NCT07754539 A Study to Evaluate 20vPnC in Healthy Chinese Infants
| NCT ID | NCT07754539 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Pneumococcal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2026-07-25 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,250 participants in total. It began in 2026-07-25 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 19 months. A subset of infants will be asked to stay in the study for longer.
Eligibility Criteria
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07754539 clinical trial?
This trial is open to participants of all sexes, aged 42 Days or older, up to 98 Days, studying Pneumococcal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07754539 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,250 participants.
Is NCT07754539 currently recruiting?
Yes, NCT07754539 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07754539 trial being conducted?
This trial is being conducted at Hezhou, China, Nanning, China, Nanning, China, Zhongshan Town, China.
Who is sponsoring the NCT07754539 clinical trial?
NCT07754539 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 1,250 participants.