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

Beijing Center for Disease Prevention and Control

Status: Not yet enrolling

Conditions: Pneumococcal Disease Prevention

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07591181

BJCDCP-13

Details and patient eligibility

About

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).

Enrollment: 210 estimated patients

Sex: All

Ages: 60 to 89 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

2, 4, and 12 months vaccination schedule

Treatment:

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

B

Placebo Comparator group

Description:

2, 4, 6 and 12 months vaccination schedule

Treatment:

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