A Study to Learn About How a New Pneumococcal Vaccine Works in Infants

Launched by PFIZER · Jul 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new pneumococcal vaccine called PG4 to see how safe it is and how well it helps infants fight off infections compared to the currently used vaccine, Prevnar 20® (20vPnC). The research focuses on infants who are 2 months old, born healthy after at least 36 weeks of pregnancy. The goal is to understand how the vaccine works in the body by measuring the immune response, which is how the body defends itself against germs.

If you have a healthy infant who meets these criteria, they could participate in the study, which lasts about 16 to 19 months. During this time, your child will receive a series of vaccinations and have a few clinic visits to check for any side effects. The study will involve collecting blood samples to see how well the vaccine is working. It's a great opportunity to contribute to important research that could help protect infants from serious infections in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female infants born at \>36 weeks of gestation and 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.
• Exclusion Criteria:
• • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
• • 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 investigational product 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.