The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
NCT02231632 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2023-10-10
Summary
The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)
Conditions
- Poliomyelitis
Interventions
- BIOLOGICAL
-
Live attenuated Poliomyelitis vaccine (Human Diploid Cell)
6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
- BIOLOGICAL
-
Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)
6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
Sponsors & Collaborators
-
Guangxi Center for Disease Control and Prevention
collaborator OTHER_GOV -
Institute of Medical Biology, Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Qihan Li, Ph.D · Institude of Medical Biology, Chinese Academy of Medical Sciences
-
Jingsi Yang · Institude of Medical Biology, Chinese Academy of Medical Sciences
-
Rongcheng Li · Guangxi Provincial Center for Disease Control and Prevention
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Months
- Max Age
- 4 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-03-31
- Completion
- 2012-08-31
Countries
- China
Study Locations
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