Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Summary
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
Timeline
- Start
- 2025-02-18
- Primary completion
- 2027-10-22
- Completion
- 2027-10-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PCV21 | Vaccine | — | Intramuscular |
| Comparator | Prevnar 20 | Vaccine | — | Intramuscular |
| Background | Havrix | Vaccine | — | Intramuscular |
| Background | M-M-R II | Vaccine | — | Subcutaneous |
| Background | Priorix | Vaccine | — | Subcutaneous |
| Background | RotaTeq | Vaccine | — | Oral |
| Background | Rotarix | Vaccine | — | Oral |
| Background | Vaqta | Vaccine | — | Intramuscular |
| Background | Varivax | Vaccine | — | Subcutaneous |
| Background | Vaxelis | Vaccine | — | Intramuscular |
Indications
No indication recorded.