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

NCT05382871 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1804

Last updated 2023-06-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • Wuhan Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • The University of Hong Kong

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Ivan Hung, Clinical Professor · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2023-07-27
Completion
2024-03-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382871 on ClinicalTrials.gov