New pneumococcal vaccine for healthy infants

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 is a Phase 3 interventional trial comparing a new 20-valent pneumococcal vaccine to the currently used Prevnar 20 in healthy infants around 2 months old. Approximately 2,400 participants will be randomized into two groups to receive the vaccines and be followed for safety. The study aims to determine whether the new vaccine has a safety profile similar to Prevnar 20 and whether it may provide additional protection against pneumococcal germs not covered by existing vaccines. Enrollment is limited to healthy infants at participating centers in Florida. No collaborators beyond the sponsor are listed, and the study is led by Pfizer with multiple pediatric sites involved.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Infants who are about 2 months of age
* 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.

Where it's running

• Starz Pediatrics
  Estero, Florida, United States Recruiting
• Innovate Research Centers, LLC
  Fort Lauderdale, Florida, United States Recruiting
• MacKoul Pediatrics Fort Myers
  Fort Myers, Florida, United States Recruiting
• Speranza Research Center
  Hialeah, Florida, United States Recruiting
• Dr. Gala, LLC
  Miami, Florida, United States Recruiting
• Rophe Adult and Pediatric Medicine/SKYCRNG
  Union City, Georgia, United States Recruiting

+41 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.