Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
NCT ID: NCT06252285
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
6300 participants
INTERVENTIONAL
2024-02-06
2027-12-07
Brief Summary
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Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo.
Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
* No blinding for study staff who prepare and administer the study interventions
Study Groups
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Group 1 RSVt Vaccine
Participants will receive 2 intranasal administrations of RSVt vaccine
RSVt Vaccine
Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal
Group 2 Control
Participants will receive 2 intranasal administrations of placebo
Placebo
Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal
Interventions
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RSVt Vaccine
Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal
Placebo
Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Born at full term of pregnancy (≥ 37 weeks)
Exclusion Criteria
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* History of medically diagnosed wheezing
* Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
* Member of a household that contains an immunocompromised individual, including, but not limited to:
* a person who is HIV infected
* a person who has received chemotherapy within the 12 months prior to study enrollment
* a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
* a person living with a solid organ or bone marrow transplant
* Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator's discretion
* Participant's biological mother's previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding.
* Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration:
* Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration
* Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed.
* Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
* Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
6 Months
21 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Locations
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Central Research Associates - Flourish - PPDS- Site Number : 8400009
Birmingham, Alabama, United States
Lakeview Clinical Research- Site Number : 8400024
Guntersville, Alabama, United States
Novak Clinical Research- Site Number : 8400069
Tucson, Arizona, United States
Madera Family Medical Group- Site Number : 8400029
Madera, California, United States
Integrated Clinical Research- Site Number : 8400056
Tarzana, California, United States
National Institute of Clinical Research - Victorville - ClinEdge - PPDS- Site Number : 8400040
Victorville, California, United States
Invictus Clinical Research Group- Site Number : 8400035
Coconut Creek, Florida, United States
Site Number : 8400031
Doral, Florida, United States
Accel Research - Nona Pediatric Center- Site Number : 8400068
Orlando, Florida, United States
TrueBlue Clinical Research- Site Number : 8400065
Tampa, Florida, United States
Teena Hughes Pediatrics- Site Number : 8400042
Tampa, Florida, United States
Morehouse School of Medicine - Atlanta- Site Number : 8400037
Atlanta, Georgia, United States
Emory-Children's Center- Site Number : 8400001
Atlanta, Georgia, United States
Agile Clinical Research Trials- Site Number : 8400015
Atlanta, Georgia, United States
Tekton Research, LLC - 4961 Buford Hwy - Georgia - PPDS- Site Number : 8400064
Chamblee, Georgia, United States
Velocity Clinical Research - (Macon - Georgia) - PPDS- Site Number : 8400041
Macon, Georgia, United States
iResearch Savannah - CenExel - PPDS- Site Number : 8400032
Savannah, Georgia, United States
Medical Research Partners - Ammon- Site Number : 8400059
Ammon, Idaho, United States
Clinical Research Prime- Site Number : 8400013
Idaho Falls, Idaho, United States
Leavitt Women's Healthcare- Site Number : 8400033
Idaho Falls, Idaho, United States
Snake River Research- Site Number : 8400046
Idaho Falls, Idaho, United States
Michigan Institute of Research- Site Number : 8400055
Allen Park, Michigan, United States
Vida Clinical Studies - Dearborn Heights- Site Number : 8400072
Dearborn Heights, Michigan, United States
Great Lakes Research Institute- Site Number : 8400060
Southfield, Michigan, United States
Clinical Research Institute - Minneapolis- Site Number : 8400011
Minneapolis, Minnesota, United States
Boeson Research - Great Falls- Site Number : 8400008
Great Falls, Montana, United States
Velocity Clinical Research - Hastings- Site Number : 8400017
Hastings, Nebraska, United States
Be Well Clinical Studies - Lincoln- Site Number : 8400058
Lincoln, Nebraska, United States
Velocity Clinical Research (Norfolk - Nebraska) - PPDS- Site Number : 8400038
Norfolk, Nebraska, United States
Quality Clinical Research - Omaha - Regency Circle- Site Number : 8400016
Omaha, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400054
Omaha, Nebraska, United States
Prime Global Research, Inc.- Site Number : 8400043
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400063
Cincinnati, Ohio, United States
Senders Pediatrics- Site Number : 8400006
South Euclid, Ohio, United States
Cyn3rgy Research- Site Number : 8400014
Gresham, Oregon, United States
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400036
Charleston, South Carolina, United States
Palmetto Pediatrics- Site Number : 8400012
North Charleston, South Carolina, United States
Parkside Pediatrics - Simpsonville- Site Number : 8400071
Simpsonville, South Carolina, United States
Clinical Research Associates Inc- Site Number : 8400005
Nashville, Tennessee, United States
Tekton Research, LLC - Beaumont - PPDS- Site Number : 8400061
Beaumont, Texas, United States
South Texas Urgent Care - Del Rio- Site Number : 8400062
Del Rio, Texas, United States
Ventavia Research Group - Fort Worth- Site Number : 8400022
Fort Worth, Texas, United States
Private Practice - Dr. Chinyere N. Awa- Site Number : 8400066
Houston, Texas, United States
DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400044
Houston, Texas, United States
Maximos Ob/Gyn- Site Number : 8400023
League City, Texas, United States
Pediatric Center - Richmond- Site Number : 8400019
Richmond, Texas, United States
Tekton Research - FM78- Site Number : 8400067
San Antonio, Texas, United States
Alliance for Multispecialty Research - Layton - North Robins Drive- Site Number : 8400030
Layton, Utah, United States
Wee Care Pediatrics - Roy- Site Number : 8400002
Roy, Utah, United States
Wee Care Pediatrics - Syracuse- Site Number : 8400004
Syracuse, Utah, United States
Investigational Site Number : 0320006
Buenos Aires, Buenos Aires F.D., Argentina
Investigational Site Number : 0320007
Buenos Aires, Buenos Aires F.D., Argentina
Investigational Site Number : 0320003
Río Cuarto, Córdoba Province, Argentina
Investigational Site Number : 0320005
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320004
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320002
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Associação Obras Sociais Irmã Dulce - Centro de Pesquisa ClÃ-nica (CPEC)- Site Number : 0760009
Salvador, Estado de Bahia, Brazil
Freire Pesquisa Clínica- Site Number : 0760001
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles- Site Number : 0760007
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS- Site Number : 0760010
Ribeirão Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760006
São José do Rio Preto, São Paulo, Brazil
Hospital São Paulo da Universidade Federal de Sao Paulo - Escola Paulista de Medicina UNIFESP-EPM- Site Number : 0760002
SãO Paulo, São Paulo, Brazil
Centro Paulista de Investigaçăo Clínica - CEPIC- Site Number : 0760004
São Paulo, , Brazil
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Port Montt, , Chile
Investigational Site Number : 1560009
Jiangsu, , China
Investigational Site Number : 1700004
Acacías, , Colombia
Investigational Site Number : 1700002
Chía, , Colombia
Investigational Site Number : 1700003
Girardot, , Colombia
Investigational Site Number : 2460003
Espoo, , Finland
Investigational Site Number : 2460005
Helsinki, , Finland
Investigational Site Number : 2460008
Järvenpää, , Finland
Investigational Site Number : 2460004
Kokkola, , Finland
Investigational Site Number : 2460002
Oulu, , Finland
Investigational Site Number : 2460006
Seinäjoki, , Finland
Investigational Site Number : 2460009
Tampere, , Finland
Investigational Site Number : 2460001
Turku, , Finland
Investigational Site Number : 3920011
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920007
Kawagoe, Saitama, Japan
Investigational Site Number : 3920010
Shizuoka-Shi Aoi-Ku, Shizuoka, Japan
Investigational Site Number : 3920006
Edogawa-Ku, Tokyo, Japan
Investigational Site Number : 3920001
Fukui, , Japan
Investigational Site Number : 3920002
Fukui-shi, , Japan
Investigational Site Number : 3920004
Fukuoka, , Japan
Investigational Site Number : 3920003
Kagoshima, , Japan
Investigational Site Number : 3920005
Kasuga-Shi, , Japan
Investigational Site Number : 3920008
Lizuka-shi, , Japan
Investigational Site Number : 3920009
Osaka, , Japan
Investigational Site Number : 4040007
Butere, , Kenya
Investigational Site Number : 4040001
Kericho, , Kenya
Investigational Site Number : 4040002
Kisumu, , Kenya
Investigational Site Number : 4040003
Kisumu, , Kenya
Investigational Site Number : 4040006
Nairobi, , Kenya
Investigational Site Number : 4840007
Mexico City, , Mexico
Investigational Site Number : 4840008
Monterrey, , Mexico
Investigational Site Number : 4840004
Veracruz, , Mexico
Investigational Site Number : 5240003
Dhulikhel N.p, Bagmati, Nepal
Investigational Site Number : 5240001
Kathmandu, Bagmati, Nepal
Investigational Site Number : 5240002
Nepalgunj, Bheri, Nepal
Clinical Research Investigator Group- Site Number : 6300001
Bayamón, , Puerto Rico
Clinical Research Puerto Rico (CRPR), Inc. - Guayama- Site Number : 6300005
Guayama, , Puerto Rico
Caribbean Medical Research Center- Site Number : 6300003
San Juan, , Puerto Rico
Hospital Pediatrico Universitario- Site Number : 6300002
San Juan, , Puerto Rico
Investigational Site Number : 7100007
Brits, , South Africa
Investigational Site Number : 7100008
City of Cape Town, , South Africa
Investigational Site Number : 7100001
East London, , South Africa
Investigational Site Number : 7100005
Johannesburg, , South Africa
Investigational Site Number : 7100004
Johannesburg, , South Africa
Investigational Site Number : 7100003
Johannesburg, , South Africa
Investigational Site Number : 7100006
Paarl, , South Africa
Investigational Site Number : 7100002
Pretoria, , South Africa
Investigational Site Number : 7100009
Soshanguve, , South Africa
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003
Móstoles, Madrid, Spain
Investigational Site Number : 7240005
Pamplona, Navarre, Spain
Investigational Site Number : 7240002
Seville, Sevilla, Spain
Investigational Site Number : 7240004
Santiago de Compostela, , Spain
Investigational Site Number : 7640002
Bangkok, , Thailand
Investigational Site Number : 7640005
Bangkok, , Thailand
Investigational Site Number : 7640004
Bangkok, , Thailand
Investigational Site Number : 7640001
Chiang Mai, , Thailand
Investigational Site Number : 7640006
Hat Yai, , Thailand
Investigational Site Number : 7640003
Khon Kaen, , Thailand
Investigational Site Number : 8260003
Hayle, Cornwall, United Kingdom
Investigational Site Number : 8260005
Exeter, Devon, United Kingdom
Investigational Site Number : 8260007
Southampton, Hampshire, United Kingdom
Investigational Site Number : 8260004
Bristol, , United Kingdom
Countries
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Other Identifiers
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VAD00004
Identifier Type: -
Identifier Source: org_study_id
2023-505762-29
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1280-7192
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAD00004
Identifier Type: OTHER
Identifier Source: secondary_id
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