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Learning about a new pneumococcal vaccine for infants

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Phase 2 Interventional Pfizer · NCT06524414

This study is testing a new pneumococcal vaccine for infants to see if it is safe and works better than current vaccines in protecting against infections.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment800 (estimated)
Ages42 Days to 98 Days
SexAll
SponsorPfizer Industry-sponsored
Locations57 sites (Fayetteville, Arkansas and 56 other locations)
Trial IDNCT06524414 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and immune response of a new pneumococcal vaccine (PG4) in infants compared to existing vaccines like Prevnar 20® and PCV15. Infants will receive the vaccine in different solutions to determine if the formulation affects safety and immune response. Blood samples will be collected to measure antibody production, which indicates how well the vaccine protects against infections. The study will help understand the effectiveness of the new vaccine in preventing pneumococcal disease in infants.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants over 2 months old who were born at more than 36 weeks of gestation.

Not a fit: Patients with a history of severe allergic reactions to vaccines or significant congenital malformations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more effective pneumococcal vaccine for infants, enhancing their protection against serious infections.

How similar studies have performed: Other studies have shown success with similar pneumococcal vaccines, indicating a promising approach to enhancing infant immunization.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fayetteville, Arkansas and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pneumococcal Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.