COVID-19Phase 3COVID-19NCT05374954

Study on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above

A Phase 3 study testing Omicron COVID-19 Vaccine (Vero Cell), Inactivated and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by China National Biotec Group Company Limited at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Omicron COVID-19 Vaccine (Vero Cell), Inactivated and COVID-19 Vaccine (Vero Cell), Inactivated
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,200 participants
Where: 10 sitesChina
Study dates: 10 May 2022to 10 Nov 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy subjects aged 18 years old and above.
By asking for medical history and physical examination, the investigator judged that the health condition is well.
Has been vaccinated 2 or 3 doses of inactivated COVID-19 vaccine manufactured by BIBP more than 3 months.
Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrolment. 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 be able to comply with the requirements of the clinical study protocol.

Who cannot join

Confirmed or suspected cases of SARS-CoV-2 Infection.
Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
Received one dose or more than 3 doses of inactivated COVID-19 vaccine manufactured by BIBP
Received COVID-19 vaccine manufactured bu other companies (include mRNA, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.)
Axillary body temperature > 37.3 ℃ before vaccination
Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred (self-report, on-site inquiry).

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History of hospital-diagnosed thrombocytopenia or other coagulation disorder
Known immunological impairment or low level with hospital diagnosis
History of uncontrolled epilepsy, other progressive neurological disorders, or Guillain-Barre syndrome (self-report, on-site inquiry).
Known or suspected concomitant serious diseases include: respiratory disease, acute infection or active chronic disease, liver and kidney disease, severe diabetes, malignant tumor, infection or allergic skin disease, HIV infection.
Severe cardiovascular disease (cardiopulmonary failure, uncontrolled hypertension, etc.) diagnosed by the hospital, active chronic respiratory disease
Received live attenuated vaccine within 1 month before enrollment.
Received other vaccines within 14 days before enrollment.
Be participating in or plan to participate in other vaccine clinical trials during this study.
Contraindications related to vaccination as considered by other investigators.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Linli County Center for Disease Control and Prevention
Changde, Hunan, 415200
Changning Center for Disease Control and Prevention
Changning, Hunan, 421500
Ningxiang Center for Disease Control and Prevention
Changsha, Hunan
Outpatient Department of Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan
Loudi Public Health Hospital
Loudi, Hunan
Xiangtan Center for Disease Control and Prevention
Xiangtan, Hunan
Luxi County Center for Disease Control and Prevention
Xiangxi, Hunan
Xiangxiang Center for Disease Control and Prevention
Xiangxiang, Hunan
Huarong County Center for Disease Control and Prevention
Yueyang, Hunan
You County Center for Disease Control and Prevention
Zhuzhou, Hunan, 412300

Other trials in China

About this study

Official title: Safety and Immunogenicity Study on Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above Vaccinated the Prototype Inactivated COVID-19 Vaccine

Read the detailed description

This is a randomized, double blind, positive controlled study to evaluate the safety and immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above who have been vaccinated with 2 or 3 doses of COVID-19 Vaccine (Vero Cell), Inactivated manufactured by Beijing Institute of Biological Products, Co., Ltd. According to subject's age (18-59 vs 60 and above), doses of vaccination history ( 2 doses vs 3 doses), and vaccination interval, the subjects will be stratified and assigned randomly to the study groups ( Omicron inactivated COVID-19 Vaccine) or the control groups ( Prototype inactivated COVID-19 Vaccine) in a 2:1 ratio. All subjects will receive single dose or two doses of vaccine with a interval of 28 days. The occurrence of adverse events within 28 days and serious adverse events within 12 months after vaccination will be observed. The serum antibody levels, cellular immune responses will be analyzed at different time points.

Conditions: COVID-19
Being tested: Omicron COVID-19 Vaccine (Vero Cell), Inactivated, COVID-19 Vaccine (Vero Cell), Inactivated
Keywords: COVID-19, vaccine, inactivated vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omicron COVID-19 Vaccine (Vero Cell), InactivatedBiological
intramuscular injection in the deltoid muscle
COVID-19 Vaccine (Vero Cell), InactivatedBiological
intramuscular injection in the deltoid muscle

Study groups in NCT05374954
Study group	Role	What they receive
A1：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
A2：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
A3：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
A4：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
B1：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
B2：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
B3：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
B4：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
C1：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
C2：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
C3：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
C4：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
C5：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
C6：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
D1：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination	Experimental	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
D2：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination	Active comparator	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
D3：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination	Experimental	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
D4：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination	Active comparator	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
E1：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
E2：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
E3：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
E4：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
E5：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination	Experimental	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
E6：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination	Active comparator	subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
F1：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination	Experimental	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
F2：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination	Active comparator	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated
F3：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination	Experimental	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
F4：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination	Active comparator	subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated

What is being measured

The primary outcome is the main question the study is designed to answer.

The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 28 after vaccination
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 28 after vaccination
Incidence of adverse reactions
Measured: within 28 days after vaccination

Secondary outcomes (7)

The GMT of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 14 after vaccination
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 14 after vaccination
Specific cellular immune response
Measured: within 28 days after vaccination
The neutralizing antibody GMT
Measured: on 3rd month, 6th month, 9th month, and 12th month after vaccination
The proportion of subjects with neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64
Measured: on 3rd month, 6th month, 9th month, and 12th month after vaccination
The incidence of any adverse reactions/events
Measured: 28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Measured: From the beginning of the first dose to 12 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 202210 Nov 2023

First posted16 May 2022
Study start10 May 2022
Primary completion25 Sep 2022
Study completion10 Nov 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05374954
Sponsor's protocol ID: CNBG-BIBP-O-2022004
Acronym: COVID-19
Status last verified: Jun 2023
First submitted: 13 May 2022
Last updated: 18 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Study on Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above Vaccinated the Prototype Inactivated COVID-19 Vaccine
ClinicalTrials.gov ID: NCT05374954
Acronym / sponsor ID: COVID-19 / CNBG-BIBP-O-2022004
Conditions: COVID-19
Keywords: COVID-19, vaccine, inactivated vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 4,200 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Beijing Institute of Biological Products Co Ltd., Hunan Provincial Center for Disease Control and Prevention
Study start: 10 May 2022 (actual)
Primary completion: 25 Sep 2022 (actual)
Study completion: 10 Nov 2023 (estimated)
First posted: 16 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 28

Arm	Type	Receives
A1：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
A2：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
A3：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
A4：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
B1：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
B2：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
B3：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
B4：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
C1：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
C2：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
C3：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
C4：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
C5：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine
C6：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine
D1：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
D2：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
D3：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
D4：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
E1：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
E2：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
E3：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
E4：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
E5：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine
E6：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine
F1：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
F2：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
F3：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination	Experimental	Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
F4：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination	Active comparator	Biological: COVID-19 Vaccine (Vero Cell), Inactivatedsubjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Healthy subjects aged 18 years old and above.
By asking for medical history and physical examination, the investigator judged that the health condition is well.
Has been vaccinated 2 or 3 doses of inactivated COVID-19 vaccine manufactured by BIBP more than 3 months.
Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrolment. 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.

Key exclusion criteria (15 listed)

Confirmed or suspected cases of SARS-CoV-2 Infection.
Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
Received one dose or more than 3 doses of inactivated COVID-19 vaccine manufactured by BIBP
Received COVID-19 vaccine manufactured bu other companies (include mRNA, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.)
Axillary body temperature > 37.3 ℃ before vaccination

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omicron COVID-19 Vaccine (Vero Cell), Inactivatedintramuscular injection in the deltoid muscle	Biological	A1：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination, A3：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination, B1：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination, B3：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination, C1：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination, C3：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination, C5：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination, D1：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination, D3：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination, E1：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination, E3：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination, E5：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination, F1：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination, F3：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination
COVID-19 Vaccine (Vero Cell), Inactivatedintramuscular injection in the deltoid muscle	Biological	A2：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination, A4：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination, B2：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination, B4：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination, C2：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination, C4：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination, C6：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination, D2：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination, D4：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination, E2：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination, E4：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination, E6：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination, F2：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination, F4：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination

Primary outcome

The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after vaccination
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after vaccination
Incidence of adverse reactions
Time frame: within 28 days after vaccination

7 secondary outcomes

The GMT of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after vaccination
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after vaccination
Specific cellular immune response
Time frame: within 28 days after vaccination
The neutralizing antibody GMT
Time frame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
The proportion of subjects with neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64
Time frame: on 3rd month, 6th month, 9th month, and 12th month after vaccination
The incidence of any adverse reactions/events
Time frame: 28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Time frame: From the beginning of the first dose to 12 months after vaccination

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2 (time frame: On Day 28 after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374954.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.