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NCT Number: NCT07591181

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).

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Key information

Conditions

Pneumococcal Disease Prevention

Age range

60 day–89 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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

Primary outcomes

  1. Seropositivity rate 30 days after the booster dose

    Time frame: 30 days after the booster dose

Sponsors and collaborators

Lead sponsor

Beijing Center for Disease Control and Prevention

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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