Safety Study of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older
NCT02544698 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2016-06-17
Summary
This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and 2-5 years old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will receive 3 doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.
Conditions
- Pneumococcal 13-valent Conjugate Vaccine
Interventions
- BIOLOGICAL
-
One dose of PCV13a vaccine
- BIOLOGICAL
-
One dose of PCV13a vaccine
- BIOLOGICAL
-
three doses of PCV13a vaccine
- BIOLOGICAL
-
three doses of PCV13a vaccine
Sponsors & Collaborators
-
Beijing Chaoyang District Centre for Disease Control and Prevention
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
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