NCT05512819

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

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN IN A SERIES OF 3 INFANT DOSES AND 1 TODDLER DOSE IN INFANTS IN INDIA AND TAIWAN

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 42 Days – 84 Days
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	20-valent pneumococcal conjugate vaccine	20-valent pneumococcal conjugate vaccine
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine

Timeline

• Start date: 2022-09-16
• Primary completion: 2025-09-20
• Completion: 2025-09-20
• First posted: 2022-08-23
• Last updated: 2025-12-15

Locations

11 sites across 2 countries: India, Taiwan