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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 2, 4, and 12 months vaccination schedule |
|
| B | Placebo Comparator | 2, 4, 6 and 12 months vaccination schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rate 30 days after the booster dose | 30 days after the booster dose |
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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:
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