Duration of IPV Priming and Antibody Decay
NCT03202719 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1645
Last updated 2020-11-25
Summary
This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms.
Conditions
- Poliomyelitis
Interventions
- BIOLOGICAL
-
Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age
bOPV at 6, 10 and 14 weeks of age
- BIOLOGICAL
-
Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age
IPV at 14 weeks and 18 months of age
- BIOLOGICAL
-
Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age
IPV at 14 weeks, 18 weeks and 18 months of age
- BIOLOGICAL
-
Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age
IPV at 14 weeks and 9 months of age
- BIOLOGICAL
-
Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age
IPV at 6 weeks and 9 months of age
- BIOLOGICAL
-
Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age
IPV at 6 and 14 weeks of age
Sponsors & Collaborators
-
International Centre for Diarrhoeal Disease Research, Bangladesh
collaborator OTHER -
Centers for Disease Control and Prevention
lead FED
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Weeks
- Max Age
- 7 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-11-05
- Primary Completion
- 2019-10-01
- Completion
- 2019-10-01
Countries
- Bangladesh
Study Locations
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