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Safety and Immunogenicity of Inactivated EV71 Vaccine in Healthy Adults and Children
NCT04467541Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2019
- Primary completion
- Jan 2020
- Countries
- 1
- Sponsor
- icddr,b
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- HIV-associated central nervous system involvement (HAND)
01
Overview
Phase 2, randomised, open-label trial of enterovirus 71 vaccine (vero cell), inactivated in HIV-associated central nervous system involvement (HAND), sponsored by icddr,b. Primary endpoint: Neutralizing Antibody responses for evaluation of enterovirus 71 (EV71) vaccines at Day 60. Started Dec 2019; status: completed.
02
Design
1 arm- Study design
- RandomizedOpen-label
Inactivated EV71 Vaccine
Participants receive two doses of Inactivated Enterovirus Type 71 Vaccine, one month apart.
03
Who it enrols
Healthy Bangladeshi adults (18-45 years) and children (6-71 months) without history of HFMD, severe allergies, autoimmune diseases, or recent vaccination/immunosuppressive therapy.
04
Endpoints
Primary
Neutralizing Antibody responses for evaluation of enterovirus 71 (EV71) vaccines
Secondary
Safety Outcome
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