A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine.
- Who it may be relevant to
- Registry conditions: Pneumococcal Disease Prevention. Basic parameters: 60 Days — 89 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- 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
Primary outcome measures
- Seropositivity rate 30 days after the booster dose [Time frame: 30 days after the booster dose]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07591181 · BJCDCP-13