WHO ICTRP trial

A controlled Phase 2/3 study of adjuvanted recombinant SARS-CoV-2 trimeric…

EUCTR2020-004272-17-BE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2020-004272-17-BE
Public title A controlled Phase 2/3 study of adjuvanted recombinant SARS-CoV-2 trimeric S-protein vaccine (SCB-2019) for the prevention of COVID-19
Scientific title A Double-blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of CpG 1018/Alum-Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) for the Prevention of SARS-CoV-2-mediated COVID-19 in Participants Aged 12 years and Older…
Primary sponsor Clover Biopharmaceuticals AUS Pty Ltd
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Colombia;Belgium;Philippines;Brazil;South Africa;Germany
Conditions SARS-CoV-2-mediated COVID-19 MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Interventions Product Name: SCB-2019 (CpG 1018/Alum-djuvanted SCB-2019) Product Code: SCB-2019 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available Current Sponsor code: SCB-2019 Other descriptive name: SARS-CoV-2 spike trimer…
Registration date Nov 18, 2020
Target size 30000
Secondary IDs CLO-SCB-2019-003
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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