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COVID-19Phase 3COVID-19NCT04510207

A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above

A Phase 3 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell) in people with COVID-19, run by China National Biotec Group Company Limited at 6 sites in 4 countries.

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

This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Inactivated SARS-CoV-2 Vaccine (Vero cell)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44,101 participants
Where
6 sitesin 4 countries
Study dates
16 Jul 2020to 31 Dec 2021
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.
  • 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 3 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 acute cases of SARS-CoV-2 Infection.
  • Have a history of SARS, MERS infection (self-report, on-site inquiry).
  • Positive urine pregnancy test result.
  • Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
  • Axillary body temperature > 37.0 ℃ 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.
Show all 18Show fewer
  • Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
  • With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • With severe liver diseases, severe kidney diseases defined as eGFR less than 60, uncontrollable hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure > 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
  • Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
  • With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
  • Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
  • Receiving anti-TB therapy.
  • Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
  • Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
  • Received blood products within 3 months before this vaccination
  • Received other research drugs within 6 months before this vaccination.
  • Other circumstances judged by investigators that are not suitable for this clinical trial.

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

Egypt2 sites

  • Katameya Medical Center

    Cairo, 11835

  • Vacsera health Care facilities , MoH

    Cairo, 22311

Other trials in Egypt

United Arab Emirates2 sites

  • Sheikh Khalifa Medical City, SEHA

    Abu Dhabi, 51900

  • Al Qarain Primary Health Care Centre-MOHAP

    Sharjah city, 61545

Other trials in United Arab Emirates

Bahrain1 site

  • Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S

    Sanābis

Other trials in Bahrain

Jordan1 site

  • Prince Hamza Hospital

    Amman

Other trials in Jordan

About this study

Official title: Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above

This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 \& D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months

Conditions
COVID-19
Being tested
Inactivated SARS-CoV-2 Vaccine (Vero cell), Placebo
Keywords
SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

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

  • Inactivated SARS-CoV-2 Vaccine (Vero cell)Biological

    The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP

  • Inactivated SARS-CoV-2 Vaccine (Vero cell)Biological

    The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP

  • PlaceboBiological

    The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP

Study groups in NCT04510207
Study groupRoleWhat they receive
Investigational Vaccine 1ExperimentalParticipants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 \& D21.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Investigational Vaccine 2ExperimentalParticipants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 \& D21.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
PlaceboPlacebo comparatorParticipants will receive 2 doses of Placebo according to the immunization schedule of D0 \& D21.
Receives: Biological: Placebo
Investigational Vaccine 1bExperimentalParticipants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP after 3 months following two doses of immunization.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Investigational Vaccine 2bExperimentalParticipants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP after 3 months following two doses of immunization.
Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Placebo-bPlacebo comparatorParticipants will receive a booster dose of Placebo after 3 months following two doses of immunization.
Receives: Biological: Placebo

What is being measured

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

  1. The incidence of COVID-19 cases after two-doses of vaccination

    Measured: From14 days after the second dose to 6 month after the second dose

  2. The incidence of COVID-19 cases after the booster dose of immunization

    Measured: From 14 days after the booster dose

Secondary outcomes (13)

  1. The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination

    Measured: From 14 day after the second dose to 6 month after the second dose

  2. The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination

    Measured: From 14 day after the booster dose

  3. The incidence of any adverse reactions/events

    Measured: 28 days after each immunization

  4. The incidence of serious adverse events (SAE)

    Measured: From the beginning of the first dose to 12 months after the second immunization

  5. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days after full course of immunization

  6. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days after full course of immunization

  7. The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days after full course of immunization

  8. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

  9. The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    Measured: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

  10. The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization

  11. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days, 28 days and 6th month after the booster dose

  12. The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days, 28 days and 6th month after the booster dose

  13. The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody

    Measured: 14 days, 28 days and 6th month after the booster dose

Timeline

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

  1. First posted12 Aug 2020
  2. Study start16 Jul 2020
  3. Primary completion16 Jun 2021
  4. Study completion31 Dec 2021

Resources

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
44,101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510207
Sponsor's protocol ID
CNBG2020003SQ
Acronym
COVID-19
Status last verified
Jun 2023
First submitted
3 Aug 2020
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Al Kaabi N, Yang Y, Eldin Hussein S, Yang T, Abdalla J, Wang H, Lou Z, Chinese Center For Disease Control And Prevention, Bakkour A, Arafat A, China National Biotec Group Company Limited, Jiang Z, Tian Y, National Engineering Technology Research Center For Combined Vaccines Wuhan Institute Of Biological Products Co Ltd, Beijing Institute Of Biological Products Company Limited, Xiao P, Zaher W, Eltantawy I, Wang C, Xu G, Zhang Y, Yang X. Efficacy and Safety of a Booster Vaccination with Two Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: Results of a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial in Abu Dhabi. Vaccines (Basel). 2023 Jan 30;11(2):299. doi: 10.3390/vaccines11020299.

    PubMed 36851177

  • Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.

    PubMed 35464483

  • Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin Fasihuddin M, You W, Xie Z, Zhao Y, Jiang Z, Zhao G, Zhang Y, Mahmoud S, ElTantawy I, Xiao P, Koshy A, Zaher WA, Wang H, Duan K, Pan A, Yang X. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):35-45. doi: 10.1001/jama.2021.8565.

    PubMed 34037666

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell) in people with COVID-19, run by China National Biotec Group Company Limited at 6 sites in 4 countries.

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 5 inclusion and 18 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 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 6 sites in Egypt, United Arab Emirates, Bahrain, Jordan. 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. Some participants in this study may receive a placebo. 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?

The incidence of COVID-19 cases after two-doses of vaccination (time frame: From14 days after the second dose to 6 month after the second dose). The study lists 2 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 NCT04510207, which also lists 3 linked publications.

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.

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