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CompletedNCT03197376Updated Jul 14, 2020Results posted

Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants

A Phase 3 interventional study of Pneumosil and Synflorix in Pneumonia, Pneumococcal, sponsored by PATH. Completed at 1 site in Gambia. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by PATH · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,250
Allocation
Randomized
Ages
6 Weeks to 8 Weeks
Sex
All
01

Study summary

This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at the immune response in infants. In addition, the study will compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.

Read the detailed description

This is a randomized, active-controlled, double-blind, Phase 3 study in 2,250 healthy infants (6 to 8 weeks of age). Subjects will receive 3 doses of either PNEUMOSIL (3 groups receiving vaccine from different lots) or Synflorix (1 group) at 6, 10, and 14 weeks of age. The first 675 randomized subjects will receive a booster dose of either PNEUMOSIL or Synflorix at 9 months of age that matches the treatment assignment for the priming phase. Standard EPI vaccinations in The Gambia will be given concomitantly with all 4 doses of the study vaccines. Out of the 675 booster subjects, subjects who consented for further evaluation will participate for the assessment of immune persistence 12 (+1) months after the booster vaccination

The primary objectives are to demonstrate that the three lots of the Pneumosil vaccine is consistent by evaluating the immune responses, and to demonstrate that the immune responses generated by Pneumosil are non-inferior to those generated by Synflorix. The safety and tolerability of Pneumosil will also be evaluated.

02

Conditions studied

  • Pneumonia, Pneumococcal
03

Who can participate

Ages eligible
6 Weeks to 8 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • They are healthy infants based on medical history and clinical assessment.
  • They are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive.
  • Subject's parent must provide voluntary written/thumb-printed informed consent and be willing to comply with study requirements and procedures.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational medicinal product prior to randomization.
  • Previous vaccination against or infection with S. pneumoniae.
  • History of anaphylactic shock or an allergic reaction to any prior vaccination.
  • Any fever, illness (including malaria).
  • Receipt of another vaccine within 30 days of study start.
  • Chronic administration of an immunosuppressant or administration of immunoglobulins
  • History of blood disorder, primary immunodeficiency, or a sibling who has such a diagnosis or who died of suddenly without apparent cause.
  • History of meningitis, seizures or any neurological disorder.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,250 participants (actual)

Study arms

  • Experimental
    Pneumosil Lot 1

    Pneumosil Lot 1

    Biological: Pneumosil

  • Experimental
    Pneumosil Lot 2

    Pneumosil Lot 2

    Biological: Pneumosil

  • Experimental
    Pneumosil Lot 3

    Pneumosil Lot 3

    Biological: Pneumosil

  • Active comparator
    Synflorix

    Synflorix

    Biological: Synflorix

Interventions

  • BiologicalPneumosil

    10-Valent Pneumococcal Conjugate Vaccine

  • BiologicalSynflorix

    Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed

05

What researchers measure

Primary outcomes

  1. Serotype-specific Geometric Mean Concentration of IgG Antibody

    Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA

    Time frame: 4 weeks after the third dose

  2. Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL

    Number and Percentage of subjects with serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL

    Time frame: 4 weeks after the third dose

  3. Serotype-specific Geometric Mean Concentration of IgG Antibody

    Serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC) 4 weeks after the primary series of PNEUMOSIL/Synflorix co-administered with pentavalent, RV and polio vaccines.

    Time frame: 4 weeks after the third dose

  4. Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)

    Subjects with 1) anti-diphtheria toxoid (DT) and anti-tetanus toxoid (DT) IgG concentration ≥ 0.1 IU/mL; 2) anti-Hepatitis B surface antigen (HBsAg) IgG concentration ≥ 10 mIU/mL; 3) anti-Hib (polyribosylribitol phosphate \[PRP\]) IgG concentration ≥ 0.15 µg/mL; 4) anti-poliovirus types 1, 2 and 3 neutralizing antibody titers ≥ 1:8; 5) anti-rotavirus IgA concentration ≥ 20 U/mL.

    Time frame: 4 weeks after the third dose

  5. Anti-pertussis Toxoid GMCs for the Pertussis Antigen

    Anti-pertussis toxoid GMCs for the pertussis antigen

    Time frame: 4 weeks after the third dose

  6. Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen

    Anti fimbriae 2/3 IgG GMCs for the pertussis antigen

    Time frame: 4 weeks after the third dose

  7. Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1

    In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

    Time frame: 7 days (including day of vaccination)

  8. Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2

    In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

    Time frame: 7 days (including day of vaccination)

  9. Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3

    In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

    Time frame: 7 days (including day of vaccination)

  10. Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster

    In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

    Time frame: 7 days (including day of vaccination)

  11. Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness

    All subjects were followed up for AEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for AEs till 4 weeks post booster vaccination

    Time frame: 4 weeks post last vaccination

  12. Number and Percentage of All SAEs by Severity and Relatedness

    All subjects were followed up for SAEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for SAEs till 4 weeks post booster vaccination

    Time frame: 4 weeks post last vaccination

Secondary outcomes

  1. Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody

    Subjects with 6A and 19A serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA

    Time frame: 4 weeks after the third dose

  2. 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody

    6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA

    Time frame: 4 weeks after the third dose

  3. Number and Percentage of Subjects With Functional Antibody Responses

    Serotype-specific functional antibody titer measured by OPA

    Time frame: 4 weeks after the third dose

  4. Serotype-specific OPA Geometric Mean Titer

    Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset

    Time frame: 4 weeks after the third dose

  5. Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose

    Comparison of Serotype-specific booster responses (antibody concentrations) measured by ELISA from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose

    Time frame: 4 weeks post booster vaccination

  6. Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose

    Comparison of Serotype-specific booster responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose

    Time frame: 4 weeks post booster vaccination

  7. Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose

    Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose

    Time frame: 4 weeks post booster vaccination

  8. Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose

    Comparison of Serotype-specific booster responses (functional response) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose

    Time frame: 4 weeks post booster vaccination

  9. Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)

    Anti-measles IgG, anti-rubella IgG and anti-yellow fever neutralizing antibody titer

    Time frame: 4 weeks post booster vaccination

Other outcomes

  1. Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster

    Treatment group proportions and treatment-group difference in proportions of IgG responders (IgG concentration ≥ 0.35 μg/mL)

    Time frame: One Year Post Booster Vaccination

  2. Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster

    Comparison of Serotype-specific immune persistence responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix one year post booster

    Time frame: One year post booster vaccination

  3. Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose

    Comparison of Serotype-specific responses (antibody concentrations) measured by ELISA from 4 weeks after a booster dose to one year after a booster dose

    Time frame: One year post booster vaccination

  4. Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster

    Serotype-specific functional antibody titer measured by OPA

    Time frame: One year post booster vaccination

  5. Serotype-specific OPA Geometric Mean Titer One Year Post Booster

    Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset one year post booster

    Time frame: One year post booster vaccination

  6. Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose

    Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a booster dose to one year post booster

    Time frame: One year post booster vaccination

06

Results

Posted Sep 11, 2019

Participant flow

Recruitment period: 21 June 2017 to 29 January 2018

Primary and Booster Phase
Participant flow — Primary and Booster Phase
MilestonePneumosil Lot 1Pneumosil Lot 2Pneumosil Lot 3Synflorix
Started502501500747
Vaccinated-dose 1502501500747
Vaccinated-dose 2495495491738
Vaccinated-dose 3492493490731
Primary reactogenicity cohort251243257364
Booster cohort150151150224
Received booster vaccine145144139213
Completed487488480722
Not completed15132025
Withdrew: Adverse event0001
Withdrew: Death1002
Withdrew: Lost to follow-up0010
Withdrew: Physician decision1013
Withdrew: Withdrawal by subject's parents11101411
Withdrew: Ineligibility criteria1142
Withdrew: Not vaccine related1206
Immune Persistence Phase
Participant flow — Immune Persistence Phase
MilestonePneumosil Lot 1Pneumosil Lot 2Pneumosil Lot 3Synflorix
Started132133128195
Completed127129123190
Not completed5455
Withdrew: Lost to follow-up0021
Withdrew: Withdrawal by subject's parents4423
Withdrew: Not vaccine related1011

Outcome measures

PrimarySerotype-specific Geometric Mean Concentration of IgG Antibody

Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA

Time frame:
4 weeks after the third dose
Reported as:
Geometric mean · µg/mL
Serotype-specific Geometric Mean Concentration of IgG Antibody
µg/mLLot 1Lot 2Lot 3
Pn IgG Type 14.08 (3.84 to 4.33)4.24 (3.97 to 4.52)4.58 (4.30 to 4.87)
Pn IgG Type 51.34 (1.27 to 1.43)1.80 (1.70 to 1.91)1.84 (1.73 to 1.96)
Pn IgG Type 6A1.05 (0.95 to 1.15)0.95 (0.86 to 1.06)1.01 (0.91 to 1.11)
Pn IgG Type 6B1.30 (1.15 to 1.47)0.92 (0.81 to 1.05)1.49 (1.32 to 1.68)
Pn IgG Type 7F2.79 (2.61 to 2.98)2.55 (2.37 to 2.75)3.70 (3.46 to 3.96)
Pn IgG Type 9V1.28 (1.20 to 1.37)1.19 (1.11 to 1.28)1.46 (1.36 to 1.56)
Pn IgG Type 144.99 (4.52 to 5.51)5.37 (4.87 to 5.92)5.25 (4.78 to 5.76)
Pn IgG Type 19A1.53 (1.42 to 1.66)1.66 (1.53 to 1.79)1.74 (1.61 to 1.88)
Pn IgG Type 19F4.20 (3.92 to 4.50)5.02 (4.68 to 5.39)3.89 (3.59 to 4.21)
Pn IgG Type 23F1.61 (1.48 to 1.74)1.57 (1.44 to 1.72)1.56 (1.44 to 1.70)
Statistical analysis
  • Lot 1 vs Lot 2 · Pn igg type 1 gmc ratio: 0.96 · 95% CI 0.88 to 1.05
  • Lot 1 vs Lot 2 · Pn igg type 5 gmc ratio: 0.75 · 95% CI 0.69 to 0.81
  • Lot 1 vs Lot 2 · Pn igg type 6a gmc ratio: 1.1 · 95% CI 0.96 to 1.26
  • Lot 1 vs Lot 2 · Pn igg type 6b gmc ratio: 1.41 · 95% CI 1.18 to 1.69
  • Lot 1 vs Lot 2 · Pn igg type 7f gmc ratio: 1.09 · 95% CI 0.99 to 1.20
  • Lot 1 vs Lot 2 · Pn igg type 9v gmc ratio: 1.08 · 95% CI 0.98 to 1.18
  • Lot 1 vs Lot 2 · Pn igg type 14 gmc ratio: 0.93 · 95% CI 0.81 to 1.07
  • Lot 1 vs Lot 2 · Pn igg type 19a gmc ratio: 0.93 · 95% CI 0.83 to 1.04
  • Lot 1 vs Lot 2 · Pn igg type 19f gmc ratio: 0.84 · 95% CI 0.76 to 0.92
  • Lot 1 vs Lot 2 · Pn igg type 23f gmc ratio: 1.02 · 95% CI 0.91 to 1.15
  • Lot 1 vs Lot 3 · Pn igg type 1 gmc ratio: 0.89 · 95% CI 0.82 to 0.97
  • Lot 1 vs Lot 3 · Pn igg type 5 gmc ratio: 0.73 · 95% CI 0.67 to 0.80
  • Lot 1 vs Lot 3 · Pn igg type 6a gmc ratio: 1.04 · 95% CI 0.91 to 1.20
  • Lot 1 vs Lot 3 · Pn igg type 6b gmc ratio: 0.87 · 95% CI 0.74 to 1.04
  • Lot 1 vs Lot 3 · Pn igg type 7f gmc ratio: 0.75 · 95% CI 0.68 to 0.83
  • Lot 1 vs Lot 3 · Pn igg type 9v gmc ratio: 0.88 · 95% CI 0.80 to 0.97
  • Lot 1 vs Lot 3 · Pn igg type 14 gmc ratio: 0.95 · 95% CI 0.83 to 1.09
  • Lot 1 vs Lot 3 · Pn igg type 19a gmc ratio: 0.88 · 95% CI 0.79 to 0.98
  • Lot 1 vs Lot 3 · Pn igg type 19f gmc ratio: 1.08 · 95% CI 0.97 to 1.20
  • Lot 1 vs Lot 3 · Pn igg type 23f gmc ratio: 1.03 · 95% CI 0.92 to 1.15
  • Lot 2 vs Lot 3 · Pn igg type 1 gmc ratio: 0.93 · 95% CI 0.85 to 1.01
  • Lot 2 vs Lot 3 · Pn igg type 5 gmc ratio: 0.98 · 95% CI 0.90 to 1.07
  • Lot 2 vs Lot 3 · Pn igg type 6a gmc ratio: 0.95 · 95% CI 0.82 to 1.09
  • Lot 2 vs Lot 3 · Pn igg type 6b gmc ratio: 0.62 · 95% CI 0.52 to 0.74
  • Lot 2 vs Lot 3 · Pn igg type 7f gmc ratio: 0.69 · 95% CI 0.62 to 0.76
  • Lot 2 vs Lot 3 · Pn igg type 9v gmc ratio: 0.82 · 95% CI 0.74 to 0.90
  • Lot 2 vs Lot 3 · Pn igg type 14 gmc ratio: 1.02 · 95% CI 0.89 to 1.17
  • Lot 2 vs Lot 3 · Pn igg type 19a gmc ratio: 0.95 · 95% CI 0.85 to 1.06
  • Lot 2 vs Lot 3 · Pn igg type 19f gmc ratio: 1.29 · 95% CI 1.16 to 1.44
  • Lot 2 vs Lot 3 · Pn igg type 23f gmc ratio: 1.00 · 95% CI 0.89 to 1.13
PrimaryNumber and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL

Number and Percentage of subjects with serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL

Time frame:
4 weeks after the third dose
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
ParticipantsPneumosilSynflorix
Pn IgG Type 11454717
Pn IgG Type 51435692
Pn IgG Type 6A1193555
Pn IgG Type 6B1142555
Pn IgG Type 7F1443709
Pn IgG Type 9V1391690
Pn IgG Type 141437715
Pn IgG Type 19A1386555
Pn IgG Type 19F1427713
Pn IgG Type 23F1372557
Statistical analysis
  • Pneumosil vs Synflorix · Absolute difference for type 1: 0.7 · 97.5% CI -0.0 to 1.9
  • Pneumosil vs Synflorix · Absolute difference for type 5: 2.8 · 97.5% CI 1.2 to 5.0
  • Pneumosil vs Synflorix · Absolute difference for type 6a: 5.2 · 97.5% CI 1.1 to 9.5
  • Pneumosil vs Synflorix · Absolute difference for type 6b: 2.0 · 97.5% CI -2.2 to 6.4
  • Pneumosil vs Synflorix · Absolute difference for type 7f: 1.0 · 97.5% CI -0.1 to 2.7
  • Pneumosil vs Synflorix · Absolute difference for type 9v: 0.1 · 97.5% CI -1.9 to 2.5
  • Pneumosil vs Synflorix · Absolute difference for type 14: -0.3 · 97.5% CI -1.4 to 1.0
  • Pneumosil vs Synflorix · Absolute difference for type 19a: 18.7 · 97.5% CI 15.1 to 22.5
  • Pneumosil vs Synflorix · Absolute difference for type 19f: -0.8 · 97.5% CI -1.9 to 0.5
  • Pneumosil vs Synflorix · Absolute difference for type 23f: 17.2 · 97.5% CI 13.6 to 21.1
PrimarySerotype-specific Geometric Mean Concentration of IgG Antibody

Serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC) 4 weeks after the primary series of PNEUMOSIL/Synflorix co-administered with pentavalent, RV and polio vaccines.

Time frame:
4 weeks after the third dose
Reported as:
Geometric mean · µg/mL
Serotype-specific Geometric Mean Concentration of IgG Antibody
µg/mLPneumosilSynflorix
Pn IgG Type 14.29 (4.14 to 4.45)1.99 (1.88 to 2.11)
Pn IgG Type 51.65 (1.59 to 1.71)1.20 (1.14 to 1.26)
Pn IgG Type 6A1.00 (0.95 to 1.06)1.13 (1.02 to 1.25)
Pn IgG Type 6B1.21 (1.13 to 1.30)1.13 (1.02 to 1.25)
Pn IgG Type 7F2.97 (2.85 to 3.10)2.29 (2.16 to 2.43)
Pn IgG Type 9V1.31 (1.26 to 1.36)1.42 (1.34 to 1.50)
Pn IgG Type 145.20 (4.92 to 5.50)4.24 (3.90 to 4.61)
Pn IgG Type 19A1.64 (1.57 to 1.72)1.13 (1.02 to 1.25)
Pn IgG Type 19F4.35 (4.17 to 4.54)5.93 (5.50 to 6.39)
Pn IgG Type 23F1.58 (1.51 to 1.66)0.87 (0.80 to 0.95)
Statistical analysis
  • Pneumosil vs Synflorix · Pn igg type 1 gmc ratio: 2.15 · 97.5% CI 2.00 to 2.32
  • Pneumosil vs Synflorix · Pn igg type 5 gmc ratio: 1.37 · 97.5% CI 1.28 to 1.47
  • Pneumosil vs Synflorix · Pn igg type 6a gmc ratio: 0.89 · 97.5% CI 0.78 to 1.01
  • Pneumosil vs Synflorix · Pn igg type 6b gmc ratio: 1.07 · 97.5% CI 0.93 to 1.24
  • Pneumosil vs Synflorix · Pn igg type 7f gmc ratio: 1.30 · 97.5% CI 1.19 to 1.41
  • Pneumosil vs Synflorix · Pn igg type 9v gmc ratio: 0.92 · 97.5% CI 0.85 to 1.00
  • Pneumosil vs Synflorix · Pn igg type 14 gmc ratio: 1.23 · 97.5% CI 1.10 to 1.37
  • Pneumosil vs Synflorix · Pn igg type 19a gmc ratio: 1.45 · 97.5% CI 1.30 to 1.63
  • Pneumosil vs Synflorix · Pn igg type 19f gmc ratio: 0.73 · 97.5% CI 0.67 to 0.80
  • Pneumosil vs Synflorix · Pn igg type 23f gmc ratio: 1.81 · 97.5% CI 1.63 to 2.01
PrimaryNumber and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)

Subjects with 1) anti-diphtheria toxoid (DT) and anti-tetanus toxoid (DT) IgG concentration ≥ 0.1 IU/mL; 2) anti-Hepatitis B surface antigen (HBsAg) IgG concentration ≥ 10 mIU/mL; 3) anti-Hib (polyribosylribitol phosphate \[PRP\]) IgG concentration ≥ 0.15 µg/mL; 4) anti-poliovirus types 1, 2 and 3 neutralizing antibody titers ≥ 1:8; 5) anti-rotavirus IgA concentration ≥ 20 U/mL.

Time frame:
4 weeks after the third dose
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
ParticipantsPneumosilSynflorix
Anti-Diphtheria Toxoid ≥ 0.1 IU/mL447225
Anti-Tetanus Toxoid ≥ 0.1 IU/mL447225
Anti-HBsAg concentration ≥ 10 mIU/mL447224
Anti-PRP concentration ≥ 0.15 μg/mL441224
Anti-Polio titer ≥ 1:8 (type 1)446225
Anti-Polio titer ≥ 1:8 (type 2)374182
Anti-Polio titer ≥ 1:8 (type 3)437222
Anti-Rotavirus concentration ≥ 20 U/mL12261
Statistical analysis
  • Pneumosil vs Synflorix · Absolute difference for diphtheria: 0.0CI could not be computed due to 100% response rate
  • Pneumosil vs Synflorix · Absolute difference for tetanus: 0.0CI could not be computed due to 100% response rate
  • Pneumosil vs Synflorix · Absolute difference for hepatitis b: 0.4 · 95% CI -0.4 to 2.5
  • Pneumosil vs Synflorix · Absolute difference for hib: -0.9 · 95% CI -2.5 to 1.2
  • Pneumosil vs Synflorix · Absolute difference for polio type 1: -0.2 · 95% CI -1.3 to 1.5
  • Pneumosil vs Synflorix · Absolute difference for polio type 2: 2.8 · 95% CI -3.2 to 9.3
  • Pneumosil vs Synflorix · Absolute difference for polio type 3: -0.9 · 95% CI -3.0 to 1.8
  • Pneumosil vs Synflorix · Absolute difference for rotavirus: 0.2 · 95% CI -7.1 to 7.1
PrimaryAnti-pertussis Toxoid GMCs for the Pertussis Antigen

Anti-pertussis toxoid GMCs for the pertussis antigen

Time frame:
4 weeks after the third dose
Reported as:
Geometric mean · IU/mL
Anti-pertussis Toxoid GMCs for the Pertussis Antigen
IU/mLPneumosilSynflorix
Anti-pertussis Toxoid GMCs for the Pertussis Antigen50.95 (43.13 to 60.20)61.82 (49.58 to 77.09)
Statistical analysis
  • Pneumosil vs Synflorix · Gmc ratio for anti-pertussis toxoid: 0.82 · 95% CI 0.62 to 1.09
PrimaryAnti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen

Anti fimbriae 2/3 IgG GMCs for the pertussis antigen

Time frame:
4 weeks after the third dose
Reported as:
Geometric mean · U/mL
Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen
U/mLPneumosilSynflorix
Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen317.97 (275.91 to 366.45)324.87 (267.34 to 394.78)
Statistical analysis
  • Pneumosil vs Synflorix · Gmc ratio for anti-fimbriae 2/3: 0.98 · 95% CI 0.77 to 1.25
PrimaryNumber and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1

In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

Time frame:
7 days (including day of vaccination)
Reported as:
Count of participants · Participants
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
ParticipantsPneumosilSynflorix
Temperature — Grade 0516249
Temperature — Grade 118388
Temperature — Grade 25227
Cutaneous Rash — Grade 0731353
Cutaneous Rash — Grade 11910
Cutaneous Rash — Grade 211
Irritability — Grade 0619301
Irritability — Grade 112757
Irritability — Grade 256
Drowsiness — Grade 0732352
Drowsiness — Grade 11912
Drowsiness — Grade 200
Decreased Appetite — Grade 0728349
Decreased Appetite — Grade 12212
Decreased Appetite — Grade 213
Tenderness — Grade 0539251
Tenderness — Grade 118593
Tenderness — Grade 22720
Erythema/Redness — Grade 0736350
Erythema/Redness — Grade 11513
Erythema/Redness — Grade 201
Induration/Swelling — Grade 0731345
Induration/Swelling — Grade 11716
Induration/Swelling — Grade 233
PrimaryNumber and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2

In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

Time frame:
7 days (including day of vaccination)
Reported as:
Count of participants · Participants
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
ParticipantsPneumosilSynflorix
Temperature — Grade 0590271
Temperature — Grade 112170
Temperature — Grade 22519
Temperature — Grade 331
Cutaneous Rash — Grade 0727355
Cutaneous Rash — Grade 1104
Cutaneous Rash — Grade 221
Cutaneous Rash — Grade 301
Irritability — Grade 0646324
Irritability — Grade 18436
Irritability — Grade 281
Irritability — Grade 310
Drowsiness — Grade 0726359
Drowsiness — Grade 1132
Drowsiness — Grade 200
Drowsiness — Grade 300
Decreased Appetite — Grade 0728354
Decreased Appetite — Grade 1104
Decreased Appetite — Grade 203
Decreased Appetite — Grade 310
Tenderness — Grade 0585283
Tenderness — Grade 112763
Tenderness — Grade 22715
Tenderness — Grade 300
Erythema/Redness — Grade 0725356
Erythema/Redness — Grade 1145
Erythema/Redness — Grade 200
Erythema/Redness — Grade 300
Induration/Swelling — Grade 0724348
Induration/Swelling — Grade 11411
Induration/Swelling — Grade 212
Induration/Swelling — Grade 300
PrimaryNumber and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3

In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

Time frame:
7 days (including day of vaccination)
Reported as:
Count of participants · Participants
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
ParticipantsPneumosilSynflorix
Temperature — Grade 0576301
Temperature — Grade 112251
Temperature — Grade 2377
Temperature — Grade 301
Temperature — Grade 400
Cutaneous Rash — Grade 0726358
Cutaneous Rash — Grade 192
Cutaneous Rash — Grade 200
Cutaneous Rash — Grade 300
Cutaneous Rash — Grade 400
Irritability — Grade 0657316
Irritability — Grade 17441
Irritability — Grade 233
Irritability — Grade 300
Irritability — Grade 410
Drowsiness — Grade 0717352
Drowsiness — Grade 1178
Drowsiness — Grade 200
Drowsiness — Grade 310
Drowsiness — Grade 400
Decreased Appetite — Grade 0716353
Decreased Appetite — Grade 1176
Decreased Appetite — Grade 210
Decreased Appetite — Grade 311
Decreased Appetite — Grade 400
Tenderness — Grade 0605296
Tenderness — Grade 111055
Tenderness — Grade 2209
Tenderness — Grade 300
Tenderness — Grade 400
Erythema/Redness — Grade 0730357
Erythema/Redness — Grade 143
Erythema/Redness — Grade 210
Erythema/Redness — Grade 300
Erythema/Redness — Grade 400
Induration/Swelling — Grade 0727353
Induration/Swelling — Grade 176
Induration/Swelling — Grade 211
Induration/Swelling — Grade 300
Induration/Swelling — Grade 400
PrimaryNumber and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster

In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].

Time frame:
7 days (including day of vaccination)
Reported as:
Count of participants · Participants
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
ParticipantsPneumosilSynflorix
Temperature — Grade 0404197
Temperature — Grade 11412
Temperature — Grade 294
Temperature — Grade 310
Cutaneous Rash — Grade 0424211
Cutaneous Rash — Grade 142
Cutaneous Rash — Grade 200
Cutaneous Rash — Grade 300
Irritability — Grade 0415207
Irritability — Grade 1126
Irritability — Grade 210
Irritability — Grade 300
Drowsiness — Grade 0418208
Drowsiness — Grade 195
Drowsiness — Grade 200
Drowsiness — Grade 310
Decreased Appetite — Grade 0425211
Decreased Appetite — Grade 122
Decreased Appetite — Grade 210
Decreased Appetite — Grade 300
Tenderness — Grade 0395200
Tenderness — Grade 1289
Tenderness — Grade 254
Tenderness — Grade 300
Erythema/Redness — Grade 0428213
Erythema/Redness — Grade 100
Erythema/Redness — Grade 200
Erythema/Redness — Grade 300
Induration/Swelling — Grade 0423209
Induration/Swelling — Grade 154
Induration/Swelling — Grade 200
Induration/Swelling — Grade 300
PrimaryNumber and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness

All subjects were followed up for AEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for AEs till 4 weeks post booster vaccination

Time frame:
4 weeks post last vaccination
Reported as:
Count of participants · Participants
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
ParticipantsPneumosilSynflorix
Upper respiratory tract infection — Mild-Related00
Upper respiratory tract infection — Mild-Not related714366
Upper respiratory tract infection — Moderate-Related00
Upper respiratory tract infection — Moderate-Not related4826
Upper respiratory tract infection — Severe-Related00
Upper respiratory tract infection — Severe-Not related20
Upper respiratory tract infection — None739355
Furuncle — Mild-Related00
Furuncle — Mild-Not related14262
Furuncle — Moderate-Related00
Furuncle — Moderate-Not related113
Furuncle — Severe-Related00
Furuncle — Severe-Not related00
Furuncle — None1350682
Gastroenteritis — Mild-Related00
Gastroenteritis — Mild-Not related12567
Gastroenteritis — Moderate-Related00
Gastroenteritis — Moderate-Not related277
Gastroenteritis — Severe-Related00
Gastroenteritis — Severe-Not related53
Gastroenteritis — None1346670
Conjunctivitis — Mild-Related00
Conjunctivitis — Mild-Not related10362
Conjunctivitis — Moderate-Related00
Conjunctivitis — Moderate-Not related82
Conjunctivitis — Severe-Related00
Conjunctivitis — Severe-Not related00
Conjunctivitis — None1392683
Bronchiolitis — Mild-Related00
Bronchiolitis — Mild-Not related3032
Bronchiolitis — Moderate-Related00
Bronchiolitis — Moderate-Not related208
Bronchiolitis — Severe-Related00
Bronchiolitis — Severe-Not related134
Bronchiolitis — None1440703
Tinea infection — Mild-Related00
Tinea infection — Mild-Not related5921
Tinea infection — Moderate-Related00
Tinea infection — Moderate-Not related31
Tinea infection — Severe-Related00
Tinea infection — Severe-Not related00
Tinea infection — None1441725
Febrile infection — Mild-Related00
Febrile infection — Mild-Not related4420
Febrile infection — Moderate-Related00
Febrile infection — Moderate-Not related97
Febrile infection — Severe-Related00
Febrile infection — Severe-Not related01
Febrile infection — None1450719
Pneumonia — Mild-Related00
Pneumonia — Mild-Not related1710
Pneumonia — Moderate-Related00
Pneumonia — Moderate-Not related215
Pneumonia — Severe-Related00
Pneumonia — Severe-Not related56
Pneumonia — None1460726
Tinea capitis — Mild-Related00
Tinea capitis — Mild-Not related2922
Tinea capitis — Moderate-Related00
Tinea capitis — Moderate-Not related00
Tinea capitis — Severe-Related00
Tinea capitis — Severe-Not related00
Tinea capitis — None1474725
Oral candidiasis — Mild-Related00
Oral candidiasis — Mild-Not related3115
Oral candidiasis — Moderate-Related00
Oral candidiasis — Moderate-Not related40
Oral candidiasis — Severe-Related00
Oral candidiasis — Severe-Not related00
Oral candidiasis — None1468732
Body tinea — Mild-Related00
Body tinea — Mild-Not related2718
Body tinea — Moderate-Related00
Body tinea — Moderate-Not related20
Body tinea — Severe-Related00
Body tinea — Severe-Not related00
Body tinea — None1474729
Impetigo — Mild-Related00
Impetigo — Mild-Not related2419
Impetigo — Moderate-Related00
Impetigo — Moderate-Not related30
Impetigo — Severe-Related00
Impetigo — Severe-Not related00
Impetigo — None1476728
Rash pustular — Mild-Related00
Rash pustular — Mild-Not related2515
Rash pustular — Moderate-Related00
Rash pustular — Moderate-Not related01
Rash pustular — Severe-Related00
Rash pustular — Severe-Not related00
Rash pustular — None1478731
Skin candida — Mild-Related00
Skin candida — Mild-Not related1411
Skin candida — Moderate-Related00
Skin candida — Moderate-Not related00
Skin candida — Severe-Related00
Skin candida — Severe-Not related00
Skin candida — None1489736
Diarrhoea — Mild-Related10
Diarrhoea — Mild-Not related268130
Diarrhoea — Moderate-Related00
Diarrhoea — Moderate-Not related163
Diarrhoea — Severe-Related00
Diarrhoea — Severe-Not related00
Diarrhoea — None1218614
Vomiting — Mild-Related01
Vomiting — Mild-Not related2212
Vomiting — Moderate-Related00
Vomiting — Moderate-Not related20
Vomiting — Severe-Related00
Vomiting — Severe-Not related10
Vomiting — None1478734
Dermatitis diaper — Mild-Related00
Dermatitis diaper — Mild-Not related3427
Dermatitis diaper — Moderate-Related00
Dermatitis diaper — Moderate-Not related21
Dermatitis diaper — Severe-Related00
Dermatitis diaper — Severe-Not related00
Dermatitis diaper — None1467719
Rash maculo-papular — Mild-Related01
Rash maculo-papular — Mild-Not related3714
Rash maculo-papular — Moderate-Related00
Rash maculo-papular — Moderate-Not related02
Rash maculo-papular — Severe-Related00
Rash maculo-papular — Severe-Not related00
Rash maculo-papular — None1466730
Rash papular — Mild-Related10
Rash papular — Mild-Not related1911
Rash papular — Moderate-Related00
Rash papular — Moderate-Not related00
Rash papular — Severe-Related00
Rash papular — Severe-Not related00
Rash papular — None1483736
Dermatitis contact — Mild-Related00
Dermatitis contact — Mild-Not related167
Dermatitis contact — Moderate-Related00
Dermatitis contact — Moderate-Not related20
Dermatitis contact — Severe-Related00
Dermatitis contact — Severe-Not related00
Dermatitis contact — None1485740
Dermatitis atopic — Mild-Related00
Dermatitis atopic — Mild-Not related1210
Dermatitis atopic — Moderate-Related00
Dermatitis atopic — Moderate-Not related01
Dermatitis atopic — Severe-Related00
Dermatitis atopic — Severe-Not related00
Dermatitis atopic — None1491736
Seborrhoeic dermatitis — Mild-Related00
Seborrhoeic dermatitis — Mild-Not related165
Seborrhoeic dermatitis — Moderate-Related00
Seborrhoeic dermatitis — Moderate-Not related10
Seborrhoeic dermatitis — Severe-Related00
Seborrhoeic dermatitis — Severe-Not related00
Seborrhoeic dermatitis — None1486742
Cough — Mild-Related00
Cough — Mild-Not related9538
Cough — Moderate-Related00
Cough — Moderate-Not related01
Cough — Severe-Related00
Cough — Severe-Not related00
Cough — None1408708
Pyrexia — Mild-Related10
Pyrexia — Mild-Not related1715
Pyrexia — Moderate-Related10
Pyrexia — Moderate-Not related81
Pyrexia — Severe-Related30
Pyrexia — Severe-Not related10
Pyrexia — None1472731
Thermal burn — Mild-Related00
Thermal burn — Mild-Not related710
Thermal burn — Moderate-Related00
Thermal burn — Moderate-Not related21
Thermal burn — Severe-Related00
Thermal burn — Severe-Not related00
Thermal burn — None1494736
PrimaryNumber and Percentage of All SAEs by Severity and Relatedness

All subjects were followed up for SAEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for SAEs till 4 weeks post booster vaccination

Time frame:
4 weeks post last vaccination
Reported as:
Count of participants · Participants
Number and Percentage of All SAEs by Severity and Relatedness
ParticipantsPneumosilSynflorix
Bronchiolitis — Moderate-Not Related00
Bronchiolitis — Severe-Not Related134
Bronchiolitis — None1490743
Gastroenteritis — Moderate-Not Related40
Gastroenteritis — Severe-Not Related53
Gastroenteritis — None1494744
Pneumonia — Moderate-Not Related00
Pneumonia — Severe-Not Related46
Pneumonia — None1499741
Dysentery — Moderate-Not Related00
Dysentery — Severe-Not Related01
Dysentery — None1503746
Febrile infection — Moderate-Not Related01
Febrile infection — Severe-Not Related00
Febrile infection — None1503746
HIV infection WHO clinical stage IV — Moderate-Not Related00
HIV infection WHO clinical stage IV — Severe-Not Related01
HIV infection WHO clinical stage IV — None1503746
Meningitis pneumococcal — Moderate-Not Related00
Meningitis pneumococcal — Severe-Not Related10
Meningitis pneumococcal — None1502747
Perinatal HIV infection — Moderate-Not Related00
Perinatal HIV infection — Severe-Not Related01
Perinatal HIV infection — None1503746
Periorbital cellulitis — Moderate-Not Related00
Periorbital cellulitis — Severe-Not Related01
Periorbital cellulitis — None1503746
Upper respiratory tract infection — Moderate-Not Related00
Upper respiratory tract infection — Severe-Not Related10
Upper respiratory tract infection — None1502747
Fallot's tetralogy — Moderate-Not Related00
Fallot's tetralogy — Severe-Not Related11
Fallot's tetralogy — None1502746
Trisomy 21 — Moderate-Not Related00
Trisomy 21 — Severe-Not Related20
Trisomy 21 — None1501747
Atrioventricular septal defect — Moderate-Not Related00
Atrioventricular septal defect — Severe-Not Related10
Atrioventricular septal defect — None1502747
Intussusception — Moderate-Not Related00
Intussusception — Severe-Not Related20
Intussusception — None1501747
Diarrhoea haemorrhagic — Moderate-Not Related00
Diarrhoea haemorrhagic — Severe-Not Related10
Diarrhoea haemorrhagic — None1502747
Vomiting — Moderate-Not Related00
Vomiting — Severe-Not Related10
Vomiting — None1502747
Developmental delay — Moderate-Not Related00
Developmental delay — Severe-Not Related10
Developmental delay — None1502747
Malnutrition — Moderate-Not Related00
Malnutrition — Severe-Not Related01
Malnutrition — None1503746
Seizure — Moderate-Not Related00
Seizure — Severe-Not Related10
Seizure — None1502747
Epistaxis — Moderate-Not Related00
Epistaxis — Severe-Not Related10
Epistaxis — None1502747
Stevens-Johnson syndrome — Moderate-Not Related00
Stevens-Johnson syndrome — Severe-Not Related10
Stevens-Johnson syndrome — None1502747
SecondaryNumber and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody

Subjects with 6A and 19A serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA

Time frame:
4 weeks after the third dose
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody
ParticipantsPneumosilSynflorix
Pn IgG Type 6A119362
Pn IgG Type 19A1386293
Statistical analysis
  • Pneumosil vs Synflorix · Difference for type 6a: 73.3 · 97.5% CI 69.8 to 76.3
  • Pneumosil vs Synflorix · Difference for type 19a: 54.7 · 97.5% CI 50.3 to 58.9
Secondary6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody

6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA

Time frame:
4 weeks after the third dose
Reported as:
Geometric mean · µg/mL
6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody
µg/mLPneumosilSynflorix
Pn IgG Type 6A1.00 (0.95 to 1.06)0.12 (0.11 to 0.12)
Pn IgG Type 19A1.64 (1.57 to 1.72)0.29 (0.27 to 0.31)
Statistical analysis
  • Pneumosil vs Synflorix · Pn igg type 6a gmc ratio: 8.51 · 97.5% CI 7.68 to 9.43
  • Pneumosil vs Synflorix · Pn igg type 19a gmc ratio: 5.64 · 97.5% CI 5.14 to 6.18
SecondaryNumber and Percentage of Subjects With Functional Antibody Responses

Serotype-specific functional antibody titer measured by OPA

Time frame:
4 weeks after the third dose
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With Functional Antibody Responses
ParticipantsPneumosilSynflorix
OPA Type 1229188
OPA Type 5244239
OPA Type 6A24036
OPA Type 6B233212
OPA Type 7F247249
OPA Type 9V242249
OPA Type 14237242
OPA Type 19A22892
OPA Type 19F239246
OPA Type 23F246243
Statistical analysis
  • Pneumosil vs Synflorix · Opa type 1: 17.2 · 95% CI 11.0 to 23.6
  • Pneumosil vs Synflorix · Opa type 5: 2.8 · 95% CI -0.0 to 6.2
  • Pneumosil vs Synflorix · Opa type 6a: 82.2 · 95% CI 76.7 to 86.6
  • Pneumosil vs Synflorix · Opa type 6b: 9.4 · 95% CI 4.5 to 14.6
  • Pneumosil vs Synflorix · Opa type 7f: 0.4 · 95% CI -1.1 to 2.2
  • Pneumosil vs Synflorix · Opa type 9v: 0.0CI could not be computed due to 100% response rate
  • Pneumosil vs Synflorix · Opa type14: -0.8 · 95% CI -4.0 to 2.2
  • Pneumosil vs Synflorix · Opa type 19a: 53.3 · 95% CI 46.0 to 60.1
  • Pneumosil vs Synflorix · Opa type 19f: -1.6 · 95% CI -4.9 to 1.2
  • Pneumosil vs Synflorix · Opa type 23f: 0.0CI could not be computed due to 100% response rate
SecondarySerotype-specific OPA Geometric Mean Titer

Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset

Time frame:
4 weeks after the third dose
Reported as:
Geometric mean · titer
Serotype-specific OPA Geometric Mean Titer
titerPneumosilSynflorix
OPA Type 185.17 (71.34 to 101.69)27.55 (22.96 to 33.06)
OPA Type 5161.34 (139.94 to 186.02)115.93 (98.85 to 135.97)
OPA Type 6A1317.16 (1109.36 to 1563.88)7.06 (5.83 to 8.56)
OPA Type 6B913.52 (745.97 to 1118.70)467.65 (365.27 to 598.73)
OPA Type 7F1833.71 (1612.31 to 2085.51)1586.75 (1392.62 to 1807.94)
OPA Type 9V141.72 (113.36 to 177.16)376.77 (324.01 to 438.13)
OPA Type 141019.34 (816.53 to 1272.52)1102.64 (878.56 to 1383.87)
OPA 19A148.59 (121.35 to 181.95)11.09 (9.19 to 13.39)
OPA 19F594.27 (509.98 to 692.49)895.39 (784.96 to 1021.35)
OPA 23F767.24 (648.95 to 907.10)253.09 (197.10 to 325.00)
Statistical analysis
  • Pneumosil vs Synflorix · Opa gmt ratio-type 1: 3.09 · 95% CI 2.40 to 3.98
  • Pneumosil vs Synflorix · Opa gmt ratio-type 5: 1.39 · 95% CI 1.12 to 1.72
  • Pneumosil vs Synflorix · Opa gmt ratio-type 6a: 186 · 95% CI 144 to 241
  • Pneumosil vs Synflorix · Opa gmt ratio-type 6b: 1.95 · 95% CI 1.42 to 2.69
  • Pneumosil vs Synflorix · Opa gmt ratio-type 7f: 1.16 · 95% CI 0.96 to 1.39
  • Pneumosil vs Synflorix · Opa gmt ratio-type 9v: 0.38 · 95% CI 0.29 to 0.49
  • Pneumosil vs Synflorix · Opa gmt ratio-type 14: 0.92 · 95% CI 0.67 to 1.27
  • Pneumosil vs Synflorix · Opa gmt ratio-type 19a: 13.4 · 95% CI 10.2 to 17.7
  • Pneumosil vs Synflorix · Opa gmt ratio-type 19f: 0.66 · 95% CI 0.54 to 0.81
  • Pneumosil vs Synflorix · Opa gmt ratio-type 23f: 3.03 · 95% CI 2.25 to 4.09
SecondaryComparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose

Comparison of Serotype-specific booster responses (antibody concentrations) measured by ELISA from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose

Time frame:
4 weeks post booster vaccination
Reported as:
Geometric mean · µg/mL
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
µg/mL4 Weeks Post Dose 3-Pneumosil4 Weeks Post Booster-Pneumosil4 Weeks Post Dose 3-Synflorix4 Weeks Post Booster-Synflorix
Pn IgG Type 14.05 (3.76 to 4.36)5.71 (5.25 to 6.21)2.12 (1.88 to 2.38)2.47 (2.19 to 2.80)
Pn IgG Type 51.49 (1.39 to 1.59)1.31 (1.21 to 1.41)1.26 (1.14 to 1.38)0.84 (0.76 to 0.93)
Pn IgG Type 6A1.09 (0.98 to 1.22)4.86 (4.40 to 5.38)0.12 (0.11 to 0.14)0.42 (0.36 to 0.50)
Pn IgG Type 6B1.29 (1.13 to 1.48)8.32 (7.70 to 8.99)1.15 (0.94 to 1.41)4.44 (4.00 to 4.93)
Pn IgG Type 7F3.12 (2.89 to 3.37)6.36 (5.87 to 6.89)2.49 (2.22 to 2.79)4.07 (3.67 to 4.52)
Pn IgG Type 9V1.29 (1.20 to 1.39)1.80 (1.67 to 1.94)1.43 (1.28 to 1.60)2.08 (1.87 to 2.31)
Pn IgG Type 145.06 (4.57 to 5.62)6.84 (6.08 to 7.68)3.86 (3.25 to 4.57)4.67 (2.92 to 5.55)
Pn IgG Type 19A1.50 (1.37 to 1.64)3.97 (3.63 to 4.33)0.26 (0.23 to 0.31)0.95 (0.79 to 1.15)
Pn IgG Type 19F4.16 (3.85 to 4.48)6.18 (5.70 to 6.71)6.31 (5.51 to 7.24)9.79 (8.77 to 10.92)
Pn IgG Type 23F1.65 (1.50 to 1.80)4.11 (3.75 to 4.50)0.94 (0.80 to 1.11)2.15 (1.90 to 2.44)
Statistical analysis
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 1 gmc ratio: 1.41 · 95% CI 1.31 to 1.52
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 5 gmc ratio: 0.88 · 95% CI 0.81 to 0.95
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 6a gmc ratio: 4.46 · 95% CI 4.01 to 4.96
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 6b gmc ratio: 6.43 · 95% CI 5.70 to 7.26
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 7f gmc ratio: 2.04 · 95% CI 1.89 to 2.19
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 9v gmc ratio: 1.39 · 95% CI 1.29 to 1.50
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 14 gmc ratio: 1.35 · 95% CI 1.21 to 1.51
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 19a gmc ratio: 2.64 · 95% CI 2.40 to 2.91
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 19f gmc ratio: 1.49 · 95% CI 1.36 to 1.63
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Pn igg type 23f gmc ratio: 2.50 · 95% CI 2.29 to 2.72
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 1 gmc ratio: 1.17 · 95% CI 1.06 to 1.28
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 5 gmc ratio: 0.67 · 95% CI 0.61 to 0.74
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 6a gmc ratio: 3.49 · 95% CI 2.97 to 4.11
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 6b gmc ratio: 3.85 · 95% CI 3.23 to 4.59
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 7f gmc ratio: 1.63 · 95% CI 1.47 to 1.82
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 9v gmc ratio: 1.46 · 95% CI 1.31 to 1.62
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 14 gmc ratio: 1.21 · 95% CI 1.03 to 1.42
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 19a gmc ratio: 3.60 · 95% CI 2.99 to 4.33
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 19f gmc ratio: 1.55 · 95% CI 1.38 to 1.75
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Pn igg type 23f gmc ratio: 2.29 · 95% CI 1.98 to 2.65
SecondarySerotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose

Comparison of Serotype-specific booster responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose

Time frame:
4 weeks post booster vaccination
Reported as:
Geometric mean · µg/mL
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
µg/mLPneumosilSynflorix
Pn IgG Type 15.73 (5.27 to 6.22)2.45 (2.16 to 2.78)
Pn IgG Type 51.31 (1.21 to 1.41)0.83 (0.75 to 0.92)
Pn IgG Type 6A4.87 (4.41 to 5.39)0.42 (0.35 to 0.49)
Pn IgG Type 6B8.33 (7.71 to 9.00)4.42 (3.98 to 4.90)
Pn IgG Type 7F6.37 (5.88 to 6.90)4.06 (3.65 to 4.50)
Pn IgG Type 9V1.81 (1.67 to 1.95)2.07 (1.87 to 2.30)
Pn IgG Type 146.85 (6.09 to 7.70)4.62 (3.88 to 5.50)
Pn IgG Type 19A3.97 (3.64 to 4.34)0.94 (0.78 to 1.14)
Pn IgG Type 19F6.16 (5.68 to 6.68)9.70 (8.68 to 10.83)
Pn IgG Type 23F4.08 (3.72 to 4.47)2.13 (1.88 to 2.42)
Statistical analysis
  • Pneumosil vs Synflorix · Pn igg type 1 gmc ratio: 2.34 · 95% CI 2.02 to 2.71
  • Pneumosil vs Synflorix · Pn igg type 5 gmc ratio: 1.57 · 95% CI 1.38 to 1.79
  • Pneumosil vs Synflorix · Pn igg type 6a gmc ratio: 11.6 · 95% CI 9.67 to 14.0
  • Pneumosil vs Synflorix · Pn igg type 6b gmc ratio: 1.89 · 95% CI 1.65 to 2.15
  • Pneumosil vs Synflorix · Pn igg type 7f gmc ratio: 1.57 · 95% CI 1.37 to 1.80
  • Pneumosil vs Synflorix · Pn igg type 9v gmc ratio: 0.87 · 95% CI 0.76 to 0.99
  • Pneumosil vs Synflorix · Pn igg type 14 gmc ratio: 1.48 · 95% CI 1.21 to 1.82
  • Pneumosil vs Synflorix · Pn igg type 19a gmc ratio: 4.22 · 95% CI 3.52 to 5.06
  • Pneumosil vs Synflorix · Pn igg type 19f gmc ratio: 0.63 · 95% CI 0.55 to 0.73
  • Pneumosil vs Synflorix · Pn igg type 23f gmc ratio: 1.91 · 95% CI 1.63 to 2.24
SecondaryComparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose

Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose

Time frame:
4 weeks post booster vaccination
Reported as:
Geometric mean · titer
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
titer4 Weeks Post Dose 3-Pneumosil4 Weeks Post Booster-Pneumosil4 Weeks Post Dose 3-Synflorix4 Weeks Post Booster-Synflorix
OPA Type 199.21 (75.22 to 130.9)344.5 (261.8 to 453.5)29.76 (21.73 to 40.78)187.2 (141.6 to 247.4)
OPA Type 5161.2 (126.8 to 205.0)409.9 (312.4 to 537.8)112.9 (86.79 to 146.9)360.6 (281.9 to 461.2)
OPA Type 6A1225 (900.0 to 1666)3063 (2329 to 4030)6.44 (4.80 to 8.64)39.96 (22.94 to 69.59)
OPA Type 6B771.4 (527.2 to 1129)2897 (2259 to 3714)495.2 (339.6 to 722.1)1610 (1271 to 2040)
OPA Type 7F1795 (1461 to 2205)6977 (5602 to 8691)1438 (1136 to 1820)4036 (3270 to 4981)
OPA Type 9V168.7 (117.4 to 242.4)1155 (871.4 to 1530)417.0 (323.3 to 537.8)1229 (979.3 to 1542)
OPA Type 141254 (885.8 to 1776)3069 (2287 to 4118)866.8 (579.6 to 1296)1401 (967.4 to 2029)
OPA Type 19A177.5 (131.0 to 240.5)645.6 (489.7 to 851.0)8.89 (6.81 to 11.60)53.15 (33.24 to 84.99)
OPA Type 19F669.9 (533.6 to 841.2)1592 (1256 to 2019)801.0 (624.1 to 1028)1580 (1190 to 2099)
OPA Type 23F774.5 (588.3 to 1020)3847 (2962 to 4996)211.7 (142.0 to 315.7)1213 (945.7 to 1557)
Statistical analysis
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 1: 3.47 · 95% CI 2.72 to 4.44
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 5: 2.54 · 95% CI 2.06 to 3.13
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 6a: 2.50 · 95% CI 1.83 to 3.42
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 6b: 3.76 · 95% CI 2.48 to 5.69
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 7f: 3.89 · 95% CI 2.92 to 5.18
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 9v: 6.85 · 95% CI 4.45 to 10.52
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 14: 2.45 · 95% CI 1.64 to 3.65
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 19a: 3.64 · 95% CI 2.47 to 5.36
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 19f: 2.38 · 95% CI 1.80 to 3.14
  • 4 Weeks Post Dose 3-Pneumosil vs 4 Weeks Post Booster-Pneumosil · Opa gmt ratio-type 23f: 4.97 · 95% CI 3.49 to 7.06
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 1: 6.29 · 95% CI 4.97 to 7.96
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 5: 3.19 · 95% CI 2.56 to 3.98
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 6a: 6.21 · 95% CI 3.55 to 10.84
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 6b: 3.25 · 95% CI 2.25 to 4.70
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 7f: 2.81 · 95% CI 2.13 to 3.69
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 9v: 2.95 · 95% CI 2.15 to 4.04
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 14: 1.62 · 95% CI 1.06 to 2.46
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 19a: 5.98 · 95% CI 3.88 to 9.21
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 19f: 1.97 · 95% CI 1.45 to 2.68
  • 4 Weeks Post Dose 3-Synflorix vs 4 Weeks Post Booster-Synflorix · Opa gmt ratio-type 23f: 5.73 · 95% CI 3.80 to 8.63
SecondarySerotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose

Comparison of Serotype-specific booster responses (functional response) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose

Time frame:
4 weeks post booster vaccination
Reported as:
Geometric mean · titer
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
titerPneumosilSynflorix
OPA Type 1344.53 (261.77 to 453.46)187.16 (141.59 to 247.40)
OPA Type 5409.87 (312.35 to 537.84)360.59 (281.89 to 461.25)
OPA Type 6A3063.37 (2328.56 to 4030.06)44.98 (25.86 to 78.25)
OPA Type 6B2824.56 (2207.88 to 3613.50)1610.81 (1276.29 to 2033.01)
OPA Type 7F6977.27 (5601.56 to 8690.85)4036.08 (3270.20 to 4981.32)
OPA Type 9V1137.28 (862.30 to 1499.94)1229.05 (979.30 to 1542.50)
OPA Type 143114.71 (2331.38 to 4161.22)1411.94 (978.24 to 2037.92)
OPA Type 19A645.56 (489.69 to 851.04)51.47 (32.40 to 81.76)
OPA Type 19F1592.40 (1255.72 to 2019.35)1580.46 (1189.81 to 2099.38)
OPA Type 23F3846.82 (2962.23 to 4995.58)1226.89 (967.91 to 1555.18)
Statistical analysis
  • Pneumosil vs Synflorix · Opa gmt ratio-type 1: 1.84 · 95% CI 1.25 to 2.72
  • Pneumosil vs Synflorix · Opa gmt ratio-type 5: 1.14 · 95% CI 0.79 to 1.64
  • Pneumosil vs Synflorix · Opa gmt ratio-type 6a: 68.10 · 95% CI 37.07 to 125.09
  • Pneumosil vs Synflorix · Opa gmt ratio-type 6b: 1.75 · 95% CI 1.25 to 2.46
  • Pneumosil vs Synflorix · Opa gmt ratio-type 7f: 1.73 · 95% CI 1.28 to 2.34
  • Pneumosil vs Synflorix · Opa gmt ratio-type 9v: 0.93 · 95% CI 0.65 to 1.32
  • Pneumosil vs Synflorix · Opa gmt ratio-type 14: 2.21 · 95% CI 1.38 to 3.51
  • Pneumosil vs Synflorix · Opa gmt ratio-type 19a: 12.54 · 95% CI 7.36 to 21.37
  • Pneumosil vs Synflorix · Opa gmt ratio-type 19f: 1.01 · 95% CI 0.70 to 1.46
  • Pneumosil vs Synflorix · Opa gmt ratio-type 23f: 3.14 · 95% CI 2.21 to 4.45
SecondaryNumber and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)

Anti-measles IgG, anti-rubella IgG and anti-yellow fever neutralizing antibody titer

Time frame:
4 weeks post booster vaccination
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)
ParticipantsPneumosilSynflorix
Anti-Measles IgG ≥ 150 mIU/mL381183
Anti- Rubella IgG ≥ 4 IU/mL421204
Anti-Yellow Fever neutralizing Ab titer ≥ 1:8420201
Statistical analysis
  • Pneumosil vs Synflorix · Absolute difference for measles: 1.7 · 95% CI -3.3 to 7.4
  • Pneumosil vs Synflorix · Absolute difference for rubella: 1.0 · 95% CI -0.9 to 4.0
  • Pneumosil vs Synflorix · Absolute difference for yellow fever: 2.4 · 95% CI 0.2 to 5.9
Other pre-specifiedProportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster

Treatment group proportions and treatment-group difference in proportions of IgG responders (IgG concentration ≥ 0.35 μg/mL)

Time frame:
One Year Post Booster Vaccination
Reported as:
Count of participants · Participants
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
ParticipantsPneumosilSynflorix
Pn IgG Type 115044
Pn IgG Type 522399
Pn IgG Type 6A30697
Pn IgG Type 6B344143
Pn IgG Type 7F296117
Pn IgG Type 9V209106
Pn IgG Type 14322134
Pn IgG Type 19A316128
Pn IgG Type 19F301174
Pn IgG Type 23F22479
Statistical analysis
  • Pneumosil vs Synflorix · Absolute difference for type 1: 16.2 · 95% CI 8.0 to 23.7
  • Pneumosil vs Synflorix · Absolute difference for type 5: 7.2 · 95% CI -1.4 to 15.8
  • Pneumosil vs Synflorix · Absolute difference for type 6a: 30.0 · 95% CI 21.8 to 38.1
  • Pneumosil vs Synflorix · Absolute difference for type 6b: 16.5 · 95% CI 10.1 to 23.6
  • Pneumosil vs Synflorix · Absolute difference for type 7f: 16.4 · 95% CI 8.4 to 24.5
  • Pneumosil vs Synflorix · Absolute difference for type 9v: -0.2 · 95% CI -8.8 to 8.5
  • Pneumosil vs Synflorix · Absolute difference for type 14: 14.7 · 95% CI 7.5 to 22.3
  • Pneumosil vs Synflorix · Absolute difference for type 19a: 14.7 · 95% CI 7.3 to 22.5
  • Pneumosil vs Synflorix · Absolute difference for type 19f: -13.7 · 95% CI -19.0 to -8.0
  • Pneumosil vs Synflorix · Absolute difference for type 23f: 16.9 · 95% CI 8.2 to 25.4
Other pre-specifiedSerotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster

Comparison of Serotype-specific immune persistence responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix one year post booster

Time frame:
One year post booster vaccination
Reported as:
Geometric mean · µg/mL
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
µg/mLPneumosilSynflorix
Pn IgG Type 10.30 (0.28 to 0.32)0.18 (0.16 to 0.21)
Pn IgG Type 50.40 (0.37 to 0.44)0.34 (0.29 to 0.39)
Pn IgG Type 6A0.73 (0.67 to 0.80)0.31 (0.26 to 0.36)
Pn IgG Type 6B0.90 (0.84 to 0.97)0.62 (0.55 to 0.71)
Pn IgG Type 7F0.64 (0.59 to 0.69)0.49 (0.44 to 0.55)
Pn IgG Type 9V0.38 (0.35 to 0.42)0.41 (0.36 to 0.46)
Pn IgG Type 140.99 (0.89 to 1.10)0.71 (0.59 to 0.85)
Pn IgG Type 19A0.91 (0.81 to 1.01)0.66 (0.55 to 0.78)
Pn IgG Type 19F0.82 (0.73 to 0.92)1.35 (1.17 to 1.55)
Pn IgG Type 23F0.43 (0.39 to 0.48)0.29 (0.25 to 0.34)
Statistical analysis
  • Pneumosil vs Synflorix · Pn igg type 1 gmc ratio: 1.64 · 95% CI 1.42 to 1.89
  • Pneumosil vs Synflorix · Pn igg type 5 gmc ratio: 1.20 · 95% CI 1.03 to 1.40
  • Pneumosil vs Synflorix · Pn igg type 6a gmc ratio: 2.36 · 95% CI 2.01 to 2.78
  • Pneumosil vs Synflorix · Pn igg type 6b gmc ratio: 1.45 · 95% CI 1.27 to 1.66
  • Pneumosil vs Synflorix · Pn igg type 7f gmc ratio: 1.29 · 95% CI 1.12 to 1.49
  • Pneumosil vs Synflorix · Pn igg type 9v gmc ratio: 0.94 · 95% CI 0.81 to 1.09
  • Pneumosil vs Synflorix · Pn igg type 14 gmc ratio: 1.41 · 95% CI 1.15 to 1.72
  • Pneumosil vs Synflorix · Pn igg type 19a gmc ratio: 1.38 · 95% CI 1.14 to 1.68
  • Pneumosil vs Synflorix · Pn igg type 19f gmc ratio: 0.61 · 95% CI 0.50 to 0.74
  • Pneumosil vs Synflorix · Pn igg type 23f gmc ratio: 1.50 · 95% CI 1.24 to 1.81
Other pre-specifiedComparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose

Comparison of Serotype-specific responses (antibody concentrations) measured by ELISA from 4 weeks after a booster dose to one year after a booster dose

Time frame:
One year post booster vaccination
Reported as:
Geometric mean · µg/mL
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
µg/mL4 Weeks Post Booster Dose-PneumosilOne Year Post Booster-Pneumosil4 Weeks Post Booster Dose-SynflorixOne Year Post Booster-Synflorix
Pn IgG Type 15.87 (5.36 to 6.42)0.30 (0.28 to 0.32)2.52 (2.21 to 2.88)0.18 (0.16 to 0.21)
Pn IgG Type 51.35 (1.24 to 1.46)0.40 (0.37 to 0.44)0.85 (0.77 to 0.95)0.34 (0.29 to 0.39)
Pn IgG Type 6A4.86 (4.37 to 5.41)0.73 (0.67 to 0.80)0.43 (0.36 to 0.51)0.31 (0.26 to 0.36)
Pn IgG Type 6B8.48 (7.84 to 9.18)0.90 (0.84 to 0.97)4.45 (3.99 to 4.97)0.62 (0.55 to 0.71)
Pn IgG Type 7F6.40 (5.87 to 6.97)0.64 (0.59 to 0.69)4.14 (3.72 to 4.60)0.49 (0.44 to 0.55)
Pn IgG Type 9V1.86 (1.72 to 2.01)0.38 (0.35 to 0.42)2.08 (1.87 to 2.32)0.41 (0.36 to 0.46)
Pn IgG Type 146.58 (5.80 to 7.46)0.99 (0.89 to 1.10)4.61 (3.83 to 5.56)0.71 (0.59 to 0.85)
Pn IgG Type 19A4.02 (3.66 to 4.42)0.91 (0.81 to 1.01)1.00 (0.82 to 1.22)0.66 (0.55 to 0.78)
Pn IgG Type 19F6.17 (5.65 to 6.73)0.82 (0.73 to 0.92)9.80 (8.72 to 11.02)1.35 (1.17 to 1.55)
Pn IgG Type 23F4.03 (3.66 to 4.45)0.43 (0.39 to 0.48)2.12 (1.86 to 2.42)0.29 (0.25 to 0.34)
Statistical analysis
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 1 gmc ratio: 0.05 · 95% CI 0.05 to 0.06
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 5 gmc ratio: 0.30 · 95% CI 0.27 to 0.33
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 6a gmc ratio: 0.15 · 95% CI 0.13 to 0.16
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 6b gmc ratio: 0.11 · 95% CI 0.10 to 0.11
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 7f gmc ratio: 0.10 · 95% CI 0.09 to 0.11
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 9v gmc ratio: 0.21 · 95% CI 0.19 to 0.23
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 14 gmc ratio: 0.15 · 95% CI 0.13 to 0.17
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 19a gmc ratio: 0.23 · 95% CI 0.20 to 0.26
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 19f gmc ratio: 0.14 · 95% CI 0.12 to 0.15
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Pn igg type 23f gmc ratio: 0.11 · 95% CI 0.10 to 0.12
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 1 gmc ratio: 0.07 · 95% CI 0.06 to 0.08
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 5 gmc ratio: 0.40 · 95% CI 0.35 to 0.45
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 6a gmc ratio: 0.73 · 95% CI 0.62 to 0.86
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 6b gmc ratio: 0.14 · 95% CI 0.12 to 0.16
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 7f gmc ratio: 0.12 · 95% CI 0.11 to 0.13
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 9v gmc ratio: 0.20 · 95% CI 0.18 to 0.22
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 14 gmc ratio: 0.15 · 95% CI 0.13 to 0.19
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 19a gmc ratio: 0.64 · 95% CI 0.52 to 0.78
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 19f gmc ratio: 0.14 · 95% CI 0.12 to 0.16
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Pn igg type 23f gmc ratio: 0.14 · 95% CI 0.12 to 0.16
Other pre-specifiedTreatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster

Serotype-specific functional antibody titer measured by OPA

Time frame:
One year post booster vaccination
Reported as:
Count of participants · Participants
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
ParticipantsPneumosilSynflorix
OPA Type 12714
OPA Type 53937
OPA Type 6A429
OPA Type 6B4331
OPA Type 7F5048
OPA Type 9V4340
OPA Type 144541
OPA Type 19A4324
OPA Type 19F4439
OPA Type 23F4943
Statistical analysis
  • Pneumosil vs Synflorix · Opa type 1: 24.2 · 95% CI 4.5 to 42.1
  • Pneumosil vs Synflorix · Opa type 5: 9.9 · 95% CI -5.8 to 25.5
  • Pneumosil vs Synflorix · Opa type 6a: 65.6 · 95% CI 48.3 to 78.0
  • Pneumosil vs Synflorix · Opa type 6b: 23.2 · 95% CI 6.4 to 39.4
  • Pneumosil vs Synflorix · Opa type 7f: 2.0 · 95% CI -5.2 to 10.8
  • Pneumosil vs Synflorix · Opa type 9v: 0.0CI could not be computed due to 100% response rate
  • Pneumosil vs Synflorix · Opa type14: 4.6 · 95% CI -8.5 to 18.3
  • Pneumosil vs Synflorix · Opa type 19a: 34.4 · 95% CI 16.5 to 50.8
  • Pneumosil vs Synflorix · Opa type 19f: 5.0 · 95% CI -8.4 to 19.2
  • Pneumosil vs Synflorix · Opa type 23f: 0.0CI could not be computed due to 100% response rate
Other pre-specifiedSerotype-specific OPA Geometric Mean Titer One Year Post Booster

Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset one year post booster

Time frame:
One year post booster vaccination
Reported as:
Geometric mean · Titer
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
TiterPneumosilSynflorix
OPA Type 111.0 (8.0 to 15.1)8.7 (5.9 to 12.9)
OPA Type 541.4 (27.6 to 62.0)31.6 (20.0 to 50.1)
OPA Type 6A118.1 (61.6 to 226.5)8.3 (5.0 to 13.6)
OPA Type 6B116.3 (74.9 to 180.6)31.1 (20.5 to 47.2)
OPA Type 7F1765.9 (1238.1 to 2518.8)1851.8 (1251.3 to 2740.5)
OPA Type 9V114.5 (63.8 to 205.5)158.2 (86.3 to 289.9)
OPA Type 14215.1 (126.2 to 366.6)193.4 (107.9 to 346.6)
OPA Type 19A89.7 (50.2 to 160.3)17.6 (11.0 to 28.3)
OPA Type 19F133.5 (68.2 to 261.1)139.8 (78.3 to 249.8)
OPA Type 23F393.8 (219.3 to 707.4)91.6 (54.0 to 155.3)
Statistical analysis
  • Pneumosil vs Synflorix · Opa gmt ratio-type 1: 1.3 · 95% CI 0.8 to 2.1
  • Pneumosil vs Synflorix · Opa gmt ratio-type 5: 1.3 · 95% CI 0.7 to 2.4
  • Pneumosil vs Synflorix · Opa gmt ratio-type 6a: 14.3 · 95% CI 6.3 to 32.1
  • Pneumosil vs Synflorix · Opa gmt ratio-type 6b: 3.7 · 95% CI 2.1 to 6.8
  • Pneumosil vs Synflorix · Opa gmt ratio-type 7f: 1.0 · 95% CI 0.6 to 1.6
  • Pneumosil vs Synflorix · Opa gmt ratio-type 9v: 0.7 · 95% CI 0.3 to 1.7
  • Pneumosil vs Synflorix · Opa gmt ratio-type 14: 1.1 · 95% CI 0.5 to 2.4
  • Pneumosil vs Synflorix · Opa gmt ratio-type 19a: 5.1 · 95% CI 2.4 to 10.8
  • Pneumosil vs Synflorix · Opa gmt ratio-type 19f: 1.0 · 95% CI 0.4 to 2.3
  • Pneumosil vs Synflorix · Opa gmt ratio-type 23f: 4.3 · 95% CI 2.0 to 9.4
Other pre-specifiedComparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose

Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a booster dose to one year post booster

Time frame:
One year post booster vaccination
Reported as:
Geometric mean · Titer
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
Titer4 Weeks Post Booster Dose-PneumosilOne Year Post Booster-Pneumosil4 Weeks Post Booster Dose-SynflorixOne Year Post Booster-Synflorix
OPA Type 1345.8 (256.7 to 465.9)11.0 (8.0 to 15.1)191.7 (144.8 to 253.7)8.7 (5.9 to 12.9)
OPA Type 5422.9 (315.4 to 567.1)41.4 (27.6 to 62.0)369.6 (289.0 to 472.8)31.6 (20.0 to 50.1)
OPA Type 6A3119.4 (2313.3 to 4206.5)118.1 (61.6 to 226.5)49.9 (27.9 to 89.3)8.3 (5.0 to 13.6)
OPA Type 6B3012.0 (2309.2 to 3928.6)116.3 (74.9 to 180.6)1613.8 (1258.1 to 2070.1)31.1 (20.5 to 47.2)
OPA Type 7F6757.8 (5305.8 to 8607.2)1765.9 (1238.1 to 2518.8)4033.5 (3251.2 to 5004.1)1851.8 (1251.3 to 2740.5)
OPA Type 9V1114.9 (828.6 to 1500.2)114.5 (63.8 to 205.5)1231.4 (966.5 to 1568.9)158.2 (86.3 to 289.9)
OPA Type 143128.9 (2279.9 to 4294.0)215.1 (126.2 to 366.6)1423.1 (962.7 to 2103.8)193.4 (107.9 to 346.6)
OPA Type 19A643.6 (479.0 to 864.9)89.7 (50.2 to 160.3)54.6 (34.1 to 87.4)17.6 (11.0 to 28.3)
OPA Type 19F1651.1 (1282.4 to 2125.8)133.5 (68.2 to 261.1)1611.8 (1227.5 to 2116.4)139.8 (78.3 to 249.8)
OPA Type 23F3933.9 (2961.7 to 5225.1)393.8 (219.3 to 707.4)1219.8 (946.8 to 1571.5)91.6 (54.0 to 155.3)
Statistical analysis
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 1: 0.04 · 95% CI 0.03 to 0.06
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 5: 0.11 · 95% CI 0.09 to 0.14
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 6a: 0.05 · 95% CI 0.03 to 0.08
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 6b: 0.05 · 95% CI 0.03 to 0.07
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 7f: 0.26 · 95% CI 0.18 to 0.38
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 9v: 0.12 · 95% CI 0.06 to 0.23
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 14: 0.07 · 95% CI 0.05 to 0.11
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 19a: 0.16 · 95% CI 0.09 to 0.30
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 19f: 0.09 · 95% CI 0.05 to 0.18
  • 4 Weeks Post Booster Dose-Pneumosil vs One Year Post Booster-Pneumosil · Opa gmt ratio-type 23f: 0.12 · 95% CI 0.08 to 0.18
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 1: 0.04 · 95% CI 0.03 to 0.06
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 5: 0.07 · 95% CI 0.05 to 0.10
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 6a: 0.21 · 95% CI 0.09 to 0.48
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 6b: 0.02 · 95% CI 0.01 to 0.03
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 7f: 0.44 · 95% CI 0.30 to 0.65
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 9v: 0.11 · 95% CI 0.06 to 0.20
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 14: 0.11 · 95% CI 0.06 to 0.22
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 19a: 0.26 · 95% CI 0.14 to 0.49
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 19f: 0.09 · 95% CI 0.06 to 0.14
  • 4 Weeks Post Booster Dose-Synflorix vs One Year Post Booster-Synflorix · Opa gmt ratio-type 23f: 0.07 · 95% CI 0.05 to 0.12

Adverse events

Collected over Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pneumosil1/1,503 (0.1%)51/1,503 (3.4%)1,131/1,503 (75.2%)
Synflorix2/747 (0.3%)26/747 (3.5%)572/747 (76.6%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventPneumosilSynflorix
GastroenteritisInfections and infestations15/15039/747
BronchiolitisInfections and infestations14/15034/747
PneumoniaInfections and infestations4/15036/747
Upper respiratory tract infectionInfections and infestations4/15030/747
Periorbital cellulitisInfections and infestations3/15031/747
VomitingGastrointestinal disorders3/15030/747
DysenteryInfections and infestations0/15031/747
Febrile infectionInfections and infestations0/15031/747
HIV infection WHO clinical stage IVInfections and infestations0/15031/747
Perinatal HIV infectionInfections and infestations0/15031/747
Most frequent other events
Showing 10 of 26
Most frequent other events
EventPneumosilSynflorix
Upper respiratory tract infectionInfections and infestations730/1503379/747
DiarrhoeaGastrointestinal disorders281/1503132/747
GastroenteritisInfections and infestations154/150376/747
FuruncleInfections and infestations150/150365/747
ConjunctivitisInfections and infestations110/150364/747
CoughRespiratory, thoracic and mediastinal disorders95/150339/747
BronchiolitisInfections and infestations59/150342/747
Tinea infectionInfections and infestations62/150322/747
Dermatitis diaperSkin and subcutaneous tissue disorders36/150328/747
Febrile infectionInfections and infestations52/150325/747

Baseline characteristics

Age, Continuous
Age, Continuous(Days)Pneumosil Lot 1Pneumosil Lot 2Pneumosil Lot 3SynflorixTotal
Mean47.0 ± 3.7847.1 ± 4.1047.3 ± 4.0347.1 ± 4.0547.2 ± 4.01
Sex: Female, Male
Sex: Female, Male(Participants)Pneumosil Lot 1Pneumosil Lot 2Pneumosil Lot 3SynflorixTotal
Female2522412453471085
Male2502602554001165
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Pneumosil Lot 1Pneumosil Lot 2Pneumosil Lot 3SynflorixTotal
Race-African5025005007472249
Race-Other01001
Ethnicity-Mandinka2642562573971174
Ethnicity-Wolof47585161217
Ethnicity-Fula61636286272
Ethnicity-Jola635463100280
Ethnicity-Serahule1116202976
Ethnicity-Serere2114132169
Ethnicity-Manjago81151135
Ethnicity-Other26292942126
Region of Enrollment
Region of Enrollment(participants)Pneumosil Lot 1Pneumosil Lot 2Pneumosil Lot 3SynflorixTotal
Gambia5025015007472250
07

Study locations

1 site
  • Medical Research Council (MRC) Unit, The Gambia
    Fajara, Gambia
08

References and documents

Publications

  • Clarke E, Bashorun A, Adigweme I, Badjie Hydara M, Umesi A, Futa A, Ochoge M, Obayemi D, Edem B, Saidy-Jah E, Onwuchekwa C, Dhere R, Sethna V, Kampmann B, Goldblatt D, Taylor D, Andi-Lolo I, Hosken N, Antony K, Innis BL, Alderson MR, Lamola S. Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2021 Jun;21(6):834-846. doi: 10.1016/S1473-3099(20)30735-0. Epub 2021 Jan 28. PubMed 33516293 ↗

Study documents

  • Study protocol · Jun 1, 2018
  • Statistical analysis plan · Jun 28, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03197376
Lead sponsor
PATH
Responsible party
Sponsor
First posted
Jun 23, 2017
Start date
Jun 21, 2017
Primary completion
Jun 6, 2018
Completion
May 9, 2019
Results posted
Sep 11, 2019
Last update
Jul 14, 2020

Study contacts

Ed Clarke
principal investigator · Medical Research Council (MRC) Unit, The Gambia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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