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Immunity Persistence of Inlive (EV71 Vaccine) in Children 6-71 Months
NCT05397587Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Jul 2022
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- Sinovac Biotech Ltd.
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- HIV-associated central nervous system involvement (HAND)
01
Overview
Phase 4, open-label trial of enterovirus 71 vaccine (vero cell), inactivated in HIV-associated central nervous system involvement (HAND) (4 arms), sponsored by Sinovac Biotech Ltd. Primary endpoints: Seroconversion rates of EV71 neutralizing antibody and Geometric Mean Titer of EV71 neutralizing antibody. Planned start Jul 2022; status: not yet recruiting.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Experimental 6-23m
Subjects aged 6-23 months who received Sinovac EV71 vaccine
Experimental 24-35m
Subjects aged 24-35 months who received Sinovac EV71 vaccine
Experimental 36-71m
Subjects aged 36-71 months who received Sinovac EV71 vaccine
Control 36-71m
Subjects aged 36-71 months who received CAMS EV71 vaccine
03
Who it enrols
Subjects who completed the EV71 vaccine extended age clinical trial (received two doses) in the PPS set.
04
Endpoints
Primary
Seroconversion rates of EV71 neutralizing antibody
Geometric Mean Titer of EV71 neutralizing antibody
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