COVID-19Phase 3NCT05381350

Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above

A Phase 3 study testing COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant) and COVID-19 Vaccine (Vero cell), Inactivated (CZ strain) in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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?: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant) and COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,750 participants
Where: 1 siteChina
Study dates: 1 Jun 2022to 9 Mar 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 adults aged 18 years and above;
Subjects completed two doses of the prototype COVID-19 vaccine (CZ strain)(the interval between the first dose and the second dose was 1-2 months)or completed 3 doses of prototype COVID-19 vaccine (CZ strain)over 6 months (the interval between the first dose and the second dose was 1-2 months, and the interval between the second dose and the third dose was 6 months or more);
The subjects can understand and voluntarily sign the informed consent form;
Provide legal identification and vaccination certificate of prototype COVID-19 vaccine (CZ strain).

Who cannot join

History of SARS-CoV-2 infection(laboratory confirmed);
Close contact with a confirmed COVID-19 (nucleic acid test or antigen test positive patients)within 14 days prior to randomization;
Received other COVID-19 vaccine in the past except for two or three doses of prototype vaccine;
Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
Autoimmune disease and/or blood disease history (including but not limited to systemic lupus erythematosus, thyroidectomy, autoimmune thyroid disease, any form of malignancy, absence of spleen, functional absence of spleen, or splenectomy for any condition),patients with well-controlled type 1 diabetes can be enrolled;
Serious chronic diseases, such as serious cardiovascular diseases, hypertension, diabetes, liver and kidney diseases, malignant tumors, etc;

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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
Long-term history of alcohol or drug abuse;
Received blood products within 3 months prior to receiving the investigational vaccine, or planning to receive the above treatments during the study period;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Onset of various acute or chronic diseases within 7 days prior to the study;
In case of fever on the day of planned trial vaccine inoculation,axillary temperature >37.0°C;
Women who are breastfeeding, pregnant, or planning to become pregnant during the study period (based on subjects' self-reported and urine pregnancy test results);
Participating in or planning to participate in clinical trials of other vaccines or drugs;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Huaiyin Center for Disease Control and Prevention
Huai'an, Jiangsu, 223300

Other trials in China

About this study

Official title: A Randomized, Double-blind, Active-controlled Clinical Trial, as Well as an Immuno-bridging Clinical Trial by Parallel Testing Previous Serum After Primary Immunization, to Evaluate the Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above

This is a randomized, double-blind, active-controlled Phase Ⅲ clinical trial, as well as an immuno-bridging clinical trial by parallel testing previous serum after primary immunization of COVID-19 vaccine (Vero cell), inactivated (Omicron variant). The main purpose of this study is to evaluate the superiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant), developed by Sinovac Research and Development Co., Ltd.in subjects who have received two- or three-dose Prototype COVID-19 vaccine （CZ strain）, compared with one-dose booster of Prototype COVID-19 vaccine （CZ strain） in subjects who have received three-dose Prototype COVID-19 vaccine （CZ strain）, and to evaluate the non-inferiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant), developed by Sinovac Research and Development Co., Ltd., in subjects who have received two- or three-dose Prototype COVID-19 vaccine, compared with the immunogenicity against SARS-CoV-2 Prototype strain induced by two-dose Prototype COVID-19 vaccine（CZ strain）after primary immunization.

Read the detailed description

This study is a single-center, randomized, double-blind, active-controlled Phase Ⅲ clinical trial, as well as an immuno-bridging clinical trial by parallel testing previous serum after primary immunization of COVID-19 vaccine (Vero cell), inactivated (Omicron variant). The main purpose of this study is to evaluate the superiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant)developed by Sinovac Life Sciences Co., Ltd.in subjects who have received two- or three-dose COVID-19 vaccine（CZ strain）, compared with one-dose booster of COVID-19 vaccine（CZ strain）in subjects who have received three-dose COVID-19 vaccine（CZ strain）and to evaluate the non-inferiority of immunogenicity against SARS-CoV-2 Omicron strain induced by one-dose booster immunization of inactivated COVID-19 vaccine (Omicron variant), developed by Sinovac Life Sciences Co., Ltd, in subjects who have received two- or three-dose COVID-19 vaccine（CZ strain）,compared with the immunogenicity against SARS-CoV-2（CZ strain）induced by two-dose COVID-19 vaccine（CZ strain）primary immunization. This clinical trial consists of two stages. A total of 1750 healthy subjects will be enrolled including 1500 healthy subjects aged 18 years and older who have received 2 or 3 doses of the COVID-19 vaccine（CZ strain）（750 population were vaccinated with 2 doses and 3 doses of COVID-19 vaccine（CZ strain）respectively）in stage I of the clinical trial,250 subjects in stage Ⅱ of the clinical trial.

Stage I of the clinical trial:1500 healthy subjects （750 population were vaccinated with 2 doses or 3 doses of COVID-19 vaccine（CZ strain）respectively）who have received two or three doses of the prototype (CZ strain) COVID-19 vaccine, including 1200 subjects aged 18~59 years old and 300 subjects aged 60 years and above. Subjects in each age group will be randomly divided into experimental group and control group in a ratio of 2:1. Subjects in the experimental group will receive one dose of inactivated COVID-19 vaccine (Omicron variant), and subjects in the control group will receive one dose of COVID-19 vaccine（CZ strain）.

Stage Ⅱ of the clinical trial:Backup serum samples will be selected from 250 healthy adult subjects aged 26-45 years who received two doses of inactivated COVID-19 vaccine(CZ strain)from clinical trial of lot-to-lot consistency of an inactivated SARS-CoV-2 Vaccine(Pro-NCOV-4001).

Conditions: COVID-19
Being tested: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant), COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)
Medical subject headings: COVID-19

What participants receive

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

COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)Biological
The COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)was manufactured by Sinovac Research\& Development Co., Ltd.1200SOU inactivated SARS-CoV-2 Omicron strain in 0.5ml of aluminium hydroxide solution per injection.
COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)Biological
Also called CoronaVac
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.

Study groups in NCT05381350
Study group	Role	What they receive
Experimental group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）	Experimental	400 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)
Control Group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）	Active comparator	200 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)
Experimental group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）	Experimental	100 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)
Control Group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）	Active comparator	50 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)
Experimental group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）	Experimental	400 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)
Control Group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）	Active comparator	200 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)
Experimental group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）	Experimental	100 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant). Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)
Control Group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）	Active comparator	50 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）. Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)
Historical control group	Active comparator	Backup serum samples will be selected from 250 healthy adult subjects aged 26-45 years who received two doses of inactivated COVID-19 vaccine(CZ strain)from clinical trial of lot-to-lot consistency of an inactivated SARS-CoV-2 Vaccine(Pro-NCOV-4001) to detect neutralizing antibodies against the CZ, Delta and Omicron strains. Receives: Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)

What is being measured

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

Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1)
Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of COVID-19 vaccine (Omicron variant), 28 days (Day 28) after booster vaccination among subjects with two- or three-dose COVID-19 vaccine（CZ strain） ≥6 months before
Measured: 28 days (Day 28) after booster vaccination
GMTs and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1)
GMTs and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of Prototype COVID-19 vaccine, 28 days (Day 28) after booster vaccination among subjects with three-dose Prototype COVID-19 vaccine≥6 months before
Measured: 28 days (Day 28) after booster vaccination
GMTs of the neutralizing antibody to SARS-CoV-2 Prototype strain(CZ strain)
GMTs of the neutralizing antibody to SARS-CoV-2 Prototype strain induced by two doses of Prototype COVID-19 vaccine, 28 days after vaccination in previous clinical trial serums
Measured: 28 days after vaccination of two doses of Prototype COVID-19 vaccine

Secondary outcomes (9)

Geometric mean increases (GMIs) and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2)
Geometric mean increases (GMIs) and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2), induced by a booster dose of COVID-19 vaccine (Omicron variant), 28 days (Day 28) after booster vaccination among subjects with two-dose Prototype COVID-19 vaccine ≥6 months before
Measured: 28 days (Day 28) after booster vaccination
GMIs,seroconversion rates seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2)
GMIs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2), induced by a booster dose of COVID-19 vaccine (Omicron variant) or prototype COVID-19 vaccine, 28 days (Day 28) after booster vaccination among subjects with three-dose Prototype COVID-19 vaccine ≥6 months before
Measured: 28 days (Day 28) after booster vaccination
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain and Delta strain
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain and Delta strain, induced by a booster dose of COVID-19 vaccine (Omicron variant) or Prototype COVID-19 vaccine, 28 days (Day 28) after booster vaccination among subjects with two-dose Prototype COVID-19 vaccine ≥6 months before
Measured: 28 days (Day 28) after booster vaccination
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain) and Delta strain
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain) and Delta strain, induced by a booster dose of COVID-19 vaccine (Omicron variant) or Prototype COVID-19 vaccine, 28 days (Day 28) after booster vaccination among subjects with three-dose Prototype COVID-19 vaccine ≥6 months before
Measured: 28 days (Day 28) after booster vaccination
GMTs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain), Delta strain and Omicron strain (BA.1, BA.2)
GMTs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain), Delta strain and Omicron strain (BA.1, BA.2), induced by two primary doses of Prototype COVID-19 vaccine in previous clinical trial serums, 28 days after primary vaccination
Measured: 28 days after primary vaccination
GMTs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain (CZ strain) and Delta strain
GMTs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain (CZ strain) and Delta strain, induced by one booster dose of COVID-19 vaccine (Omicron variant) or Prototype COVID-19 vaccine, 3 months (Day 90) and 6 months (Day 180) after booster vaccination among subjects with 2 or 3 doses of Prototype COVID-19 vaccine ≥6 months before
Measured: 3 months (Day 90) and 6 months (Day 180) after booster vaccination
Incidence of local and systemic adverse reactions
Incidence of local and systemic adverse reactions within 0~7 days after booster vaccination among subjects with 2 or 3 doses of Prototype COVID-19 vaccine (CZ strain)
Measured: within 0~7 days after booster vaccination
Incidence of serious adverse events (SAE) and adverse events of special interest (AESI)
Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after booster vaccination among subjects with 2 or 3 doses of Prototype COVID-19 vaccine (CZ strain)
Measured: 12 months after booster vaccination
Incidence of adverse reactions within 0~28 days
Incidence of adverse reactions within 0~28 days after booster vaccination among subjects with 2 or 3 doses of Prototype COVID-19 vaccine (CZ strain)
Measured: Within 0~28 days after booster vaccination

Timeline

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

1 Jun 20229 Mar 2023

First posted19 May 2022
Study start1 Jun 2022
Primary completion26 Sep 2022
Study completion9 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05381350
Sponsor's protocol ID: PRO-onCOV-3001
Status last verified: May 2024
First submitted: 18 May 2022
Last updated: 31 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hu J, Liu Y, Liu S, Shu Q, Yang X, Chu K, Qiao Y, Hu Y, Wang K, Pan H. Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial. Front Immunol. 2023 Sep 18;14:1241153. doi: 10.3389/fimmu.2023.1241153. eCollection 2023.
PubMed 37799724

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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Active-controlled Clinical Trial, as Well as an Immuno-bridging Clinical Trial by Parallel Testing Previous Serum After Primary Immunization, to Evaluate the Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above
ClinicalTrials.gov ID: NCT05381350
Acronym / sponsor ID: PRO-onCOV-3001
Conditions: COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,750 participants (actual)
Lead sponsor: Sinovac Research and Development Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Jun 2022 (actual)
Primary completion: 26 Sep 2022 (actual)
Study completion: 9 Mar 2023 (actual)
First posted: 19 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: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Experimental group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）	Experimental	Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)400 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）	Active comparator	Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)200 participants aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Experimental group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）	Experimental	Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)100 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）	Active comparator	Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)50 participants aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Experimental group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）	Experimental	Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)400 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）	Active comparator	Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)200 participants aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Experimental group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）	Experimental	Biological: COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)100 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine (Omicron variant).
Control Group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）	Active comparator	Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)50 participants aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain） will receive one dose of inactivated COVID-19 vaccine（CZ strain）.
Historical control group	Active comparator	Biological: COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)Backup serum samples will be selected from 250 healthy adult subjects aged 26-45 years who received two doses of inactivated COVID-19 vaccine(CZ strain)from clinical trial of lot-to-lot consistency of an inactivated SARS-CoV-2 Vaccine(Pro-NCOV-4001) to detect neutralizing antibodies against the CZ, Delta and Omicron strains.

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy adults aged 18 years and above;
Subjects completed two doses of the prototype COVID-19 vaccine (CZ strain)(the interval between the first dose and the second dose was 1-2 months)or completed 3 doses of prototype COVID-19 vaccine (CZ strain)over 6 months (the interval between the first dose and the second dose was 1-2 months, and the interval between the second dose and the third dose was 6 months or more);
The subjects can understand and voluntarily sign the informed consent form;
Provide legal identification and vaccination certificate of prototype COVID-19 vaccine (CZ strain).

Key exclusion criteria (19 listed)

History of SARS-CoV-2 infection(laboratory confirmed);
Close contact with a confirmed COVID-19 (nucleic acid test or antigen test positive patients)within 14 days prior to randomization;
Received other COVID-19 vaccine in the past except for two or three doses of prototype vaccine;
Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
Autoimmune disease and/or blood disease history (including but not limited to systemic lupus erythematosus, thyroidectomy, autoimmune thyroid disease, any form of malignancy, absence of spleen, functional absence of spleen, or splenectomy for any condition),patients with well-controlled type 1 diabetes can be enrolled;

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
COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)The COVID-19 Vaccine (Vero cell), Inactivated (Omicron variant)was manufactured by Sinovac Research\& Development Co., Ltd.1200SOU inactivated SARS-CoV-2 Omicron strain in 0.5ml of aluminium hydroxide solution per injection.	Biological	Experimental group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）, Experimental group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）, Experimental group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）, Experimental group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）
COVID-19 Vaccine (Vero cell), Inactivated (CZ strain)Also: CoronaVacThe COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.	Biological	Control Group aged 18-59 years and received 2 doses of COVID-19 vaccine（CZ strain）, Control Group aged 18-59 years and received 3 doses of COVID-19 vaccine（CZ strain）, Control Group aged 60 years and above and received 2 doses of COVID-19 vaccine（CZ strain）, Control Group aged 60 years and above and received 3 doses of COVID-19 vaccine（CZ strain）, Historical control group

Primary outcome

Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1)
Time frame: 28 days (Day 28) after booster vaccination
Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of COVID-19 vaccine (Omicron variant), 28 days (Day 28) after booster vaccination among subjects with two- or three-dose COVID-19 vaccine（CZ strain） ≥6 months before
GMTs and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1)
Time frame: 28 days (Day 28) after booster vaccination
GMTs and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), induced by a booster dose of Prototype COVID-19 vaccine, 28 days (Day 28) after booster vaccination among subjects with three-dose Prototype COVID-19 vaccine≥6 months before
GMTs of the neutralizing antibody to SARS-CoV-2 Prototype strain(CZ strain)
Time frame: 28 days after vaccination of two doses of Prototype COVID-19 vaccine
GMTs of the neutralizing antibody to SARS-CoV-2 Prototype strain induced by two doses of Prototype COVID-19 vaccine, 28 days after vaccination in previous clinical trial serums

9 secondary outcomes

Geometric mean increases (GMIs) and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2)
Time frame: 28 days (Day 28) after booster vaccination
GMIs,seroconversion rates seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1), as well as GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.2)
Time frame: 28 days (Day 28) after booster vaccination
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain and Delta strain
Time frame: 28 days (Day 28) after booster vaccination
GMTs, GMIs, seroconversion rates and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain) and Delta strain
Time frame: 28 days (Day 28) after booster vaccination
GMTs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Prototype strain (CZ strain), Delta strain and Omicron strain (BA.1, BA.2)
Time frame: 28 days after primary vaccination
GMTs and seropositive rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1, BA.2), Prototype strain (CZ strain) and Delta strain
Time frame: 3 months (Day 90) and 6 months (Day 180) after booster vaccination
Incidence of local and systemic adverse reactions
Time frame: within 0~7 days after booster vaccination
Incidence of serious adverse events (SAE) and adverse events of special interest (AESI)
Time frame: 12 months after booster vaccination
Incidence of adverse reactions within 0~28 days
Time frame: Within 0~28 days after booster vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
Background: PubMed 37799724Hu J, Liu Y, Liu S, Shu Q, Yang X, Chu K, Qiao Y, Hu Y, Wang K, Pan H. Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial. Front Immunol. 2023 Sep 18;14:1241153. doi: 10.3389/fimmu.2023.1241153. eCollection 2023.

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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.

Hongxing Pan, Master principal investigator

Jiangsu Provincial Center for Disease Prevention and Control

1 site 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 4 inclusion and 19 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: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Geometric mean titres (GMTs) and seroconversion rates of the neutralizing antibody to SARS-CoV-2 Omicron strain (BA.1) (time frame: 28 days (Day 28) after booster 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 NCT05381350, which also lists 1 linked publication.

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 31 May 2024.