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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumococcal Disease Prevention
• Intervention / Treatment: Drug: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; 2, 4, and 12 months vaccination schedule	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
Placebo Comparator: B; 2, 4, 6 and 12 months vaccination schedule	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Seropositivity rate 30 days after the booster dose	30 days after the booster dose

Collaborators and Investigators

• Sponsor: Beijing Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 9, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BJCDCP-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No