.52 (4.23 to 7.20)4.07 (3.06 to 5.42)
Anti-6B, Month 00.03 (0.03 to 0.04)0.04 (0.03 to 0.05)
Anti-6B, Month 20.41 (0.28 to 0.62)0.34 (0.24 to 0.48)
Anti-6B, Month 31.37 (0.91 to 2.07)1.25 (0.87 to 1.79)
Anti-7F, Month 00.07 (0.05 to 0.11)0.05 (0.04 to 0.07)
Anti-7F, Month 22.74 (2.13 to 3.52)3.17 (2.56 to 3.93)
Anti-7F, Month 36.81 (5.32 to 8.70)6.36 (5.25 to 7.69)
Anti-9V, Month 00.08 (0.05 to 0.12)0.05 (0.04 to 0.07)
Anti-9V, Month 20.99 (0.72 to 1.34)0.83 (0.62 to 1.11)
Anti-9V, Month 32.35 (1.85 to 3.00)1.72 (1.31 to 2.25)
Anti-14, Month 00.11 (0.07 to 0.16)0.09 (0.06 to 0.12)
Anti-14, Month 21.87 (1.46 to 2.40)1.24 (0.92 to 1.66)
Anti-14, Month 37.59 (5.84 to 9.87)5.75 (4.33 to 7.62)
Anti-18C, Month 00.04 (0.03 to 0.06)0.05 (0.04 to 0.07)
Anti-18C, Month 26.21 (4.77 to 8.10)6.12 (4.56 to 8.21)
Anti-18C, Month 325.52 (20.66 to 31.53)22.64 (18.14 to 28.26)
Anti-19F, Month 00.06 (0.04 to 0.09)0.08 (0.05 to 0.12)
Anti-19F, Month 25.88 (4.44 to 7.80)5.12 (3.79 to 6.94)
Anti-19F, Month 318.00 (13.97 to 23.20)14.46 (10.81 to 19.34)
Anti-23F, Month 00.03 (0.03 to 0.04)0.05 (0.03 to 0.07)
Anti-23F, Month 20.50 (0.32 to 0.77)0.35 (0.25 to 0.49)
Anti-23F, Month 31.95 (1.32 to 2.87)1.40 (1.05 to 1.87)
SecondaryConcentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Reported as:
Geometric mean · µg/mL
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
µg/mLTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
Anti-6A, Month 00.10 (0.07 to 0.14)0.15 (0.10 to 0.23)
Anti-6A, Month 30.12 (0.08 to 0.17)0.10 (0.07 to 0.13)
Anti-6A, Month 80.40 (0.27 to 0.61)0.18 (0.10 to 0.30)
Anti-6A, Month 90.48 (0.31 to 0.74)0.36 (0.23 to 0.55)
Anti-19A, Month 00.24 (0.17 to 0.36)0.23 (0.16 to 0.33)
Anti-19A, Month 30.26 (0.17 to 0.39)0.25 (0.17 to 0.37)
Anti-19A, Month 80.23 (0.15 to 0.37)0.21 (0.13 to 0.35)
Anti-19A, Month 91.09 (0.65 to 1.83)0.85 (0.50 to 1.43)
SecondaryConcentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Reported as:
Geometric mean · Titer
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
TiterSynflorix 7-11S GroupSynflorix 7-11NS Group
Anti-6A, Month 00.03 (0.03 to 0.04)0.03 (0.03 to 0.04)
Anti-6A, Month 20.18 (0.11 to 0.30)0.16 (0.11 to 0.24)
Anti-6A, Month 30.23 (0.14 to 0.37)0.22 (0.16 to 0.32)
Anti-6A, Month 40.44 (0.28 to 0.70)0.43 (0.30 to 0.62)
Anti-19A, Month 00.04 (0.03 to 0.06)0.06 (0.04 to 0.10)
Anti-19A, Month 20.46 (0.28 to 0.76)0.77 (0.50 to 1.18)
Anti-19A, Month 30.44 (0.27 to 0.70)0.77 (0.51 to 1.17)
Anti-19A, Month 41.49 (0.93 to 2.38)2.35 (1.50 to 3.67)
SecondaryConcentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Reported as:
Geometric mean · Titer
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
TiterSynflorix 12-23S GroupSynflorix 12-23NS Group
Anti-6A, Month 00.03 (0.03 to 0.03)0.04 (0.03 to 0.05)
Anti-6A, Month 20.15 (0.10 to 0.23)0.12 (0.08 to 0.18)
Anti-6A, Month 30.39 (0.23 to 0.66)0.31 (0.20 to 0.48)
Anti-19A, Month 00.06 (0.04 to 0.09)0.07 (0.04 to 0.11)
Anti-19A, Month 20.77 (0.50 to 1.17)0.75 (0.47 to 1.19)
Anti-19A, Month 33.15 (2.13 to 4.65)2.79 (1.93 to 4.05)
SecondaryConcentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Reported as:
Geometric mean · EL.U/mL
Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
EL.U/mLTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
Anti-PD, Month 064.75 (50.56 to 82.92)70.97 (53.71 to 93.78)
Anti-PD, Month 8859.87 (681.75 to 1084.52)840.88 (641.50 to 1102.23)
Anti-PD, Month 92871.72 (2338.21 to 3526.96)3137.87 (2459.92 to 4002.68)
SecondaryConcentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Reported as:
Geometric mean · EL.U/mL
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
EL.U/mLSynflorix 7-11S GroupSynflorix 7-11NS Group
Anti-PD, Month 072.73 (57.23 to 92.42)88.74 (70.85 to 111.13)
Anti-PD, Month 21313.39 (1014.30 to 1700.67)1489.78 (1171.98 to 1893.76)
Anti-PD, Month 3932.52 (732.63 to 1186.96)1063.54 (844.52 to 1339.37)
Anti-PD, Month 42695.50 (2150.74 to 3378.24)2638.27 (2049.91 to 3395.49)
SecondaryConcentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Reported as:
Geometric mean · EL.U/mL
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
EL.U/mLSynflorix 12-23S GroupSynflorix 12-23NS Group
Anti-PD, Month 079.59 (62.08 to 102.04)76.22 (61.39 to 94.63)
Anti-PD, Month 2199.23 (150.51 to 263.72)184.34 (140.21 to 242.35)
Anti-PD, Month 31376.56 (1020.71 to 1856.46)760.99 (553.23 to 1046.77)
SecondaryOpsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame:
Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Reported as:
Geometric mean · Titer
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
TiterTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
OPA-1, Month 3106.4 (56.0 to 202.2)94.6 (49.9 to 179.5)
OPA-1, Month 811.7 (6.8 to 20.1)10.9 (6.0 to 20.1)
OPA-1, Month 9930.5 (606.3 to 1427.9)750.4 (401.4 to 1403.0)
OPA-4, Month 31316.6 (1014.0 to 1709.7)992.5 (680.0 to 1448.4)
OPA-4, Month 8222.1 (130.6 to 377.8)108.3 (51.6 to 227.6)
OPA-4, Month 92064.2 (1625.3 to 2621.8)2079.3 (1425.7 to 3032.7)
OPA-5, Month 3106.9 (66.8 to 171.2)119.4 (81.4 to 175.2)
OPA-5, Month 814.9 (8.9 to 24.9)15.8 (9.6 to 26.1)
OPA-5, Month 9273.2 (200.6 to 372.0)277.5 (168.8 to 456.1)
OPA-6B, Month 31043.3 (605.3 to 1798.3)446.2 (207.4 to 960.0)
OPA-6B, Month 8285.3 (150.1 to 542.1)245.6 (115.0 to 524.3)
OPA-6B, Month 9952.2 (638.8 to 1419.3)989.2 (530.6 to 1843.9)
OPA-7F, Month 34644.1 (3519.3 to 6128.4)4924.2 (3430.2 to 7068.8)
OPA-7F, Month 81747.2 (1225.4 to 2491.3)1585.7 (1133.8 to 2217.8)
OPA-7F, Month 97262.9 (5257.6 to 10033.1)8120.3 (5802.1 to 11364.8)
OPA-9V, Month 31438.6 (1084.0 to 1909.3)1116.8 (679.6 to 1835.2)
OPA-9V, Month 8215.5 (97.5 to 476.1)244.5 (123.9 to 482.2)
OPA-9V, Month 92062.3 (1569.0 to 2710.8)2987.2 (2149.4 to 4151.6)
OPA-14, Month 31689.9 (1090.7 to 2618.2)1062.3 (562.8 to 2005.2)
OPA-14, Month 8215.9 (113.6 to 410.1)132.5 (60.3 to 291.5)
OPA-14, Month 91571.5 (1114.2 to 2216.4)1454.1 (741.8 to 2850.5)
OPA-18C, Month 3873.8 (591.7 to 1290.4)524.7 (319.6 to 861.6)
OPA-18C, Month 846.5 (28.5 to 75.7)28.7 (17.5 to 47.3)
OPA-18C, Month 91246.0 (776.7 to 1999.0)1011.8 (686.4 to 1491.4)
OPA-19F, Month 3558.9 (376.3 to 830.2)266.1 (148.2 to 477.8)
OPA-19F, Month 860.7 (37.1 to 99.3)43.4 (22.6 to 83.2)
OPA-19F, Month 9652.9 (413.3 to 1031.5)486.7 (278.9 to 849.4)
OPA-23F, Month 3705.1 (309.2 to 1607.8)759.7 (326.7 to 1766.6)
OPA-23F, Month 885.2 (27.5 to 264.4)41.6 (14.6 to 118.9)
OPA-23F, Month 94231.2 (2793.7 to 6408.3)1454.0 (736.1 to 2872.3)
SecondaryOpsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame:
Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Reported as:
Geometric mean · Titer
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
TiterSynflorix 7-11S GroupSynflorix 7-11NS Group
OPA-1, Month 04.9 (3.8 to 6.3)4.5 (3.6 to 5.7)
OPA-1, Month 2134.7 (83.6 to 216.9)88.1 (53.7 to 144.6)
OPA-1, Month 374.2 (42.6 to 129.3)48.0 (26.6 to 86.7)
OPA-1, Month 4516.0 (307.6 to 865.7)511.3 (293.2 to 891.8)
OPA-4, Month 05.1 (3.6 to 7.2)11.8 (5.7 to 24.5)
OPA-4, Month 21636.3 (1217.5 to 2199.2)1771.1 (1359.0 to 2308.2)
OPA-4, Month 3812.7 (584.5 to 1130.1)1048.3 (790.4 to 1390.3)
OPA-4, Month 42130.5 (1639.1 to 2769.2)2415.5 (1686.5 to 3459.8)
OPA-5, Month 04.4 (3.8 to 5.1)4.0 (4.0 to 4.0)
OPA-5, Month 2105.7 (67.7 to 165.1)85.8 (59.4 to 124.0)
OPA-5, Month 354.1 (34.9 to 83.6)49.2 (31.7 to 76.3)
OPA-5, Month 4277.4 (180.7 to 425.7)289.6 (190.9 to 439.3)
OPA-6B, Month 07.9 (4.6 to 13.8)8.5 (4.7 to 15.4)
OPA-6B, Month 2702.5 (413.2 to 1194.2)696.6 (388.5 to 1249.2)
OPA-6B, Month 3708.3 (422.9 to 1186.1)615.5 (337.3 to 1123.1)
OPA-6B, Month 41360.0 (860.2 to 2150.3)1305.4 (731.9 to 2328.4)
OPA-7F, Month 0215.3 (91.2 to 508.1)643.5 (293.4 to 1411.7)
OPA-7F, Month 26694.3 (5055.1 to 8864.9)10452.0 (7782.7 to 14036.6)
OPA-7F, Month 37776.9 (6000.8 to 10078.7)9336.3 (6752.4 to 12908.9)
OPA-7F, Month 410854.8 (9051.6 to 13017.2)9362.8 (6882.3 to 12737.3)
OPA-9V, Month 016.9 (8.3 to 34.5)20.3 (9.2 to 44.5)
OPA-9V, Month 22858.2 (1875.3 to 4356.2)2667.9 (1677.9 to 4242.0)
OPA-9V, Month 31982.9 (1192.1 to 3298.2)1986.2 (1167.8 to 3378.2)
OPA-9V, Month 43047.9 (2389.7 to 3887.3)2719.2 (1681.0 to 4398.9)
OPA-14, Month 05.5 (3.8 to 8.1)5.9 (3.8 to 9.1)
OPA-14, Month 22109.5 (1299.0 to 3425.9)4009.9 (2501.9 to 6426.7)
OPA-14, Month 31431.6 (865.2 to 2368.6)2128.3 (1477.5 to 3065.9)
OPA-14, Month 43414.9 (2237.4 to 5211.9)3717.3 (2403.9 to 5748.5)
OPA-18C, Month 04.1 (3.9 to 4.5)4.6 (3.4 to 6.2)
OPA-18C, Month 2744.4 (393.3 to 1409.2)1605.6 (937.1 to 2751.1)
OPA-18C, Month 3411.4 (214.4 to 789.7)746.4 (430.5 to 1294.1)
OPA-18C, Month 42218.9 (1577.5 to 3121.2)3238.7 (1874.7 to 5595.0)
OPA-19F, Month 04.2 (3.8 to 4.7)4.0 (4.0 to 4.0)
OPA-19F, Month 2393.4 (214.4 to 722.0)491.5 (256.8 to 940.6)
OPA-19F, Month 3160.2 (86.8 to 295.6)279.5 (161.1 to 484.9)
OPA-19F, Month 41347.7 (813.6 to 2232.3)1174.4 (605.6 to 2277.3)
OPA-23F, Month 07.6 (4.1 to 13.9)15.3 (6.4 to 36.6)
OPA-23F, Month 21545.1 (788.3 to 3028.2)2107.5 (1155.0 to 3845.5)
OPA-23F, Month 31168.8 (560.8 to 2435.8)1026.2 (458.3 to 2298.0)
OPA-23F, Month 42038.8 (977.1 to 4254.4)3525.1 (1974.2 to 6294.4)
SecondaryOpsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame:
Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Reported as:
Geometric mean · Titer
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
TiterSynflorix 12-23S GroupSynflorix 12-23NS Group
OPA-1, Month 06.9 (4.5 to 10.8)5.6 (4.2 to 7.6)
OPA-1, Month 29.3 (6.1 to 14.3)10.9 (6.8 to 17.4)
OPA-1, Month 3195.7 (119.9 to 319.3)115.1 (64.0 to 206.8)
OPA-4, Month 08.0 (4.7 to 13.6)7.3 (4.3 to 12.3)
OPA-4, Month 21086.3 (758.4 to 1555.9)1539.4 (1128.4 to 2100.1)
OPA-4, Month 32089.7 (1635.0 to 2670.8)3193.9 (2241.3 to 4551.4)
OPA-5, Month 05.5 (4.2 to 7.4)4.4 (3.6 to 5.4)
OPA-5, Month 29.8 (7.1 to 13.7)9.6 (6.6 to 13.7)
OPA-5, Month 3151.3 (99.8 to 229.2)84.0 (53.5 to 131.8)
OPA-6B, Month 013.6 (6.7 to 27.6)9.9 (5.2 to 18.7)
OPA-6B, Month 2345.1 (172.4 to 690.7)278.4 (131.8 to 588.4)
OPA-6B, Month 3748.4 (425.9 to 1315.0)866.4 (511.8 to 1466.7)
OPA-7F, Month 01436.6 (1014.4 to 2034.6)1228.1 (783.3 to 1925.5)
OPA-7F, Month 25462.3 (4108.9 to 7261.4)5802.2 (4678.6 to 7195.6)
OPA-7F, Month 310279.4 (7836.7 to 13483.6)10131.4 (8303.7 to 12361.6)
OPA-9V, Month 0119.5 (50.4 to 283.2)81.3 (35.7 to 185.0)
OPA-9V, Month 21976.2 (1392.6 to 2804.4)2359.0 (1514.3 to 3674.9)
OPA-9V, Month 33778.2 (2880.0 to 4956.4)4276.8 (3122.3 to 5858.3)
OPA-14, Month 016.3 (8.3 to 31.8)12.0 (5.3 to 27.0)
OPA-14, Month 2711.2 (400.7 to 1262.4)865.6 (583.2 to 1284.9)
OPA-14, Month 32704.5 (1856.4 to 3940.0)2737.5 (1890.0 to 3965.1)
OPA-18C, Month 04.9 (4.0 to 6.0)4.0 (4.0 to 4.0)
OPA-18C, Month 21035.5 (507.6 to 2112.5)449.2 (222.8 to 905.9)
OPA-18C, Month 32873.1 (2070.0 to 3987.6)2126.8 (1509.7 to 2996.3)
OPA-19F, Month 05.5 (4.2 to 7.3)4.0 (4.0 to 4.0)
OPA-19F, Month 2229.1 (132.9 to 395.0)248.0 (143.0 to 430.1)
OPA-19F, Month 31845.3 (1169.3 to 2912.1)1271.4 (825.4 to 1958.3)
OPA-23F, Month 068.1 (21.1 to 219.6)37.6 (12.3 to 114.3)
OPA-23F, Month 22572.2 (1264.1 to 5233.9)2433.6 (1309.7 to 4522.0)
OPA-23F, Month 35016.6 (3176.6 to 7922.4)5325.4 (2857.8 to 9923.9)
SecondaryOpsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines

Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame:
Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Reported as:
Geometric mean · Titer
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
TiterTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
OPA-6A, Month 324.73 (11.46 to 53.37)9.45 (5.32 to 16.75)
OPA-6A, Month 818.23 (8.97 to 37.09)17.59 (8.08 to 38.30)
OPA-6A, Month 935.35 (15.60 to 80.12)30.70 (12.14 to 77.64)
OPA-19A, Month 39.42 (5.65 to 15.70)5.04 (3.83 to 6.63)
OPA-19A, Month 86.31 (4.28 to 9.32)5.83 (3.95 to 8.61)
OPA-19A, Month 922.06 (9.49 to 51.30)19.44 (10.25 to 36.86)
SecondaryOpsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose

Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame:
Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Reported as:
Geometric mean · Titer
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
TiterSynflorix 7-11S GroupSynflorix 7-11NS Group
OPA-6A, Month 04.81 (3.71 to 6.24)5.02 (3.64 to 6.90)
OPA-6A, Month 240.59 (19.11 to 86.23)51.23 (22.85 to 114.88)
OPA-6A, Month 338.11 (17.04 to 85.21)36.27 (16.89 to 77.89)
OPA-6A, Month 477.09 (35.58 to 167.04)98.18 (43.05 to 223.96)
OPA-19A, Month 04.49 (3.91 to 5.16)4.33 (3.68 to 5.10)
OPA-19A, Month 215.21 (7.95 to 29.08)108.31 (49.55 to 236.78)
OPA-19A, Month 314.65 (7.71 to 27.81)19.40 (8.04 to 46.82)
OPA-19A, Month 476.09 (30.50 to 189.83)449.06 (170.05 to 1185.87)
SecondaryOpsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose

Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.

Time frame:
Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Reported as:
Geometric mean · Titer
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
TiterSynflorix 12-23S GroupSynflorix 12-23NS Group
OPA-6A, Month 09.26 (5.76 to 14.89)6.35 (4.02 to 10.02)
OPA-6A, Month 282.82 (40.27 to 170.33)77.25 (31.81 to 187.64)
OPA-6A, Month 3147.91 (63.11 to 346.68)157.37 (59.23 to 418.11)
OPA-19A, Month 05.85 (4.27 to 8.01)6.32 (4.09 to 9.76)
OPA-19A, Month 228.37 (11.84 to 67.98)25.68 (11.60 to 56.84)
OPA-19A, Month 3214.17 (75.58 to 606.93)321.14 (144.75 to 712.50)
SecondaryConcentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine

Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL.

Time frame:
Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Reported as:
Geometric mean · IU/mL
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
IU/mLTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
Anti-DT, Month 00.07 (0.05 to 0.08)0.06 (0.05 to 0.07)
Anti-DT, Month 33.22 (2.59 to 4.00)3.50 (2.82 to 4.34)
Anti-DT, Month 80.62 (0.50 to 0.77)0.90 (0.72 to 1.12)
Anti-DT, Month 96.58 (5.44 to 7.97)7.55 (6.11 to 9.32)
Anti-TT, Month 01.54 (1.13 to 2.09)1.22 (0.85 to 1.76)
Anti-TT, Month 34.04 (3.26 to 5.01)4.13 (3.27 to 5.22)
Anti-TT, Month 81.19 (0.96 to 1.48)1.33 (1.08 to 1.63)
Anti-TT, Month 910.88 (9.24 to 12.81)11.11 (9.62 to 12.83)
SecondaryConcentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine

Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL.

Time frame:
Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Reported as:
Geometric mean · EL.U/mL
Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
EL.U/mLTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS Group
Anti-BPT, Month 07.71 (7.29 to 8.16)7.77 (7.39 to 8.17)
Anti-BPT, Month 3105.61 (86.93 to 128.30)101.74 (84.56 to 122.42)
Anti-BPT, Month 822.67 (17.45 to 29.45)22.69 (17.88 to 28.80)
Anti-BPT, Month 9177.87 (152.10 to 207.99)190.58 (167.67 to 216.63)
SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame:
During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Reported as:
Count of participants · Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
ParticipantsTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Any Pain, Dose 181271096
Grade 3 Pain, Dose 1000000
Any Redness, Dose 1000000
Grade 3 Redness, Dose 1000000
Any Swelling, Dose 1000011
Grade 3 Swelling, Dose 1000000
Any Pain, Dose 2775753
Grade 3 Pain, Dose 2000000
Any Redness, Dose 2000000
Grade 3 Redness, Dose 2000000
Any Swelling, Dose 2010100
Grade 3 Swelling, Dose 2000000
Any Pain, Dose 346————
Grade 3 Pain, Dose 300————
Any Redness, Dose 300————
Grade 3 Redness, Dose 300————
Any Swelling, Dose 300————
Grade 3 Swelling, Dose 300————
Any Pain, Across doses17231215139
Grade 3 Pain, Across doses000000
Any Redness, Across doses000000
Grade 3 Redness, Across doses000000
Any Swelling, Across doses010111
Grade 3 Swelling, Across doses000000
SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame:
During the 4-day (Days 0-3) post-booster vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
ParticipantsTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Any Pain11630——
Grade 3 Pain0000——
Any Redness0000——
Grade 3 Redness0000——
Any Swelling1010——
Grade 3 Swelling0000——
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame:
During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
ParticipantsTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Any Drowsiness, Dose 1000100
Grade 3 Drowsiness, Dose 1000000
Related Drowsiness, Dose 1000100
Any Irritability, Dose 1020010
Grade 3 Irritability, Dose 1000000
Related Irritability, Dose 1000010
Any Loss of appetite, Dose 1000001
Grade 3 Loss of appetite, Dose 1000000
Related Loss of appetite, Dose 1000001
Any Fever, Dose 1343122262115
Grade 3 Fever, Dose 1000000
Related Fever, Dose 1312919222113
Any Drowsiness, Dose 2000000
Grade 3 Drowsiness, Dose 2000000
Related Drowsiness, Dose 2000000
Any Irritability, Dose 2000010
Grade 3 Irritability, Dose 2000000
Related Irritability, Dose 2000010
Any Loss of appetite, Dose 2000000
Grade 3 Loss of appetite, Dose 2000000
Related Loss of appetite, Dose 2000000
Any Fever, Dose 2403022111212
Grade 3 Fever, Dose 2000000
Related Fever, Dose 23828209109
Any Drowsiness, Dose 300————
Grade 3 Drowsiness, Dose 300————
Related Drowsiness, Dose 300————
Any Irritability, Dose 334————
Grade 3 Irritability, Dose 300————
Related Irritability, Dose 333————
Any Loss of appetite, Dose 301————
Grade 3 Loss of appetite, Dose 300————
Related Loss of appetite, Dose 300————
Any Fever, Dose 33030————
Grade 3 Fever, Dose 300————
Related Fever, Dose 32628————
Any Drowsiness, Across doses000100
Grade 3 Drowsiness, Across doses000000
Related Drowsiness, Across doses000100
Any Irritability, Across doses360020
Grade 3 Irritability, Across doses000000
Related Irritability, Across doses330020
Any Loss of appetite, Across doses010001
Grade 3 Loss of appetite, Across doses000000
Related Loss of appetite, Across doses000001
Any Fever, Across doses484331292920
Grade 3 Fever, Across doses000000
Related Fever, Across doses464329252817
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame:
During the 4-day (Days 0-3) post-booster vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
ParticipantsTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Any Drowsiness0000——
Grade 3 Drowsiness0000——
Related Drowsiness0000——
Any Irritability6000——
Grade 3 Irritability0000——
Related Irritability5000——
Any Loss of appetite0000——
Grade 3 Loss of appetite0000——
Related Loss of appetite0000——
Any Fever38311413——
Grade 3 Fever0000——
Related Fever35281313——
SecondaryNumber of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame:
Within the 31-day (Days 0-30) post-primary and post-booster vaccination period
Reported as:
Count of participants · Participants
Number of Subjects With Any Unsolicited Adverse Events (AEs)
ParticipantsTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Any AE(s), post-primary vaccination373432372325
Any AE(s), post-booster vaccination8171812——
SecondaryNumber of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame:
During the entire study period from Month 0 to Month 9
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs)
ParticipantsTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
Number of Subjects With Serious Adverse Events (SAEs)393422

Adverse events

Collected over Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tritanrix-HepB/Hib+Polio Sabin <6S Group1/50 (2%)3/50 (6%)50/50 (100%)
Tritanrix-HepB/Hib+Polio Sabin <6NS Group1/50 (2%)9/50 (18%)49/50 (98%)
Synflorix 7-11S Group1/50 (2%)3/50 (6%)47/50 (94%)
Synflorix 7-11NS Group0/50 (0%)4/50 (8%)47/50 (94%)
Synflorix 12-23S Group0/50 (0%)2/50 (4%)41/50 (82%)
Synflorix 12-23NS Group0/50 (0%)2/50 (4%)31/50 (62%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
GastroenteritisInfections and infestations1/506/501/502/500/501/50
MalariaInfections and infestations3/503/500/501/501/502/50
EnteritisGastrointestinal disorders0/500/500/501/500/500/50
PyrexiaGeneral disorders0/500/501/500/500/500/50
BronchitisInfections and infestations0/500/500/501/500/500/50
Gastroenteritis rotavirusInfections and infestations0/501/500/500/500/500/50
Meningitis salmonellaInfections and infestations1/500/500/500/500/500/50
Osteomyelitis acuteInfections and infestations0/500/500/500/501/500/50
PneumoniaInfections and infestations0/501/500/500/501/500/50
SepsisInfections and infestations1/500/501/500/500/501/50
Most frequent other events
Showing 10 of 16
Most frequent other events
EventTritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS Group
PyrexiaGeneral disorders49/5047/5037/5035/5029/5021/50
PainGeneral disorders23/5026/5015/5015/5014/509/50
MalariaInfections and infestations10/5013/5018/5018/5010/508/50
BronchitisInfections and infestations9/5010/506/509/501/504/50
Sickle cell anaemia with crisisCongenital, familial and genetic disorders1/500/503/500/5010/500/50
IrritabilityPsychiatric disorders9/506/500/500/502/500/50
DiarrhoeaGastrointestinal disorders8/506/504/504/501/501/50
NasopharyngitisInfections and infestations7/505/503/508/504/505/50
EnteritisGastrointestinal disorders2/505/507/504/500/501/50
GastroenteritisInfections and infestations6/506/503/507/501/505/50

Baseline characteristics

Age, Continuous
Age, Continuous(Weeks)Tritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS GroupTotal
Mean8.4 ± 0.98.6 ± 0.98.6 ± 1.58.3 ± 1.216.6 ± 3.316.7 ± 3.511.2 ± 4.4
Sex: Female, Male
Sex: Female, Male(Participants)Tritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS GroupTotal
Female212926321524147
Male292124183526153
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Tritanrix-HepB/Hib+Polio Sabin <6S GroupTritanrix-HepB/Hib+Polio Sabin <6NS GroupSynflorix 7-11S GroupSynflorix 7-11NS GroupSynflorix 12-23S GroupSynflorix 12-23NS GroupTotal
African Heritage/African American505050505050300
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Study locations

1 site
  • GSK Investigational Site
    Ouagadougou, Burkina Faso
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References and documents

Publications

  • Sirima SB, Tiono A, Gansane Z, Siribie M, Zongo A, Ouedraogo A, Francois N, Strezova A, Dobbelaere K, Borys D. Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study. Pediatr Infect Dis J. 2017 May;36(5):e136-e150. doi: 10.1097/INF.0000000000001518. PubMed 28403055 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01175083
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 4, 2010
Start date
Jun 1, 2011
Primary completion
Jan 17, 2013
Completion
May 23, 2013
Results posted
Jun 6, 2019
Last update
Jun 6, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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