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

Starting soon · Not applicable

Conditions studied: Pneumococcal Disease Prevention

In brief

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 facts

Study ID: NCT07591181
Run by: Beijing Center for Disease Control and Prevention
People needed: 210
Starts: 2026-05-10
Expected to finish: 2027-12-31
Last updated by the study team: 2026-05-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

1: Age at enrollment: 2 months (60-89 days)
2: A healthy male or female infant, born at term (≥37 weeks' gestation), with a birth weight of ≥2500 g
3: Parents/guardians must provide written informed consent, and participants must be capable of using a thermometer and a ruler and of completing the daily log card as instructed
4: Able to adhere to study protocols, including completing all visits and blood collections

You may not qualify if…

received any pneumococcal vaccine before enrollment or schedule to receive a non-study pneumococcal vaccine during the study
A history of culture-confirmed invasive disease caused by Streptococcus pneumoniae
Known allergy to vaccine components, including excipients, diphtheria toxoid, tetanus toxoid, etc.
Acute illness at enrollment or axillary temperature >37°C
Immune deficiency, chronic illness, or use of immunosuppressive therapy
Patients with thrombocytopenia, any coagulation disorder, or those receiving anticoagulant therapy
Participation in another clinical trial within the past 30 days or during this study
Has received another live attenuated vaccine within the past 14 days, or another inactivated vaccine within the past 7 days
Has received immunoglobulin within the past month
Any circumstances that researchers believe may affect the evaluation of the study

Full record on ClinicalTrials.gov

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