NCT04412538 is a Phase 1, PHASE2 clinical trial of Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule in COVID-19, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences.

Who is sponsoring NCT04412538?

NCT04412538 is sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences.

What drugs are being tested in NCT04412538?

Interventions in NCT04412538: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule, High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule, High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule, Placebo on a 0- and 28-day schedule, Placebo on a 0- and 14-day schedule.

Is NCT04412538 still recruiting?

NCT04412538 is currently completed. Last updated 11 October 2023.

Last reviewed 2023-10-11 · How we verify

NCT04412538

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19

Completed Phase 1, PHASE2 Last updated 11 October 2023

What this trial tests

Phase 1, PHASE2 trial testing Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule in COVID-19 in 942 participants. Completed in 31 August 2021.

Timeline

15 May 2020

Primary endpoint
10 August 2020

31 August 2021

Quick facts

Lead sponsor	Institute of Medical Biology, Chinese Academy of Medical Sciences
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	942
Start date	15 May 2020
Primary completion	10 August 2020
Estimated completion	31 August 2021
Sites	1 location across China

Drugs / interventions tested

Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule — full drug profile →
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule — full drug profile →
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule — full drug profile →
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule — full drug profile →
Placebo on a 0- and 28-day schedule — full drug profile →
Placebo on a 0- and 14-day schedule

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Who can join

Adults 18 to 59, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged 18\~59 Years.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Progress of the COVID-19 vaccine effort: viruses, vaccines and variants versus efficacy, effectiveness and escape.
Tregoning JS, Flight KE, Higham SL, Wang Z, et al · · 2021 · cited 827× · PMID 34373623 · DOI 10.1038/s41577-021-00592-1
Immunological considerations for COVID-19 vaccine strategies.
Jeyanathan M, Afkhami S, Smaill F, Miller MS, et al · · 2020 · cited 697× · PMID 32887954 · DOI 10.1038/s41577-020-00434-6
COVID-19 vaccines: rapid development, implications, challenges and future prospects.
Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
Efficacy and safety of COVID-19 vaccines.
Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
Impact of COVID-19 on the social, economic, environmental and energy domains: Lessons learnt from a global pandemic.
Mofijur M, Fattah IMR, Alam MA, Islam ABMS, et al · · 2021 · cited 214× · PMID 33072833 · DOI 10.1016/j.spc.2020.10.016
Vaccines for COVID-19.
Tregoning JS, Brown ES, Cheeseman HM, Flight KE, et al · · 2020 · cited 154× · PMID 32935331 · DOI 10.1111/cei.13517
Evaluation of the safety profile of COVID-19 vaccines: a rapid review.
Wu Q, Dudley MZ, Chen X, Bai X, et al · · 2021 · cited 151× · PMID 34315454 · DOI 10.1186/s12916-021-02059-5
COVID-19 vaccine: where are we now and where should we go?
Soleimanpour S, Yaghoubi A. · · 2021 · cited 98× · PMID 33435774 · DOI 10.1080/14760584.2021.1875824

Verify or expand the search:

Other trials of Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule

Trials testing the same drug.

NCT04470609 — Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 · Phase 1, PHASE2 · completed

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Institute of Medical Biology, Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

NCT07418372 — Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine · Phase 1, PHASE2 · not yet recruiting
NCT07326878 — Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine · Phase 1 · not yet recruiting
NCT07144202 — Study on the Persistence of Immunity Following EV71 Vaccination · enrolling by invitation
NCT06920069 — Study of Concomitant Administration of the sIPV and DTaP or MMR · Phase 4 · not yet recruiting
NCT06800950 — Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04412538 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institute of Medical Biology, Chinese Academy of Medical Sciences
Last refreshed: 11 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04412538.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing