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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2025-09-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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20-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine (20vPnC)

Group Type EXPERIMENTAL

20-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine (13vPnC)

Group Type ACTIVE_COMPARATOR

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Interventions

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20-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

42 Days

Maximum Eligible Age

84 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes