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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Disease

Treatments

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 20-valent pneumococcal conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05512819

NCT05512819 (Registry Identifier)

B7471024

Details and patient eligibility

About

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.

Enrollment

541 patients

Sex

All

Ages

42 to 84 days old

Volunteers

Accepts Healthy Volunteers

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.