Status unknownNCT04852705Updated Apr 22, 2021

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)

A Phase 3 interventional study of SARS-CoV-2 Vaccine (Vero Cells), Inactivated and Placebo in COVID-19, sponsored by Shenzhen Kangtai Biological Products Co., LTD. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-22.

Sponsored by Shenzhen Kangtai Biological Products Co., LTD · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 28,000
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

COVID-19

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COVID-19 7,640

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 28,000 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Shenzhen Kangtai Biological Products Co., LTD is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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 ).

Exclusion criteria

Exclusion Criteria:

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.
Ineligible for the study based on the assessment of investigator.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 28,000 participants (estimated)

Study arms

Experimental
candidate vaccine
Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated
Placebo comparator
Placebo
Biological: Placebo

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

Incidence density of COVID-19 moderate cases and above
Incidence density of COVID-19 moderate cases and above occurring from 14 days after full vaccination.
Time frame: 14 days after full vaccination
Incidence density of COVID-19 severe cases and above
Incidence density of COVID-19 severe cases and above occurring from 14 days after full vaccination.
Time frame: 14 days after full vaccination
Incidence density of COVID-19 death cases and above
Incidence density of COVID-19 death cases and above occurring from 14 days after full vaccination.
Time frame: 14 days after full vaccination
Incidence density of symptomatic COVID-19 cases in different age groups
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination in different age groups (18\~59 years and ≥ 60 years).
Time frame: 14 days after full vaccination
Incidence of solicited local adverse events
Incidence of solicited local adverse events occurring 0-7 days after each vaccination.
Time frame: 0-7 days after each vaccination
Incidence of solicited general adverse events
Incidence of solicited general adverse events occurring 0-7 days after each vaccination.
Time frame: 0-7 days after each vaccination
Incidence of unsolicited adverse events
Incidence of unsolicited adverse events occurring 0-28 days after each vaccination.
Time frame: 0-28 days after each vaccination
Incidence of SAE
Incidence of SAE occurring from the 1st dose through the end of study.
Time frame: from the 1st dose through the end of study
Incidence of AESI
Incidence of AESI occurring from the 1st dose through the end of study.
Time frame: from the 1st dose through the end of study
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 neutralizing antibody
geometric mean titer of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Seroconversion rate of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Geometric mean titer of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time frame: 28 days, 90 days, 180 days and 360 days after full vaccination

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04852705
Lead sponsor: Shenzhen Kangtai Biological Products Co., LTD
Collaborators: Beijing Minhai Biotechnology Co., Ltd
Responsible party: Sponsor
First posted: Apr 21, 2021
Start date: May 2021 (estimated)
Primary completion: Nov 2021 (estimated)
Completion: Nov 2022 (estimated)
Last update: Apr 22, 2021

Study contacts

Guifan Li, M.S

Contact

liguifan@biominhai.com

+861059613591

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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