NCT04537208View on ClinicalTrials.gov

Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

441

Participants

Timeline

Start Date

September 3, 2020

Primary Completion Date

November 19, 2021

Study Completion Date

November 19, 2021

Conditions
COVID-19 (Healthy Volunteers)
Interventions
BIOLOGICAL

CoV2 preS dTM-AF03 (low-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICAL

CoV2 preS dTM-AF03 (high-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICAL

CoV2 preS dTM-AS03 (low-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICAL

CoV2 preS dTM-AS03 (high-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICAL

CoV2 preS dTM (high-dose) without adjuvant

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICAL

Placebo (0.9% normal saline)

Pharmaceutical form: liquid; route of administration: intramuscular injection

Trial Locations (11)

14609

Investigational Site Number 8400001, Rochester

14642

Investigational Site Number 8400007, Rochester

19104

Investigational Site Number 8400003, Philadelphia

29464

Investigational Site Number 8400014, Mt. Pleasant

32934

Investigational Site Number 8400019, Melbourne

33024

Investigational Site Number 8400011, Hollywood

35294

Investigational Site Number 8400004, Birmingham

44122

Investigational Site Number 8400008, Cleveland

68134

Investigational Site Number 8400002, Omaha

90274

Investigational Site Number 8400012, Rolling Hills Estates

02115

Investigational Site Number 8400016, Boston

Sponsors

Collaborators (1)

GlaxoSmithKline
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT04537208 - Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older | Biotech Hunter | Biotech Hunter