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

Launched by PFIZER · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new pneumococcal vaccine to see how safe it is and how well it works in toddlers aged 12 to 15 months. Pneumococcal disease can lead to serious infections, so understanding this vaccine's effects is important. To participate, children need to be healthy and have already received three doses of a specific pneumococcal vaccine earlier in life.

If your child is eligible and joins the study, they will be involved for about 6 to 8 months, depending on the group they are assigned to. During this time, you will visit the clinic a few times where doctors will check for any side effects and take some blood samples. There will also be a phone call to follow up on your child's health. The goal is to ensure the vaccine is safe and effective for young children, which could help protect them from pneumococcal disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
• • Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
• • Have received 3 infant doses of 20vPnC at 2, 4, and 6 months of age, with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
• 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 (other than 20vPnC) or planned receipt during study participation.