Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

3,159

Participants

Timeline

Start Date

February 24, 2021

Primary Completion Date

June 29, 2023

Study Completion Date

June 29, 2023

Conditions
COVID-19
Interventions
BIOLOGICAL

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03

Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection

Trial Locations (66)

2145

Investigational Site Number : 0360005, Westmead

3010

Investigational Site Number : 5540001, Rotorua

3243

Investigational Site Number : 5540007, Nawton

4101

Investigational Site Number : 0360001, South Brisbane

4215

Investigational Site Number : 0360002, Southport

5011

Investigational Site Number : 0360004, Woodville

5067

Investigational Site Number : 0360003, Norwood

7011

Investigational Site Number : 5540010, Nelson

8013

Investigational Site Number : 5540002, Christchurch

10016

New York University Langone Vaccine Center Site Number : 8400230, New York

10032

Columbia University Irving Medical Center Site Number : 8400203, New York

11101

Investigational Site Number : 3400002, Municipio Del Distrito Central

11220

NYU VC-Augustana Site Number : 8400267, Brooklyn

13005

Investigational Site Number : 2500015, Marseille

Investigational Site Number : 2500016, Marseille

14642

University of Rochester Site Number : 8400207, Rochester

15213

University of Pittsburgh Site Number : 8400233, Pittsburgh

15706

Investigational Site Number : 7240013, Santiago de Compostela

20037

The George Washington University Site Number : 8400212, Washington D.C.

20850

Optimal Research, LLC Rockville Site Number : 8400048, Rockville

21079

Investigational Site Number : 2500013, Dijon

21104

Investigational Site Number : 3400001, San Pedro Sula

28041

Investigational Site Number : 7240009, Madrid

28222

Investigational Site Number : 7240016, Majadahonda

29405

Coastal Carolina Research Center Site Number : 8400097, North Charleston

30030

Emory University Decatur Site Number : 8400201, Decatur

32806

Synexus Clinical Research US, Inc. - Orlando Site Number : 8400179, Orlando

32934

Optimal Research, LLC Site Number : 8400057, Melbourne

33024

Cenexel Research Centers of America Site Number : 8400089, Hollywood

33600

Investigational Site Number : 2500003, Pessac

35033

Investigational Site Number : 2500004, Rennes

35205

Synexus - Clinical Research Advantage, Inc. Site Number : 8400270, Birmingham

36312

Investigational Site Number : 7240003, Vigo

37044

Investigational Site Number : 2500002, Tours

44093

Investigational Site Number : 2500006, Nantes

46020

Investigational Site Number : 7240008, Valencia

47714

Synexus Clinical Research Evansville Site Number : 8400272, Evansville

57701

American Indian Clinical Trials Research Network Site Number : 8400204, Rapid City

60607

Chicago Clinical Research Institute, Inc. Site Number : 8400269, Chicago

61614

Optimal Research Site Number : 8400187, Peoria

63141

Synexus St. Louis Site Number : 8400100, St Louis

68134

Velocity Clinical Research, Omaha Site Number : 8400030, Omaha

69004

Investigational Site Number : 2500014, Lyon

69495

Investigational Site Number : 2500007, Pierre-Bénite

70125

Research Works INC Site Number : 8400045, New Orleans

72205

Baptist Health Center for Clinical Research Site Number : 8400077, Little Rock

75679

Investigational Site Number : 2500005, Paris

78744

AES Austin Site Number : 8400191, Austin

85225

Synexus Chandler Site Number : 8400251, Chandler

85306

Synexus - Glendale. Site Number : 8400271, Glendale

87042

Investigational Site Number : 2500008, Limoges

90059

Charles R. Drew University of Medicine and Science Site Number : 8400220, Los Angeles

90274

Peninsula Research Associates, Inc. Site Number : 8400094, Rolling Hills Estates

92108

Optimal Research Site Number : 8400173, San Diego

06510

Yale University Site Number : 8400239, New Haven

02115

Brigham and Women's Hospital Site Number : 8400199, Boston

07666

Holy Name Medical Center Site Number : 8400072, Teaneck

0600

Investigational Site Number : 5540005, New Lynn

WA7 2DA

Investigational Site Number : 8260011, Runcorn

BA1 3NG

Investigational Site Number : 8260017, Bath

SM2 5PT

Investigational Site Number : 8260013, Surrey

DN4 8QN

Investigational Site Number : 8260014, Doncaster

GL1 3NN

Investigational Site Number : 8260016, Gloucester

HA1 3UJ

Investigational Site Number : 8260010, Harrow

SW10 0LR

Investigational Site Number : 8260015, London

SO16 6YD

Investigational Site Number : 8260012, Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY