20vPnC vaccine testing in healthy Chinese 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, randomized, controlled trial comparing the 20vPnC vaccine with the approved 13vPnC vaccine for infants. Healthy infants aged about 2 months will receive four doses over roughly 16 to 19 months, with the first three doses at 2, 4, and 6 months and a booster at 12 to 15 months. Participants will be followed to assess safety and immune response to 20vPnC versus 13vPnC. A subset of participants may stay in the study longer for extended observation.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

\- Healthy male or female infants born at ≥37 weeks of gestation and who are approximately 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered Day 1 of life) will be enrolled.

Key Exclusion Criteria:

* history of a severe adverse reaction associated with a vaccine and/or severe allergic reactions to any component of the study intervention.
* significant neurological disorder or history of seizure or significant stable or evolving disorders.
* major known congenital malformation or serious chronic disorder.
* history of microbiologically proven invasive disease caused by S. pneumoniae.
* known or suspected immunodeficiency or other conditions associated with immunosuppression.
* previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.

Where it's running

• Hezhou Center for Disease Control and Prevention
  Hezhou, Guangxi, China Recruiting
• Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
  Nanning, Guangxi, China Recruiting
• Wuming District Center for Disease Control and Prevention
  Nanning, Guangxi, China Recruiting
• Zhongshan County Center for Disease Control and Prevention
  Zhongshan Town, Guangxi, China 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.