NCT05382871

Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above

A Randomized, Double-Blinded, Cohort Clinical Study on Evaluating the Safety and Immunogenicity of Sequential Immunization of Two Doses of BIBP Inactivated COVID-19 Vaccine (Omicron), WIBP Inactivated COVID-19 Vaccine (Omicron) or Inactivated COVID-19 Vaccine (Prototype) in Population Aged 18 Years and Above Who Have Completed Two or Three Doses of Inactivated or mRNA Vaccine

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,804 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)	intramuscular injection in the deltoid muscle
BIOLOGICAL	WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)	intramuscular injection in the deltoid muscle
BIOLOGICAL	COVID-19 Vaccine (Vero Cell), Inactivated	intramuscular injection in the deltoid muscle

Timeline

• Start date: 2022-05-27
• Primary completion: 2023-07-27
• Completion: 2024-03-31
• First posted: 2022-05-19
• Last updated: 2023-06-18

Locations

1 site across 1 country: Hong Kong