Phase 3
N=2,250
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
Pneumonia, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT03197376 ↗Enrolled (actual)
2,250
Serious AEs
3.4%
Results posted
Sep 2019
Primary outcome: Primary: Serotype-specific Geometric Mean Concentration of IgG Antibody — 4.08; 4.24; 4.58; 1.34 µg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pneumosil (Biological); Synflorix (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype-specific Geometric Mean Concentration of IgG Antibody |
4.29; 1.99; 1.65; 1.20; 1.00; 1.13 | — |
| PRIMARY Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL |
1454; 717; 1435; 692; 1193; 555 | — |
| PRIMARY Serotype-specific Geometric Mean Concentration of IgG Antibody |
4.29; 1.99; 1.65; 1.20; 1.00; 1.13 | — |
| PRIMARY Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus) |
447; 225; 447; 225; 447; 224 | — |
| PRIMARY Anti-pertussis Toxoid GMCs for the Pertussis Antigen |
50.95; 61.82 | — |
| PRIMARY Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen |
317.97; 324.87 | — |
| PRIMARY Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 |
516; 249; 183; 88; 52; 27 | — |
| PRIMARY Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 |
590; 271; 121; 70; 25; 19 | — |
| PRIMARY Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 |
576; 301; 122; 51; 37; 7 | — |
| PRIMARY Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster |
404; 197; 14; 12; 9; 4 | — |
| PRIMARY Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness |
0; 0; 714; 366; 0; 0 | — |
| PRIMARY Number and Percentage of All SAEs by Severity and Relatedness |
0; 0; 13; 4; 1490; 743 | — |
| SECONDARY Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody |
1193; 62; 1386; 293 | — |
| SECONDARY 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody |
1.00; 0.12; 1.64; 0.29 | — |
| SECONDARY Number and Percentage of Subjects With Functional Antibody Responses |
229; 188; 244; 239; 240; 36 | — |
| SECONDARY Serotype-specific OPA Geometric Mean Titer |
85.17; 27.55; 161.34; 115.93; 1317.16; 7.06 | — |
| SECONDARY 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 |
4.05; 5.71; 2.12; 2.47; 1.49; 1.31 | — |
| SECONDARY Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose |
5.73; 2.45; 1.31; 0.83; 4.87; 0.42 | — |
| SECONDARY Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose |
99.21; 344.5; 29.76; 187.2; 161.2; 409.9 | — |
| SECONDARY Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose |
344.53; 187.16; 409.87; 360.59; 3063.37; 44.98 | — |
| SECONDARY Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) |
381; 183; 421; 204; 420; 201 | — |
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.
Eligibility Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03197376). 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.