Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups
NCT01654809 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2012-10-02
Summary
The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.
Conditions
Interventions
- BIOLOGICAL
-
evaluated vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
- BIOLOGICAL
-
imported compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
- BIOLOGICAL
-
domestic compared vaccine
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
Sponsors & Collaborators
-
Beijing Center for Disease Control and Prevention
lead OTHER_GOV
Principal Investigators
-
Nianmin Shi, Master · Beijing Chaoyang District Center for Disease Control and Prevention
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2011-02-28
- Completion
- 2011-06-30
Countries
- China
Study Locations
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