Phase 3
Completed N=660
Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants
Pneumonia, Pneumococcal
Source: ClinicalTrials.gov NCT03896477 ↗
Enrolled (actual)
660
Serious AEs
4.4%
Results posted
Apr 2022
Primary outcomePrimary: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster — 8.45; 2.90; 5.87; 1.54 μg/mL
◆ Published Evidence
Emerging
13citations · ~4 / year
Immunogenicity and safety of a 10-valent pneumococcal conjugate vaccine administered as a 2 + 1 schedule to healthy infants in The Gambia: a single-centre, double-blind, active-controlled, randomised, phase 3 trial.
Summary
The primary objectives of this study are to evaluate the immunogenicity (antibody response) and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.
Linked Publications
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Immunogenicity and safety of a 10-valent pneumococcal conjugate vaccine administered as a 2 + 1 schedule to healthy infants in The Gambia: a single-centre, double-blind, active-controlled, randomised, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster |
8.45; 2.90; 5.87; 1.54; 0.80; 2.04 | — |
| PRIMARY Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination |
72; 84; 63; 0; 0; 0 | — |
| PRIMARY Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) |
198; 197; 189; 1; 2; 0 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
12; 10; 7; 0; 0; 0 | — |
| SECONDARY Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster |
631.29; 282.35; 429.13; 885.98; 484.66; 703.15 | — |
| SECONDARY Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster |
100; 100; 99.5; 97.5; 89.9; 99.0 | — |
| SECONDARY Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster |
98.5; 88.3; 97.5; 68.6; 37.7; 87.5 | — |
| SECONDARY Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster |
100; 96.0; 98.0; 100; 100; 100 | — |
| SECONDARY Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations |
99.5; 96.2; 100; 96.8; 92.0; 96.2 | — |
| SECONDARY Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations |
3.63; 1.36; 3.40; 1.19; 0.87; 1.81 | — |
| SECONDARY Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations |
98.0; 73.5; 96.0; 98.0; 96.0; 100 | — |
| SECONDARY Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations |
99.67; 26.70; 98.63; 182.18; 85.09; 291.98 | — |
| SECONDARY Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster |
50.2; 17.2; 53.4; 13.7; 16.4; 33.8 | — |
| SECONDARY Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster |
0.36; 0.16; 0.37; 0.17; 0.16; 0.24 | — |
| SECONDARY Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster |
22.4; 16.0; 25.5; 58.3; 49.0; 63.3 | — |
| SECONDARY Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster |
5.57; 5.19; 5.45; 12.53; 12.01; 16.03 | — |
| SECONDARY Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations |
2.31; 2.09; 1.74; 1.29; 0.90; 1.15 | — |
| SECONDARY Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations |
6.70; 9.35; 4.45; 4.91; 5.36; 2.46 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infants based on medical history and clinical assessment.
- 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.
- Subjects must have been born full-term, have a weight-to-height Z score of ≥ -2 at the time of enrollment (WHO child growth standard), and be ≥ 3.5 kg at randomization.
- Subject's parents must be available for the duration of trial participation
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 study 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 suddenly without apparent cause.
- History of meningitis, seizures or any neurological disorder.
- Exposure to human immunodeficiency virus (HIV) by history.
Data sourced from ClinicalTrials.gov (NCT03896477) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.