drugset / Trial / NCT07591181
A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants
RandomizedParallel-groupSingle-blindPrevention
Summary
To compare the immunogenicity of the domestically produced PCV13 vaccine in healthy 2-month-old infants following administration via the 2+1 and 3+1 schedules, with the primary endpoint being the seroprevalence of specific IgG antibodies after completion of the vaccination series.To evaluate the safety of the 2+1 schedule in infants and young children (incidence of adverse events and serious adverse events).
Timeline
- Start
- 2026-05-10
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prevnar 13 | Vaccine | — | — |