NCT04510207

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44,101

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started Jul 2020

Typical duration for phase_3 covid19

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

August 3, 2020

Last Update Submit

June 15, 2023

Conditions

COVID-19

Keywords

SARS-CoV-2SARS-CoV-2 VaccineCoronavirus

Outcome Measures

Primary Outcomes (2)

  • The incidence of COVID-19 cases after two-doses of vaccination

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

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

    From 14 days after the booster dose

Secondary Outcomes (13)

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

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

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

    From 14 day after the booster dose

  • The incidence of any adverse reactions/events

    28 days after each immunization

  • The incidence of serious adverse events (SAE)

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

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

    14 days after full course of immunization

  • +8 more secondary outcomes

Other Outcomes (2)

  • the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19

    14 days after 2 doses of vaccination

  • The occurrence of ADE

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

Study Arms (6)

Investigational Vaccine 1

EXPERIMENTAL

Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 \& D21.

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

Investigational Vaccine 2

EXPERIMENTAL

Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 \& D21.

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

Placebo

PLACEBO COMPARATOR

Participants will receive 2 doses of Placebo according to the immunization schedule of D0 \& D21.

Biological: Placebo

Investigational Vaccine 1b

EXPERIMENTAL

Participants 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.

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

Investigational Vaccine 2b

EXPERIMENTAL

Participants 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.

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

Placebo-b

PLACEBO COMPARATOR

Participants will receive a booster dose of Placebo after 3 months following two doses of immunization.

Biological: Placebo

Interventions

Inactivated SARS-CoV-2 Vaccine (Vero cell)BIOLOGICAL

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

Investigational Vaccine 1Investigational Vaccine 1b
PlaceboBIOLOGICAL

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

PlaceboPlacebo-b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Sanābis, Bahrain

Location

Katameya Medical Center

Cairo, 11835, Egypt

Location

Vacsera health Care facilities , MoH

Cairo, 22311, Egypt

Location

Prince Hamza Hospital

Amman, Jordan

Location

Sheikh Khalifa Medical City, SEHA

Abu Dhabi, 51900, United Arab Emirates

Location

Al Qarain Primary Health Care Centre-MOHAP

Sharjah city, 61545, United Arab Emirates

Location

Related Publications (3)

  • 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.

    PMID: 36851177DERIVED

  • 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.

    PMID: 35464483DERIVED

  • 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.

    PMID: 34037666DERIVED

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

SARS-CoV-2 inactivated vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Walid A Zaher, MD, MSc,PhD

    G42 Healthcare company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 12, 2020

Study Start

July 16, 2020

Primary Completion

June 16, 2021

Study Completion

December 31, 2021

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)JO(1)AE(2)BA(1)