Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)
Summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries. The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.
Timeline
- Start
- 2019-08-28
- Primary completion
- 2021-10-29
- Completion
- 2021-10-29
Outcome
Met primary endpoint
paper V114 met non-inferiority criteria for 13 shared serotypes, based on difference in proportions with serotype-specific IgG ≥0.35 μg/mL PMID 36841723 ↗
paper V114 met superiority criteria for serotypes 22F and 33F PMID 36841723 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prevenar 13 | Vaccine | 0.5 ml | Intramuscular |
| Subject | V114 | Vaccine | 0.5 ml | Intramuscular |
| Subject | Vaxelis | Vaccine | 0.5 ml | Intramuscular |
| Background | M-M-R II | Vaccine | 0.5 ml | Subcutaneous |
| Background | Varivax | Vaccine | 0.5 ml | Subcutaneous |