New pneumococcal vaccine in infants shows safety and how it stacks up against Prevnar 20

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 Phase 3 interventional trial evaluates a novel pneumococcal conjugate vaccine in infants aged 2 months to 6 months. It compares safety and immune response to the current Prevnar 20 vaccine when given alongside routine childhood vaccines. Blood tests measure how well the vaccine stimulates antibodies against pneumococcal germs. The study also explores whether the new vaccine covers additional pneumococcal strains not included in the existing vaccine. Participants are assigned to groups based on age and receive the study vaccine under standard clinical supervision.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* infants who are 2 months of age in Group 1.
* infants who are 2 to 6 months of age in Groups 2 and 3.
* 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

• Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
  Birmingham, Alabama, United States Recruiting
• University of Alabama at Birmingham - School of Medicine
  Birmingham, Alabama, United States Recruiting
• Northwest Arkansas Pediatric Clinic
  Fayetteville, Arkansas, United States Recruiting
• The Children's Clinic of Jonesboro, P.A.
  Jonesboro, Arkansas, United States Recruiting
• Helios Clinical Research
  Sherwood, Arkansas, United States Recruiting
• Advanced Research Center, Inc.
  Anaheim, California, United States Recruiting

+80 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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• New pneumococcal vaccine safety and immune response in children and teens

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• New pneumococcal vaccine for healthy infants

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  Recruiting at 72 sites Phase 3 Pfizer · Estero, Florida and 90 other locations · NCT07573462

• Serum collection after Gamma-PN vaccination to support assay development

  This project will collect blood samples from people who receive the Gamma-PN vaccine to help develop lab tests for pneumococcal disease.

  Recruiting Phase 1 GPN Vaccines · Adelaide, South Australia · NCT07205289

• How pneumococcal conjugate vaccines may produce antibodies that protect against serogroup 33.

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  Recruiting Phase 4 University of Alabama at Birmingham · Birmingham, Alabama · NCT07135453

• Pneumococcal Vaccine Test for severely malnourished kids in hospital

  This study tests whether giving Pneumosil to children aged 6–59 months with severe acute malnutrition in hospital elicits a better immune response than a Typhoid vaccine, with follow-up visits over six months.

  Recruiting Phase 4 Menzies School of Health Research · Dili · NCT06817421

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.