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CompletedNCT01746108Updated Jul 9, 2019Results posted

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection

A Phase 3 interventional study of Synflorix™ in Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, sponsored by GlaxoSmithKline. Completed at 6 sites in 2 countries. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
2 Years to 17 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having asplenia, splenic dysfunction or complement deficiencies.

In addition, this study will include an age-matched control group of healthy children aged 24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in the at-risk population to that of the general, healthy population one month after each pneumococcal vaccination.

Read the detailed description

The protocol has been amended to clarify the definition of priming status to consider for inclusion of subjects in the primed groups.

02

Conditions studied

  • Infections, Streptococcal
  • Streptococcus Pneumoniae Vaccines

Keywords

  • Pneumococcal infection
  • Synflorix
  • Children
  • Immunogenicity
  • Safety
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 52 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrollment.
  • Female subjects of non-child bearing potential may be enrolled in the study. (Non-child bearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy).

  • Female subjects of child bearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to the first vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Priming status:

  • Children who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13 will be considered for inclusion in the unprimed groups.

Children who have been previously vaccinated with:

  • at least one dose of a pneumococcal conjugate vaccine, i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13
  • with plain polysaccharide pneumococcal vaccine more than 2 years and less than 5 years before enrollment.
  • will be considered for inclusion in the primed groups.

Additional inclusion criteria for the At-risk groups:

  • A male or female aged between, and including, 2 and 17 years at the time of first vaccination.

  • For the purpose of this study, at-risk subject is a subject with:

    • Congenital or acquired asplenia such as anatomic, surgical or functional asplenia or
    • Splenic dysfunction, chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc or

Note: All individuals who are diagnosed by the investigator as with splenic dysfunction are eligible for enrollment in the At-risk group. When available, investigator will collect medical documentation for reduced splenic function diagnosed with an appropriate technique in the At-risk subject's medical records. No further assessment will be necessary. A maximum of 35 individuals with sickle-cell disease can be enrolled in the At-risk group. These subjects do not require assessment of the splenic function as sickle-cell disease is invariably associated with severe splenic dysfunction.

  • Complement deficiencies. For all subjects defined as At-risk the Investigator will make all efforts to collect information from the subject/subject's parent(s)/LAR(s) during the interview and/or from previously available medical documentation on the date and conditions which have made a child at-risk of pneumococcal infection and/or the results of tests determining spleen dysfunction or complement deficiency. This should be documented in the medical records of the At-risk subject. No originals/copies of medical documentation are needed.

Additional inclusion criteria for the Healthy group:

  • A male or female matched (for age and country) to a subject aged 24-59 months from the At-risk group.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine(s) and ending 30 days after*.

    * In case an emergency mass vaccination for an unforeseen public health threat is organised by the public health authorities, outside the routine immunization program, vaccines can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations and that a written approval of the Sponsor is provided. Vaccines that are recommended for subjects with an increased risk of bacterial infection, can be administered at any time to the subjects enrolled in the At-risk group.

  • 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).
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrollment.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected Human Immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Major congenital defects except medical conditions that define an At-risk subject.
  • Previous vaccination against pneumococcal infection with pneumococcal conjugate vaccine within the last 8 weeks.
  • Previous vaccination against pneumococcal infection with plain polysaccharide vaccine within the last 2 years.

Additional exclusion criteria for the Healthy group:

  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
  • Serious chronic illness.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
05

Study design

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

Study arms

  • Experimental
    At-risk-Unprimed Group

    Subjects who have not been previously vaccinated with any pneumococcal vaccine and are at an increased risk of pneumococcal infection.

    Biological: Synflorix™

  • Experimental
    At-risk-Primed Group

    Subjects who have been previously vaccinated * with at least one dose of a pneumococcal conjugate vaccine i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. * with plain polysaccharide pneumococcal vaccine more than 2 years and less than 5 years before enrollment. and are at an increased risk of pneumococcal infection.

    Biological: Synflorix™

  • Active comparator
    Healthy-Unprimed Group

    Subjects who have not been previously vaccinated with any pneumococcal vaccine and are healthy.

    Biological: Synflorix™

  • Active comparator
    Healthy-Primed Group

    Subjects who have been previously vaccinated with at least one dose of a pneumococcal vaccine and are healthy.

    Biological: Synflorix™

Interventions

  • BiologicalSynflorix™

    1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.

06

What researchers measure

Primary outcomes

  1. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.

    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 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: One month after Dose 1 (At Month 1)

  2. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.

    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 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: One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)

  3. Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.

    Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed 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: One month after Dose 1 (At Month 1)

  4. Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.

    Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed 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: One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)

  5. Concentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.

    Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: One month after Dose 1 (At Month 1)

  6. Concentrations of Antibodies Against Protein D (PD) in the At Risk Unprimed Group.

    Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)

Secondary outcomes

  1. Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.

    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 1

  2. Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.

    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 2

  3. Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.

    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain =Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 1

  4. Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.

    Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 2

  5. Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.

    General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 1

  6. Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.

    General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 2

  7. Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.

    General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 1

  8. Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.

    General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

    Time frame: During the 4-day (Days 0-3) after dose 2

  9. Number of Subjects With Unsolicited AEs.

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

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

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

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of study subjects

    Time frame: From Dose 1 at Month 0 up to study end at Month 1 for primed subjects and at Month 3 for unprimed subjects.

  11. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.

    Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 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: One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)

  12. Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.

    Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed 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. When number of subjects analysed = 1, Lower limit and Upper Limit values were entered as equal to the Geometric mean value. "999999.9" was used as placeholder when Upper Limit value was greater than "1.0E8".

    Time frame: One month after Dose 1 (At Month 1) and/or one month after Dose 2 (At Month 3)

  13. Concentrations of Antibodies Against Protein D (PD) in the Healthy Unprimed Group.

    Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

    Time frame: One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)

07

Results

Posted Jan 9, 2017

Participant flow

No healthy primed subjects were enrolled in the study.

Participant flow — Overall Study
MilestoneSynflorix AR-Pr-2-17Y GroupSynflorix AR-Un-2-17Y GroupSynflorix HE-Un-2-4Y Group
Started18286
Completed18246
Not completed040
Withdrew: Migrated /moved from study area010
Withdrew: Adverse event, non-fatal010
Withdrew: Withdrawal by subject010
Withdrew: Lost to follow-up010

Outcome measures

PrimaryConcentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 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:
One month after Dose 1 (At Month 1)
Reported as:
Geometric mean · μg/mL
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.
μg/mLSynflorix AR-Pr-2-17Y Group
Anti-1 (N=18)1.94 (1.4 to 2.69)
Anti-4 (N=18)6.16 (3.89 to 9.76)
Anti-5 (N=18)2.44 (1.24 to 4.83)
Anti-6B (N=18)3.66 (1.93 to 6.96)
Anti-7F (N=18)3.34 (2.54 to 4.38)
Anti-9V (N=18)2.87 (1.65 to 4.97)
Anti-14 (N=18)21.08 (10.97 to 40.52)
Anti-18C (N=18)10.84 (6.99 to 16.81)
Anti-19F (N=18)18.22 (9.57 to 34.7)
Anti-23F (N=18)2.24 (1.14 to 4.41)
Anti-6A (N=18)3.76 (1.7 to 8.34)
Anti-19A (N=18)4.44 (2.34 to 8.45)
PrimaryConcentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 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:
One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)
Reported as:
Geometric mean · μg/mL
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.
μg/mLSynflorix AR-Un-2-17Y Group
Anti-1 Month 1 (N=23)1.52 (1.13 to 2.06)
Anti-1 Month 3 (N=21)2.52 (1.87 to 3.4)
Anti-4 Month 1 (N=23)9.26 (6.62 to 12.95)
Anti-4 Month 3 (N=21)7.67 (5.59 to 10.53)
Anti-5 Month 1 (N=23)2.74 (1.6 to 4.69)
Anti-5 Month 3 (N=21)3.93 (2.46 to 6.27)
Anti-6B Month 1 (N=23)1.21 (0.59 to 2.46)
Anti-6B Month 3 (N=21)2.19 (1.26 to 3.8)
Anti-7F Month 1 (N=23)3.25 (2.24 to 4.71)
Anti-7F Month 3 (N=21)5.6 (3.95 to 7.93)
Anti-9V Month 1 (N=23)1.89 (1.14 to 3.12)
Anti-9V Month 3 (N=21)3.23 (2.07 to 5.03)
Anti-14 Month 1 (N=23)7.78 (3.86 to 15.68)
Anti-14 Month 3 (N=21)13.64 (8.42 to 22.12)
Anti-18C Month 1 (N=23)13.04 (8.08 to 21.04)
Anti-18C Month 3 (N=21)24.15 (15.4 to 37.86)
Anti-19F Month 1 (N=23)12.41 (6.05 to 25.44)
Anti-19F Month 3 (N=21)20.53 (11.42 to 36.9)
Anti-23F Month 1 (N=23)1.09 (0.5 to 2.4)
Anti-23F Month 3 (N=21)2.26 (1.27 to 4.04)
Anti-6A Month 1 (N=23)1.02 (0.53 to 1.97)
Anti-6A Month 3 (N=21)1.5 (0.87 to 2.58)
Anti-19A Month 1 (N=23)2.18 (0.96 to 4.95)
Anti-19A Month 3 (N=21)4.05 (1.96 to 8.38)
PrimaryOpsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.

Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed 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:
One month after Dose 1 (At Month 1)
Reported as:
Geometric mean · Titers
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.
TitersSynflorix AR-Pr-2-17Y Group
Opsono-1 (N=14)12.4 (5.3 to 29.3)
Opsono-4 (N=15)1291.6 (722.5 to 2308.9)
Opsono-5 (N=15)75.9 (26.9 to 214.2)
Opsono-6B (N=15)698.1 (348.8 to 1397.2)
Opsono-7F (N=15)2787.4 (1959.9 to 3964.4)
Opsono-9V (N=15)1955.3 (1209.8 to 3160.3)
Opsono-14 (N=15)2495.7 (1220.6 to 5103.1)
Opsono-18C (N=15)4421.4 (2982.8 to 6553.9)
Opsono-19F (N=15)3272.4 (1849.4 to 5790.5)
Opsono-23F (N=15)613.8 (244.9 to 1538.5)
Opsono-6A (N=15)2590.9 (1394.2 to 4814.7)
Opsono-19A (N=15)961.2 (376.4 to 2454.8)
PrimaryOpsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.

Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed 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:
One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)
Reported as:
Geometric mean · Titers
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.
TitersSynflorix AR-Un-2-17Y Group
Opsono-1 Month 1 (N=14)8.6 (4 to 18.6)
Opsono-1 Month 3 (N=15)29.1 (12.1 to 70.1)
Opsono-4 Month 1 (N=17)1497.1 (696.6 to 3217.4)
Opsono-4 Month 3 (N=16)2657 (1763.5 to 4003.3)
Opsono-5 Month 1 (N=16)112.5 (49.1 to 258)
Opsono-5 Month 3 (N=16)212.9 (116 to 390.7)
Opsono-6B Month 1 (N=16)1188.8 (548.7 to 2575.7)
Opsono-6B Month 3 (N=16)2384.3 (1483.2 to 3832.8)
Opsono-7F Month 1 (N=17)4433.6 (3110.8 to 6319)
Opsono-7F Month 3 (N=16)6724.3 (4240.9 to 10661.8)
Opsono-9V Month 1 (N=17)1076.5 (330.8 to 3502.8)
Opsono-9V Month 3 (N=16)1319.5 (677.2 to 2571.1)
Opsono-14 Month 1 (N=17)2724.6 (1473.1 to 5039.1)
Opsono-14 Month 3 (N=16)6590.5 (3329.7 to 13044.6)
Opsono-18C Month 1 (N=17)8665.8 (5076.4 to 14793.2)
Opsono-18C Month 3 (N=16)9939.8 (7045 to 14024.1)
Opsono-19F Month 1 (N=16)4569.1 (2695.3 to 7745.5)
Opsono-19F Month 3 (N=16)3441.8 (1709.8 to 6928)
Opsono-23F Month 1 (N=16)1326.4 (796.1 to 2210)
Opsono-23F Month 3 (N=16)1949.3 (1145.5 to 3317.2)
Opsono-6A Month 1 (N=16)1982.6 (648.9 to 6057.2)
Opsono-6A Month 3 (N=14)1908.3 (975.1 to 3734.8)
Opsono-19A Month 1 (N=16)1037.4 (373.5 to 2881.5)
Opsono-19A Month 3 (N=16)2769.3 (1490.6 to 5145)
PrimaryConcentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
One month after Dose 1 (At Month 1)
Reported as:
Geometric mean · EL.U/mL
Concentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.
EL.U/mLSynflorix AR-Pr-2-17Y Group
Concentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.173.1 (109.2 to 274.3)
PrimaryConcentrations of Antibodies Against Protein D (PD) in the At Risk Unprimed Group.

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)
Reported as:
Geometric mean · EL.U/mL
Concentrations of Antibodies Against Protein D (PD) in the At Risk Unprimed Group.
EL.U/mLSynflorix AR-Un-2-17Y Group
Anti-PD Month 1 (N=23)372.5 (179.3 to 773.8)
Anti-PD Month 3 (N=19)870.8 (420.6 to 1803)
SecondaryNumber of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.

Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 1
Reported as:
Number · Subjects
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.
SubjectsSynflorix HE-Un-2-4Y GroupSynflorix AR-PR-2-4Y GroupSynflorix AR-Un-2-4Y Group
Any pain Dose 1512
Grade 3 pain Dose 1100
Any redness Dose 1612
Grade 3 redness Dose 1200
Any swelling Dose 1311
Grade 3 Swelling Dose 1101
SecondaryNumber of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.

Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 2
Reported as:
Number · Subjects
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.
SubjectsSynflorix HE-Un-2-4Y GroupSynflorix AR-Un-2-4Y Group
Any pain Dose 231
Grade 3 pain Dose 210
Any redness Dose 240
Grade 3 Redness Dose 200
Any swelling Dose 211
Grade 3 Swelling Dose 200
SecondaryNumber of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.

Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain =Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 1
Reported as:
Number · Subjects
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.
SubjectsSynflorix AR-PR-5-17Y GroupSynflorix AR- UN-5-17Y Group
Any pain Dose 11422
Grade 3 pain Dose 104
Any redness Dose 1610
Grade 3 redness Dose 100
Any swelling Dose 146
Grade 3 Swelling Dose 110
SecondaryNumber of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.

Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 2
Reported as:
Number · Subjects
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.
SubjectsSynflorix AR- UN-5-17Y Group
Any pain Dose 216
Grade 3 pain Dose 21
Any redness Dose 27
Grade 3 redness Dose 21
Any swelling Dose 25
Grade 3 Swelling Dose 23
SecondaryNumber of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.

General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 1
Reported as:
Number · Subjects
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.
SubjectsSynflorix HE-Un-2-4Y GroupSynflorix AR-PR-2-4Y GroupSynflorix AR-Un-2-4Y Group
Any drowsiness Dose 1110
Grade 3 drowsiness Dose 1000
Related drowsiness Dose 1110
Any irritability Dose 1311
Grade 3 irritability Dose 1000
Related irritability Dose 1311
Any loss of appet Dose 1412
Grade 3 loss of appet. Dose 1000
Related loss of appet. Dose 1311
Any Fever Dose 1101
Grade 3 Fever Dose 1000
Related fever Dose 1100
SecondaryNumber of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.

General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 2
Reported as:
Number · Subjects
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.
SubjectsSynflorix HE-Un-2-4Y GroupSynflorix AR-Un-2-4Y Group
Any drowsiness Dose 211
Grade 3 drowsiness Dose 200
Related drowsiness Dose 211
Any irritability Dose 211
Grade 3 irritability Dose 200
Related irritability Dose 211
Any loss of appet Dose 221
Grade 3 loss of appet. Dose 200
Related loss of appet. Dose 221
Any Fever Dose 201
Grade 3 Fever Dose 200
Related fever Dose 201
SecondaryNumber of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.

General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 1
Reported as:
Number · Subjects
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.
SubjectsSynflorix AR-PR-5-17Y GroupSynflorix AR- UN-5-17Y Group
Any fatigue Dose 155
Grade 3 fatigue Dose 100
Related fatigue Dose 144
Any gastro symp Dose 134
Grade 3 gastro symp. Dose 100
Related gastro symp. Dose 120
Any headache Dose 156
Grade 3 headache Dose 100
Related headache Dose 156
Any Fever Dose 102
Grade 3 Fever Dose 100
Related fever Dose 102
SecondaryNumber of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.

General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever \> 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.

Time frame:
During the 4-day (Days 0-3) after dose 2
Reported as:
Number · Subjects
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.
SubjectsSynflorix AR- UN-5-17Y Group
Any fatigue Dose 27
Grade 3 fatigue Dose 20
Related fatigue Dose 26
Any gastro symp Dose 22
Grade 3 gastro symp. Dose 20
Related gastro symp. Dose 20
Any headache Dose 25
Grade 3 headache Dose 20
Related headache Dose 25
Any Fever Dose 21
Grade 3 Fever Dose 20
Related fever Dose 21
SecondaryNumber of Subjects With Unsolicited AEs.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

Time frame:
Within the 31-day (Days 0-30) post- vaccination period
Reported as:
Number · Subjects
Number of Subjects With Unsolicited AEs.
SubjectsSynflorix AR-Pr-2-17Y GroupSynflorix AR-Un-2-17Y GroupSynflorix HE-Un-2-4Y Group
Number of Subjects With Unsolicited AEs.2144
SecondaryNumber of Subjects With Serious Adverse Events (SAEs).

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of study subjects

Time frame:
From Dose 1 at Month 0 up to study end at Month 1 for primed subjects and at Month 3 for unprimed subjects.
Reported as:
Number · Subjects
Number of Subjects With Serious Adverse Events (SAEs).
SubjectsSynflorix AR-Pr-2-17Y GroupSynflorix AR-Un-2-17Y GroupSynflorix HE-Un-2-4Y Group
Number of Subjects With Serious Adverse Events (SAEs).010
SecondaryConcentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.

Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 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:
One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)
Reported as:
Geometric mean · EL.U/mL
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.
EL.U/mLSynflorix HE-Un-2-4Y Group
Anti-1 Month 1 (N=2)6.09 (0 to 90592008)
Anti-1 Month 3 (N=4)2.41 (0.23 to 25.58)
Anti-4 Month 1 (N=2)10.68 (0.03 to 4390.15)
Anti-4 Month 3 (N=4)10.89 (6.53 to 18.18)
Anti-5 Month 1 (N=2)2.29 (0.62 to 8.41)
Anti-5 Month 3 (N=4)3 (1.2 to 7.53)
Anti-6B Month 1 (N=3)0.52 (0.02 to 16.94)
Anti-6B Month 3 (N=4)0.95 (0.29 to 3.14)
Anti-7F Month 1 (N=3)7.62 (3.05 to 19.01)
Anti-7F Month 3 (N=4)8.4 (2.98 to 23.71)
Anti-9V Month 1 (N=3)2.51 (0.32 to 19.96)
Anti-9V Month 3 (N=4)2.78 (0.77 to 10.01)
Anti-14 Month 1 (N=2)1.44 (0.24 to 8.73)
Anti-14 Month 3 (N=4)7.44 (5.12 to 10.81)
Anti-18C Month 1 (N=3)7.36 (1.99 to 27.26)
Anti-18C Month 3 (N=4)13.72 (2.57 to 73.26)
Anti-19F Month 1 (N=2)20.23 (0.28 to 1466.83)
Anti-19F Month 3 (N=4)12.87 (2.69 to 61.53)
Anti-23F Month 1 (N=2)1.13 (0 to 1209.69)
Anti-23F Month 3 (N=4)1.99 (0.37 to 10.63)
Anti-6A Month 1 (N=2)0.89 (0 to 25368671)
Anti-6A Month 3 (N=4)0.78 (0.26 to 2.29)
Anti-19A Month 1 (N=2)0.1 (0 to 8.09)
Anti-19A Month 3 (N=4)0.53 (0.16 to 1.74)
SecondaryOpsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.

Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed 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. When number of subjects analysed = 1, Lower limit and Upper Limit values were entered as equal to the Geometric mean value. "999999.9" was used as placeholder when Upper Limit value was greater than "1.0E8".

Time frame:
One month after Dose 1 (At Month 1) and/or one month after Dose 2 (At Month 3)
Reported as:
Geometric mean · Titers
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.
TitersSynflorix HE-Un-2-4Y Group
Opsono-1 Month 1 (N=2)35.2 (0 to 999999.9)
Opsono-1 Month 3 (N=2)31.5 (0 to 999999.9)
Opsono-4 Month 1 (N=2)1716.7 (556.1 to 5299.7)
Opsono-4 Month 3 (N=2)3780.1 (0.2 to 62503343)
Opsono-5 Month 3 (N=2)113.3 (0.2 to 61692.5)
Opsono-6B Month 1 (N=2)891.3 (22.4 to 35452)
Opsono-6B Month 3 (N=2)1118.1 (2.3 to 534561.1)
Opsono-7F Month 1 (N=2)4789.2 (28.3 to 810373.3)
Opsono-7F Month 3 (N=2)5269.9 (401.1 to 69232.8)
Opsono-9V Month 1 (N=2)1121 (93.6 to 13432.2)
Opsono-9V Month 3 (N=2)2999.8 (82.6 to 108968.9)
Opsono-14 Month 1 (N=2)1344.9 (0.3 to 5396843)
Opsono-14 Month 3 (N=2)7678.4 (3059.7 to 19269.1)
Opsono-18C Month 1 (N=2)4462 (0.2 to 999999.9)
Opsono-18C Month 3 (N=2)6269.6 (1176.4 to 33412.6)
Opsono-19F Month 1 (N=2)1934.7 (506.3 to 7392.9)
Opsono-19F Month 3 (N=2)1970.4 (250.1 to 15523.1)
Opsono-23F Month 1 (N=2)420.6 (2 to 88878.1)
Opsono-23F Month 3 (N=2)1324.5 (131 to 13391.2)
Opsono-6A Month 1 (N=2)188.8 (0 to 999999.9)
Opsono-6A Month 3 (N=2)2182.1 (1713.7 to 2778.5)
Opsono-19A Month 1 (N=1)4 (4 to 4)
Opsono-19A Month 3 (N=2)637.1 (35.9 to 11317.6)
SecondaryConcentrations of Antibodies Against Protein D (PD) in the Healthy Unprimed Group.

Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.

Time frame:
One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)
Reported as:
Geometric mean · EL.U/mL
Concentrations of Antibodies Against Protein D (PD) in the Healthy Unprimed Group.
EL.U/mLSynflorix HE-Un-2-4Y Group
Anti-PD Month 1 (N=2)217.8 (35.9 to 1320.8)
Anti-PD Month 3 (N=4)373.9 (140.1 to 998.3)

Adverse events

Collected over SAEs: from Month 0 up to Study end, Solicited and Unsolicited AEs: within the 31-day post- vaccination period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Synflorix AR-Pr-2-17Y Group—0/18 (0%)17/18 (94.4%)
Synflorix HE-Un-2-4Y Group—0/6 (0%)6/6 (100%)
Synflorix AR-Un-2-17Y Group—1/28 (3.6%)27/28 (96.4%)
Most frequent serious events
Most frequent serious events
EventSynflorix AR-Pr-2-17Y GroupSynflorix HE-Un-2-4Y GroupSynflorix AR-Un-2-17Y Group
Respiratory tract infectionInfections and infestations0/180/61/28
Most frequent other events
Showing 10 of 17
Most frequent other events
EventSynflorix AR-Pr-2-17Y GroupSynflorix HE-Un-2-4Y GroupSynflorix AR-Un-2-17Y Group
ErythemaSkin and subcutaneous tissue disorders7/186/612/28
PainGeneral disorders15/185/624/28
IrritabilityPsychiatric disorders1/184/61/28
Decreased appetiteMetabolism and nutrition disorders1/184/62/28
SwellingGeneral disorders5/183/610/28
FatigueGeneral disorders5/180/610/28
HeadacheNervous system disorders5/180/67/28
Gastrointestinal disorderGastrointestinal disorders3/180/65/28
SomnolenceNervous system disorders1/181/63/28
Injection site pruritusGeneral disorders0/181/60/28

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Synflorix AR-Pr-2-17Y GroupSynflorix AR-Un-2-17Y GroupSynflorix HE-Un-2-4Y GroupTotal
Mean11.3 ± 3.88.6 ± 4.22.8 ± 0.88.87 ± 4.55
Sex: Female, Male
Sex: Female, Male(Participants)Synflorix AR-Pr-2-17Y GroupSynflorix AR-Un-2-17Y GroupSynflorix HE-Un-2-4Y GroupTotal
Female1014226
Male814426
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Study locations

6 sites
  • GSK Investigational Site
    Krakow, 31-302, Poland
  • GSK Investigational Site
    Warszawa, 02-127, Poland
  • GSK Investigational Site
    Wroclaw, 50-368, Poland
  • GSK Investigational Site
    Barnaul, 656056, Russian Federation
  • GSK Investigational Site
    Novokuznetsk, 654063, Russian Federation
  • GSK Investigational Site
    St Petersburg, 197022, Russian Federation
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References and documents

Publications

  • Szenborn L, Osipova IV, Czajka H, Kharit SM, Jackowska T, Francois N, Habib MA, Borys D. Immunogenicity, safety and reactogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in 2-17-year-old children with asplenia or splenic dysfunction: A phase 3 study. Vaccine. 2017 Sep 25;35(40):5331-5338. doi: 10.1016/j.vaccine.2017.08.039. Epub 2017 Aug 31. PubMed 28866290 ↗

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 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
NCT01746108
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 10, 2012
Start date
Jun 18, 2013
Primary completion
Jun 29, 2015
Completion
Jun 29, 2015
Results posted
Jan 9, 2017
Last update
Jul 9, 2019

Study contacts

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

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