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

NCT07591181 | Not Yet Recruiting DMC

• 1 other identifier: BJCDCP-13
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Pneumococcal Disease Prevention

Outcome Measures

Primary Outcomes (1)

• Seropositivity rate 30 days after the booster dose

  30 days after the booster dose

Study Arms (2)

A

EXPERIMENTAL

2, 4, and 12 months vaccination schedule

Drug: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine

B

PLACEBO COMPARATOR

2, 4, 6 and 12 months vaccination schedule

Drug: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine

Interventions

the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine DRUG

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

A; B

Eligibility Criteria

• Age: 60 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• : Age at enrollment: 2 months (60-89 days)
• : A healthy male or female infant, born at term (≥37 weeks' gestation), with a birth weight of ≥2500 g
• : 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
• : 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

Sponsors & Collaborators

• Beijing Center for Disease Control and Prevention: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05