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

Pfizer541 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

541

Conditions

Pneumococcal Disease

Interventions

Eligibility

Sex: ALLMin age: 42 DaysMax age: 84 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (11)

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, India

BGS Global Institute of Medical Sciences (BGSGIMS)

Bangalore, Karnataka, India

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

Pune, Maharashtra, India

Maulana Azad Medical College and Associated with Lok Nayak Hospital

New Delhi, National Capital Territory of Delhi, India

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, India

Institute of Child Health

Kolkata, West Bengal, India

Hsinchu Mackay Memorial Hospital

Hsinchu, Hsinchu, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

...and 1 more locations

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1 month after Dose 4

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1 month after Dose 4