Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

6,300

Participants

Timeline

Start Date

February 6, 2024

Primary Completion Date

May 27, 2026

Study Completion Date

December 7, 2027

Conditions
RSV Immunisation
Interventions
BIOLOGICAL

RSVt Vaccine

Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal

BIOLOGICAL

Placebo

Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal

Trial Locations (130)

1426

Investigational Site Number : 0320006, Buenos Aires

Investigational Site Number : 0320001, Buenos Aires

2001

Investigational Site Number : 7100005, Johannesburg

2013

Investigational Site Number : 7100004, Johannesburg

2193

Investigational Site Number : 7100003, Johannesburg

4000

Investigational Site Number : 0320004, San Miguel de Tucumán

5241

Investigational Site Number : 7100001, East London

7500

Investigational Site Number : 7100008, City of Cape Town

7626

Investigational Site Number : 7100006, Paarl

10400

Investigational Site Number : 7640002, Bangkok

Investigational Site Number : 7640005, Bangkok

10700

Investigational Site Number : 7640004, Bangkok

14090

Investigational Site Number : 4840007, Mexico City

15706

Investigational Site Number : 7240004, Santiago de Compostela

20200

Investigational Site Number : 4040001, Kericho

20520

Investigational Site Number : 2460001, Turku

21900

Investigational Site Number : 5240002, Nepalgunj

28938

Investigational Site Number : 7240003, Móstoles

29406

Palmetto Pediatrics- Site Number : 8400012, North Charleston

29425

Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400036, Charleston

29681

Parkside Pediatrics - Simpsonville- Site Number : 8400071, Simpsonville

30310

Morehouse School of Medicine - Atlanta- Site Number : 8400037, Atlanta

30328

Agile Clinical Research Trials- Site Number : 8400015, Atlanta

30341

Tekton Research, LLC - 4961 Buford Hwy - Georgia - PPDS- Site Number : 8400064, Chamblee

31008

Investigational Site Number : 7240005, Pamplona

31210

Velocity Clinical Research - (Macon - Georgia) - PPDS- Site Number : 8400041, Macon

32829

Accel Research - Nona Pediatric Center- Site Number : 8400068, Orlando

33073

Invictus Clinical Research Group- Site Number : 8400035, Coconut Creek

33100

Investigational Site Number : 2460009, Tampere

33609

TrueBlue Clinical Research- Site Number : 8400065, Tampa

33613

Teena Hughes Pediatrics- Site Number : 8400042, Tampa

35976

Lakeview Clinical Research- Site Number : 8400024, Guntersville

40002

Investigational Site Number : 7640003, Khon Kaen

40100

Investigational Site Number : 4040002, Kisumu

Investigational Site Number : 4040003, Kisumu

41013

Investigational Site Number : 7240002, Seville

44121

Senders Pediatrics- Site Number : 8400006, South Euclid

44600

Investigational Site Number : 5240001, Kathmandu

45210

Investigational Site Number : 5240003, Dhulikhel N.p

45229

Cincinnati Children's Hospital Medical Center- Site Number : 8400063, Cincinnati

48075

Great Lakes Research Institute- Site Number : 8400060, Southfield

48101

Michigan Institute of Research- Site Number : 8400055, Allen Park

48127

Vida Clinical Studies - Dearborn Heights- Site Number : 8400072, Dearborn Heights

50101

Investigational Site Number : 4040007, Butere

50180

Investigational Site Number : 7640001, Chiang Mai

55402

Clinical Research Institute - Minneapolis- Site Number : 8400011, Minneapolis

59405

Boeson Research - Great Falls- Site Number : 8400008, Great Falls

60100

Investigational Site Number : 2460006, Seinäjoki

64060

Investigational Site Number : 4840008, Monterrey

67100

Investigational Site Number : 2460004, Kokkola

68114

Quality Clinical Research - Omaha - Regency Circle- Site Number : 8400016, Omaha

68134

Velocity Clinical Research - Omaha- Site Number : 8400054, Omaha

68516

Be Well Clinical Studies - Lincoln- Site Number : 8400058, Lincoln

68901

Velocity Clinical Research - Hastings- Site Number : 8400017, Hastings

76104

Ventavia Research Group - Fort Worth- Site Number : 8400022, Fort Worth

77057

Private Practice - Dr. Chinyere N. Awa- Site Number : 8400066, Houston

77065

DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400044, Houston

77469

Pediatric Center - Richmond- Site Number : 8400019, Richmond

77573

Maximos Ob/Gyn- Site Number : 8400023, League City

78244

Tekton Research - FM78- Site Number : 8400067, San Antonio

83404

Clinical Research Prime- Site Number : 8400013, Idaho Falls

Leavitt Women's Healthcare- Site Number : 8400033, Idaho Falls

Snake River Research- Site Number : 8400046, Idaho Falls

83406

Medical Research Partners - Ammon- Site Number : 8400059, Ammon

84041

Alliance for Multispecialty Research - Layton - North Robins Drive- Site Number : 8400030, Layton

84067

Wee Care Pediatrics - Roy- Site Number : 8400002, Roy

84075

Wee Care Pediatrics - Syracuse- Site Number : 8400004, Syracuse

90110

Investigational Site Number : 7640006, Hat Yai

90220

Investigational Site Number : 2460002, Oulu

91356

Integrated Clinical Research- Site Number : 8400056, Tarzana

91910

Investigational Site Number : 4840004, Veracruz

93637

Madera Family Medical Group- Site Number : 8400029, Madera

97030

Cyn3rgy Research- Site Number : 8400014, Gresham

221699

Investigational Site Number : 1560009, Jiangsu

250001

Investigational Site Number : 1700002, Chía

252431

Investigational Site Number : 1700003, Girardot

507001

Investigational Site Number : 1700004, Acacías

5480000

Investigational Site Number : 1520005, Port Montt

8331143

Investigational Site Number : 1520004, Santiago

8380418

Investigational Site Number : 1520001, Santiago

35205-1628

Central Research Associates - Flourish - PPDS- Site Number : 8400009, Birmingham

85741-2306

Novak Clinical Research- Site Number : 8400069, Tucson

92395-8306

National Institute of Clinical Research - Victorville - ClinEdge - PPDS- Site Number : 8400040, Victorville

33122-1088

Site Number : 8400031, Doral

30322-1014

Emory-Children's Center- Site Number : 8400001, Atlanta

31405-5701

iResearch Savannah - CenExel - PPDS- Site Number : 8400032, Savannah

68701-2669

Velocity Clinical Research (Norfolk - Nebraska) - PPDS- Site Number : 8400038, Norfolk

10456-2102

Prime Global Research, Inc.- Site Number : 8400043, The Bronx

37203-2066

Clinical Research Associates Inc- Site Number : 8400005, Nashville

77706-3061

Tekton Research, LLC - Beaumont - PPDS- Site Number : 8400061, Beaumont

78840-3927

South Texas Urgent Care - Del Rio- Site Number : 8400062, Del Rio

C1425

Investigational Site Number : 0320007, Buenos Aires

X5800

Investigational Site Number : 0320003, Río Cuarto

S2013DTC

Investigational Site Number : 0320005, Rosario

T4000

Investigational Site Number : 0320002, San Miguel de Tucumán

41680-020

Associação Obras Sociais Irmã Dulce - Centro de Pesquisa ClÃ-nica (CPEC)- Site Number : 0760009, Salvador

30150-320

Freire Pesquisa Clínica- Site Number : 0760001, Belo Horizonte

90035-903

Hospital de Clinicas de Porto Alegre- Site Number : 0760005, Porto Alegre

90160-093

Hospital Ernesto Dornelles- Site Number : 0760007, Porto Alegre

14015-010

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS- Site Number : 0760010, Ribeirão Preto

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006, São José do Rio Preto

04023-062

Hospital São Paulo da Universidade Federal de Sao Paulo - Escola Paulista de Medicina UNIFESP-EPM- Site Number : 0760002, SãO Paulo

04265-000

Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004, São Paulo

02230

Investigational Site Number : 2460003, Espoo

00100

Investigational Site Number : 2460005, Helsinki

04400

Investigational Site Number : 2460008, Järvenpää

063-0841

Investigational Site Number : 3920011, Sapporo

350-0001

Investigational Site Number : 3920007, Kawagoe

420-0005

Investigational Site Number : 3920010, Shizuoka-Shi Aoi-Ku

133-0056

Investigational Site Number : 3920006, Edogawa-Ku

910-0833

Investigational Site Number : 3920001, Fukui

910-0808

Investigational Site Number : 3920002, Fukui-shi

813-0036

Investigational Site Number : 3920004, Fukuoka

890-0034

Investigational Site Number : 3920003, Kagoshima

816-0801

Investigational Site Number : 3920005, Kasuga-Shi

820-0040

Investigational Site Number : 3920008, Lizuka-shi

556-0005

Investigational Site Number : 3920009, Osaka

KENYA

Investigational Site Number : 4040006, Nairobi

00961-7041

Clinical Research Investigator Group- Site Number : 6300001, Bayamón

00784

Clinical Research Puerto Rico (CRPR), Inc. - Guayama- Site Number : 6300005, Guayama

00918

Caribbean Medical Research Center- Site Number : 6300003, San Juan

00923

Hospital Pediatrico Universitario- Site Number : 6300002, San Juan

0250

Investigational Site Number : 7100007, Brits

0122

Investigational Site Number : 7100002, Pretoria

0152

Investigational Site Number : 7100009, Soshanguve

08023

Investigational Site Number : 7240001, Barcelona

TR27 5DT

Investigational Site Number : 8260003, Hayle

EX2 5DW

Investigational Site Number : 8260005, Exeter

SO16 6YD

Investigational Site Number : 8260007, Southampton

BS1 3NU

Investigational Site Number : 8260004, Bristol

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY