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A Study to Evaluate 20vPnC in Healthy Chinese Infants

RecruitingPhase 3Ages 42 Days - 98 DaysAllPfizer
NCT07754539 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). These antibodies help protect against 20 types of pneumococcal bacteria. The study will compare 20vPnC with 13vPnC (control vaccine), which is approved for use in infants. The study is seeking participants who: * Are healthy infants * Aged 42 to 98 days of age at the time of consent. Infants will receive either 20vPnC or 13vPnC. Doses will be given at approximately 2, 4, and 6 months of age (Doses 1 through 3). A fourth dose will be given at 12 to 15 months of age. Infants will receive the same vaccine (20vPnC or 13vPnC) for all 4 doses. The total time of the study will be about 16 to 1

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📋 Eligibility rules (as published)
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.
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What it tests

  • 20vPnC
  • 13vPnC
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Where

4 sites
Hezhou Center for Disease Control and Prevention
Hezhou, China
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, China
Wuming District Center for Disease Control and Prevention
Nanning, China
Zhongshan County Center for Disease Control and Prevention
Zhongshan Town, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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