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

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).

NCT Number	NCT07591181
Lead Sponsor	Beijing Center for Disease Control and Prevention
Conditions	Pneumococcal Disease Prevention
Enrollment	210 participants
Start Date	2026-05-10
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-15