Safety and immune response of three PG4 vaccine lots vs 20vPnC in adults

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 compares the safety and immunogenicity of three consecutive lots of a multivalent pneumococcal conjugate vaccine (PG4) with the currently used 20vPnC vaccine in adults aged 18–49 who have not received a pneumococcal vaccine for at least five years. Participants are randomized in a 2:2:2:1 ratio to receive one injection from PG4 lots 1–3 or 20vPnC, with blood samples collected to measure immune responses. The study aims to demonstrate lot-to-lot consistency for PG4 and to compare its safety profile with the standard vaccine. It will be conducted at multiple sites in the United States under Pfizer sponsorship.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age.

Exclusion Criteria:

Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.

Where it's running

• Achieve Clinical Research, LLC d/b/a Accel Research Sites - Birmingham Clinical Research Unit
  Birmingham, Alabama, United States Recruiting
• Orange County Research Center
  Lake Forest, California, United States Recruiting
• Diablo Clinical Research, LLC dba Flourish Research
  Walnut Creek, California, United States Recruiting
• Clinical Research Consulting
  Milford, Connecticut, United States Recruiting
• Suncoast Research Associates
  Doral, Florida, United States Recruiting
• Research Centers of America
  Hollywood, Florida, United States Recruiting

Study contacts

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

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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.