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Safety and Immunogenicity of Sequential Immunization with BIBP and WIBP Omicron Inactivated COVID-19 Vaccines
NCT05382871Phase 3
Key facts
- Status
- Unknown
- Start
- May 2022
- Primary completion
- Jul 2023
- Countries
- 1
- Sponsor
- China National Biotec Group
- Modality
- Whole Inactivated Vaccines
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial of inactivated COVID-19 vaccine (Omicron variant) and WIBP Omicron Inactivated COVID-19 vaccine in coronavirus disease 2019 (COVID-19) (6 arms), sponsored by China National Biotec Group. Primary endpoints: Geometric Mean Titer (GMT) of anti-omicron neutralizing antibody and 4-fold rise rate of anti-omicron neutralizing antibody. Status: unknown.
02
Design
6 arms- Study design
- RandomizedDouble-blind
BIBP Omicron (Post-Inactivated)
BIBP Omicron vaccine booster for subjects previously vaccinated with inactivated vaccine
WIBP Omicron (Post-Inactivated)
WIBP Omicron vaccine booster for subjects previously vaccinated with inactivated vaccine
BIBP Omicron (Post-mRNA)
BIBP Omicron vaccine booster for subjects previously vaccinated with mRNA vaccine
WIBP Omicron (Post-mRNA)
WIBP Omicron vaccine booster for subjects previously vaccinated with mRNA vaccine
Prototype (Post-Inactivated)
Prototype vaccine booster for subjects previously vaccinated with inactivated vaccine
Prototype (Post-mRNA)
Prototype vaccine booster for subjects previously vaccinated with mRNA vaccine
03
Who it enrols
Adults aged 18 and older who are healthy and have completed 2 or 3 doses of inactivated or mRNA COVID-19 vaccine at least 3 months prior. Excludes those with history of COVID-19, SARS, or MERS, immunocompromised state, or uncontrolled chronic diseases.
04
Endpoints
Primary
Geometric Mean Titer (GMT) of anti-omicron neutralizing antibody
4-fold rise rate of anti-omicron neutralizing antibody
Secondary
Geometric Mean Titer (GMT) of anti-omicron neutralizing antibody
4-fold rise rate of anti-omicron neutralizing antibody
Specific cellular immune response
Geometric Mean Titer (GMT) of anti-omicron Immunoglobulin G (IgG) antibody
Proportions of neutralizing antibody titer >= 1:16, >= 1:32 and >= 1:64
Incidence of any adverse reactions/events
Incidence of serious adverse events (SAE) and adverse events of special interest (AESI)
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