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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: 20-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Pvt Ltd.
  • Karnataka
    • Bangalore, Karnataka, India, 560060
      • BGS Global Institute of Medical Sciences (BGSGIMS)
  • Maharashtra
    • Pune, Maharashtra, India, 411043
      • Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110002
      • Maulana Azad Medical College and Associated with Lok Nayak Hospital
  • Rajasthan
    • Ajmer, Rajasthan, India, 305001
      • Jawahar Lal Nehru Medical College
  • West Bengal
    • Kolkata, West Bengal, India, 700017
      • Institute of Child Health
• Taiwan
  • Taichung, Taiwan, 407219
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
  • Hsinchu
    • Hsinchu, Hsinchu, Taiwan, 30071
      • HsinChu MacKay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent
• Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
• Weight of 3.0 kg or greater at the time of randomization

Exclusion Criteria:

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine.
• Major known congenital malformation or serious chronic disorder
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20-valent pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine (20vPnC)	Biological: 20-valent pneumococcal conjugate vaccine; 20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine (13vPnC)	Biological: 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country	Prompted local reactions after each dose	Day 7
Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country	Prompted systemic reactions after each dose	Day 7
Percentage of participants in India and Taiwan with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group, separately by country	Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group	Dose 1 to 1 month after Dose 3
Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country	Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group	Dose 4 to 1 month after Dose 4
Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country	SAEs occurring up to 1 month after Dose 4 in each group	Dose 1 to 1 month after Dose 4
GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group	IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only	1 month after Dose 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country	IgG GMCs for the 20vPnC serotypes 1 month after Dose 3	1 month after Dose 3
Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group, separately by country	IgG concentrations for 20vPnC serotypes 1 month after Dose 3	1 month after Dose 3
GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group	IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Taiwanese participants only	1 month after Dose 4
Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group, separately by country	IgG concentrations for 20vPnC serotypes 1 month after Dose 4	1 month after Dose 4

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Actual): September 20, 2025
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; Heptavalent Pneumococcal Conjugate Vaccine; Vaccines
• Other Study ID Numbers: B7471024; NCT05512819 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No