Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

PHASE3CompletedINTERVENTIONAL
Enrollment

23,726

Participants

Timeline

Start Date

August 20, 2020

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
COVID-19
Interventions
BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series)

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection

BIOLOGICAL

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

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

BIOLOGICAL

Placebo

Pharmaceutical form: liquid. Route of administration: intramuscular administration.

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

BIOLOGICAL

SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination

Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.

Trial Locations (86)

0

Investigational Site Number : 8000002, Entebbe

Investigational Site Number : 8000005, Entebbe

Investigational Site Number : 8000001, Kampala

114

Investigational Site Number : 2880001, Navrongo

10101

Investigational Site Number : 8000013, Kampala

Investigational Site Number : 8000014, Lira

11101

Investigational Site Number : 3400001, Municipio Del Distrito Central

14609

Rochester Clinical Research, Inc. Site Number : 8400023, Rochester

21104

Investigational Site Number : 3400002, San Pedro Sula

21900

Investigational Site Number : 5240001, Nepalgunj

23491

Investigational Site Number : 8000007, Kampala

29405

Coastal Carolina Research Center - N Charleston Site Number : 8400022, North Charleston

29621

Synexus Clinical Research Anderson Site Number : 8400007, Anderson

30100

Investigational Site Number : 4040006, Eldoret

30328

Synexus Clinical Research US, Inc. - Atlanta Site Number : 8400005, Atlanta

32806

Synexus Clinical Research US, Inc. - Orlando Site Number : 8400020, Orlando

32934

Optimal Research, LLC Site Number : 8400002, Melbourne

33781

AES St. Petersburg Site Number : 8400017, Pinellas Park

35211

AES - DRS - Simon Williamson Clinic, PC - Birmingham Site Number : 8400004, Birmingham

35802

Optimal Research Alabama Site Number : 8400019, Huntsville

37000

Investigational Site Number : 4840005, León

39670

Investigational Site Number : 4840004, Acapulco de Juárez

40100

Investigational Site Number : 4040002, Kisumu

Investigational Site Number : 4040003, Kisumu

43212

Synexus US Columbus Site Number : 8400011, Columbus

44280

Investigational Site Number : 4840003, Guadalajara

44311

Synexus Akron Site Number : 8400009, Akron

44600

Investigational Site Number : 5240003, Kathmandu

45200

Investigational Site Number : 5240002, Dhulikhel

45236

Synexus Clinical Research US, Inc. - Cincinnati Site Number : 8400010, Cincinnati

47714

Synexus Clinical Research Evansville Site Number : 8400008, Evansville

50101

Investigational Site Number : 4040011, Butere

57701

American Indian Clinical Trials Research Network Site Number : 8400025, Rapid City

60602

Synexus Clinical Research Chicago Site Number : 8400012, Chicago

62290

Investigational Site Number : 4840008, Cuernavaca

62587

Investigational Site Number : 4840006, Temixco

63141

Synexus St. Louis Site Number : 8400006, St Louis

75231

Synexus Dallas Site Number : 8400014, Dallas

76001

Investigational Site Number : 1700005, Santiago de Cali

78229

Synexus Clinical Research US, Inc. - San Antonio Site Number : 8400015, San Antonio

78744

AES Austin Site Number : 8400003, Austin

80112

Synexus Clinical Research US, Inc. Site Number : 8400013, Centennial

84123

AES Salt Lake City Site Number : 8400016, Murray

89052

Synexus Clinical Research US, Inc. - Henderson Site Number : 8400018, Henderson

90274

Peninsula Research Associates, Inc. Site Number : 8400021, Rolling Hills Estates

91910

Investigational Site Number : 4840002, Veracruz

111611

Investigational Site Number : 1700001, Bogotá

208002

Investigational Site Number : 3560005, Kanpur

252431

Investigational Site Number : 1700007, Girardot

302039

Investigational Site Number : 3560001, Jaipur

305001

Investigational Site Number : 3560010, Ajmer

380015

Investigational Site Number : 3560002, Ambawadi

440001

Investigational Site Number : 3560009, Nagpur

500082

Investigational Site Number : 3560003, Punjagutta

590002

Investigational Site Number : 3560007, Belagavi

603203

Investigational Site Number : 3560006, Tamilnadu

630001

Investigational Site Number : 1700015, Quindío

681004

Investigational Site Number : 1700004, Floridablanca

751003

Investigational Site Number : 3560011, Odisha

801507

Investigational Site Number : 3560004, Patna

856018

Investigational Site Number : 1700010, Aguazul

080020

Investigational Site Number : 1700002, Barranquilla

Investigational Site Number : 1700008, Barranquilla

0000

Investigational Site Number : 1700006, Chía

Investigational Site Number : 1700009, Meta

083001

Investigational Site Number : 1700003, Soledad

P. O. Box 200

Investigational Site Number : 2880002, Kintampo

00000

Investigational Site Number : 2880003, Kumasi

101-0041

Investigational Site Number : 3920005, Chiyoda-ku,

162-0053

Investigational Site Number : 3920004, Haramachi,Shinjuku-ku

166-0003

Investigational Site Number : 3920003, Kouenji minami,Suginami-ku

104-0031

Investigational Site Number : 3920001, Kyobashi Chuo-ku

143-0015

Investigational Site Number : 3920002, Ohta-ku

00200

Investigational Site Number : 4040004, Kericho

40123 Kisumu

Investigational Site Number : 4040012, Kisumu

80107 Ganjoni

Investigational Site Number : 4040008, Mombasa

00100GPO

Investigational Site Number : 4040001, Nairobi

00100

Investigational Site Number : 4040007, Nairobi

00202 Kiambu

Investigational Site Number : 4040009, Thika

04530

Investigational Site Number : 4840009, Mexico City

42 Nakasero Road

Investigational Site Number : 8000003, Kampala

Plot 101, Lubowa

Investigational Site Number : 8000004, Kampala

04210

Investigational Site Number : 8040002, Kiev

01023

Investigational Site Number : 8040004, Kyiv

02002

Investigational Site Number : 8040003, Kyiv

03037

Investigational Site Number : 8040001, Kyiv

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT04904549 - Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older | Biotech Hunter | Biotech Hunter