drugset / Trial / NCT07591181

A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants

NCT07591181

Not yet recruiting 210 enrolled Beijing Center for Disease Control and Prevention
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

EvaluationDrugModalityDoseRoute
Subject Prevnar 13 Vaccine