drugset / Trial / NCT05512819

A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

NCT05512819

Phase 3 Completed 541 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindPrevention

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

EvaluationDrugModalityDoseRoute
Subject 20-valent pneumococcal conjugate vaccine Vaccine Intramuscular
Comparator Prevnar 13 Vaccine Intramuscular