Official Title
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
Brief Summary

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

Detailed Description

Not Provided

Active, not recruiting
COVID-19

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

Eligibility Criteria

Inclusion Criteria:

- Age range: populations aged 18 years and above.

- Judged by the investigator that the health condition is well after inquiry and
physical examination.

- Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA vaccine for
≥ 3 months.

- Female participants who are not nursing or pregnant at the time of enrolment
(negative urine pregnancy test) and have no family planning within the first 7
months after enrollment. Effective contraceptive measures have been taken within 2
weeks before inclusion.

- During the whole follow-up period of the study, be able and willing to complete the
whole prescribed study plan.

- With self ability to understand the study procedures, the informed consent &
voluntarily sign an informed consent form and is able to comply with the
requirements of the clinical study protocol.

Exclusion Criteria:

- Confirmed cases, suspected cases or asymptomatic cases of COVID-19;

- With a history of Severe Acute Respiratory Syndrome (SARS) and Middle East
Respiratory Syndrome (MERS) (self-report, on-site inquiry);

- Has vaccinated with one or four doses and above COVID-19 vaccine;

- Axillary temperature ≥37.3℃ (Tympanic temperature ≥ 37.6 ℃);

- Previous allergic reactions to drug or vaccination (such as acute allergic
reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or
allergy to known components of COVID-19 vaccine (self-report, onsite enquiry);

- Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders
(self-report, onsite enquiry);

- With known immunological impairment or immunocompromised diagnosed by the hospital
(self-report, onsite enquiry);

- Have an uncontrolled epilepsy and other progressive neurological diseases or a
history of Guillain-Barre syndrome (self-report, onsite enquiry);

- Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report,
onsite enquiry);

- Known or suspected severe illness includes: respiratory illness, acute infection or
active attacks of chronic illness, liver and kidney disease, severe diabetes
mellitus, malignant tumor, infectious or allergic skin disease, Human
Immunodeficiency Virus (HIV) infection (self-report, onsite enquiry, provide test
report if available);

- With hospital-diagnosed serious cardiovascular diseases (cardiopulmonary failure,
drug-uncontrolled hypertension (physical examination of systolic blood pressure ≥
140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), acute attacks of chronic
respiratory illness (self-report, onsite enquiry);

- Received live attenuated vaccines within 1 month before vaccination (self-report,
onsite enquiry);

- Received inactivated vaccines within 14 days before vaccination (self-report, onsite
enquiry);

- Participating or planning to participate in other interventional vaccine clinical
trials during this study

- Other vaccination-related contraindications considered by investigators.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Hong Kong
Locations

Queen Mary Hospital
Hong Kong, Hong Kong

Ivan Hung, Clinical Professor, Principal Investigator
The University of Hong Kong

China National Biotec Group Company Limited
NCT Number
MeSH Terms
COVID-19
Vaccines