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

NCT05512819 | Completed Phase 3 DMC

• 2 other identifiers: B7471024NCT05512819
• Study Type: interventional
• Target: 541
• Locations: 2 countries
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country

  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

  1 month after Dose 3

• GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group

  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

  1 month after Dose 4

Study Arms (2)

20-valent pneumococcal conjugate vaccine

EXPERIMENTAL

Pneumococcal conjugate vaccine (20vPnC)

Biological: 20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

ACTIVE COMPARATOR

Pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine

Interventions

20-valent pneumococcal conjugate vaccine BIOLOGICAL

20-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Eligibility Criteria

• Age: 42 Days - 84 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 395002, India

Location

BGS Global Institute of Medical Sciences (BGSGIMS)

Bangalore, Karnataka, 560060, India

Location

Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre

Pune, Maharashtra, 411043, India

Location

Maulana Azad Medical College and Associated with Lok Nayak Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, 305001, India

Location

Institute of Child Health

Kolkata, West Bengal, 700017, India

Location

Hsinchu Mackay Memorial Hospital

Hsinchu, Hsinchu, 30071, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: September 16, 2022
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (6); TW (5)