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NOT YET RECRUITING
NCT07591181
NA

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

Sponsor: Beijing Center for Disease Control and Prevention

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

60 Days - 89 Days

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-05-10

Completion Date

2027-12-31

Last Updated

2026-05-15

Healthy Volunteers

Yes

Interventions

DRUG

the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine

2, 4, and 12 months vaccination schedule for arm A and 2, 4, 6 and 12 months vaccination schedule for arm B