New pneumococcal vaccine safety and immune response in children and teens

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, Phase 3 trial evaluates a catch-up pneumococcal conjugate vaccine in participants aged 15 months to under 18 years who have prior PCV exposure. Safety and tolerability are primary considerations, with immune response measured by blood tests to see how well the vaccine prompts antibodies against pneumococcal germs. The trial compares the new vaccine to Prevnar 20 and looks for potentially broader protection against strains not covered by current vaccines. Cohorts are organized by age, and exclusions include significant medical conditions and pregnancy in those eligible to become pregnant. Lead sponsor is Pfizer, with multiple sites in Alabama participating in the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Cohort 1 (Participants ≥15 Months to \<2 Years of Age) Healthy toddlers and children ≥15 months to \<2 years of age with documentation of prior receipt of PCV.

Cohort 2 (Participants ≥2 Years to \<5 Years of Age) Healthy toddlers and children ≥2 years to \<5 years of age with documentation of prior receipt of PCV if applicable.

Cohort 3 (Participants ≥5 Years to \<18 Years of Age) Healthy children ≥5 years to \<18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.

Exclusion Criteria:

All Cohorts (Participants ≥15 Months to \<18 Years of Age)

Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial

Where it's running

• Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
  Birmingham, Alabama, United States Recruiting
• UAB Child Health Research Unit (CHRU)
  Birmingham, Alabama, United States Recruiting
• Lakeview Clinical Research, LLC
  Guntersville, Alabama, United States Recruiting
• Apex Research Group
  Fair Oaks, California, United States Recruiting
• Orange County Research Institute
  Ontario, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

+27 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.