MedTrace Logo

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

NCT05512819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2025-12-15

No results posted yet for this study

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

BIOLOGICAL

20-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
84 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2025-09-20
Completion
2025-09-20

Countries

  • India
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512819 on ClinicalTrials.gov