A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19)

NCT04852705 | Unknown Phase 3 DMC

• 1 other identifier: 2021L001
• Study Type: interventional
• Target: 28,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence density of symptomatic COVID-19 cases

  Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.

  14 days after full vaccination

Secondary Outcomes (15)

• Incidence density of COVID-19 moderate cases and above

  14 days after full vaccination

• Incidence density of COVID-19 severe cases and above

  14 days after full vaccination

• Incidence density of COVID-19 death cases and above

  14 days after full vaccination

• Incidence density of symptomatic COVID-19 cases in different age groups

  14 days after full vaccination

• Incidence of solicited local adverse events

  0-7 days after each vaccination

Study Arms (2)

candidate vaccine

EXPERIMENTAL

Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

SARS-CoV-2 Vaccine (Vero Cells), Inactivated BIOLOGICAL

2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.

candidate vaccine

Placebo BIOLOGICAL

2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms.
• Be able to understand and comply with study requirements/ procedures.
• Participants with negative results of SARS-CoV-2 Realtime-PCR (RT-PCR) detection.
• For females or sex-partners of males at childbearing age: be willing to use birth control for 3 months after the 2nd dose.
• For females of childbearing potential (Pausimenia ≤ 2 years ) must: have a negative urine or blood pregnancy test at screening
• Axillary temperature \< 37.3℃/99.1℉ when screening (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).

You may not qualify if:

• Previous treatments for curing or preventing COVID-19 (including vaccination of various COVID-19 vaccines).
• History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
• History of allergy to any components of the candidate vaccine or severe allergic reactions to vaccine or medicine (including, but not limited to, allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrosis (Arthus reaction)).
• Positive for HIV detection.
• History or family history of convulsion, epilepsy, encephalopathy, and psychosis.
• Active stage of malignancies, malignancies without adequate treatments, malignancies with potential risk for recurrence during the study.
• Severe or uncontrolled cardiovascular, neurological, blood and lymphatic, kidney, liver, respiratory, metabolic and skeletal diseases.
• Congenital or functional absence of spleen, complete or partial removal of spleen in any case.
• Chronic administration (defined as ≥ 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the 1st vaccination (eg. corticosteroids, ≥ 0.5 mg/kg/day prednisone or equivalent; but, inhaled and topical steroids are allowed).
• Planned administration/administration of a vaccine not foreseen by the study protocol less than 7 days before 1st dose of candidate vaccine for inactivated vaccines or 14 days before 1st dose of candidate vaccine for attenuated live vaccines.
• Receipt of blood products and/or immunoglobulins within 3 months prior to enrollment or expected receipt during the study.
• Donate or loss ≥ 450 ml of blood within 1 month prior to enrollment, or expected blood donation during the study.
• Fever: axillary temperature ≥ 37.3℃/99.1℉ within the past 24 hours (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
• Those who participated in other clinical trials 1 month prior to the enrollment or used any investigational or non-registered drug during the study period; Those who are unable to finish follow-up or fail in efficacy assessments.
• Breastfeeding females should not be included.

Sponsors & Collaborators

• Shenzhen Kangtai Biological Products Co., LTD: lead
• Beijing Minhai Biotechnology Co., Ltd: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Guifan Li, M.S

CONTACT

+861059613591; liguifan@biominhai.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: May 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: April 22, 2021

Record last verified: 2021-04