A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan
Summary
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers. This study is enrolling participants who are: * Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study * Have a bodyweight of at least 3 kg Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age. Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.
Timeline
- Start
- 2022-09-16
- Primary completion
- 2025-09-20
- Completion
- 2025-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 20-valent pneumococcal conjugate vaccine | Vaccine | — | Intramuscular |
| Comparator | Prevnar 13 | Vaccine | — | Intramuscular |