Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Launched by SANOFI PASTEUR, A SANOFI COMPANY · Feb 7, 2024
Trial Information
Current as of June 19, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new vaccine for Respiratory Syncytial Virus (RSV) in infants and toddlers aged 6 months to less than 22 months. RSV is a common virus that can cause serious respiratory infections in young children. The study will compare the new RSV vaccine, given as a nasal spray, to a placebo (a substance with no active ingredients) to see how well it works and how safe it is. About 6,300 children will take part in this study, which will last for 24 months for each participant.
To be eligible for the study, children must be healthy and born at full term. However, some children may not be able to join the study if they have certain health conditions, such as a weakened immune system or a recent serious illness. Participants will receive two doses of either the vaccine or the placebo, and researchers will closely monitor their health throughout the study to ensure safety. If you have a child who meets these criteria and you’re interested in learning more, this study could help advance RSV prevention in young children.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria: -Aged 6 months to \< 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)
- • Participants who are healthy as determined by medical evaluation including medical history
- • Born at full term of pregnancy (≥ 37 weeks)
- Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
- • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- • 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.
About Sanofi Pasteur, A Sanofi Company
Sanofi Pasteur, a subsidiary of Sanofi, is a global leader in the development and production of vaccines. With a rich heritage in vaccine innovation, the company is dedicated to advancing public health by providing safe, effective, and accessible immunizations for a wide range of infectious diseases. Sanofi Pasteur invests significantly in research and development to address evolving health challenges and to enhance vaccine coverage worldwide. Committed to collaboration with health organizations and communities, the company strives to protect individuals and populations through its comprehensive portfolio of vaccines, contributing to the prevention of diseases and the promotion of healthier lives globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Idaho Falls, Idaho, United States
Veracruz, , Mexico
Pamplona, Navarra, Spain
San Pedro Sula, , Honduras
Kokkola, , Finland
League City, Texas, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
San Miguel De Tucumán, Tucumán, Argentina
San Miguel De Tucumán, Tucumán, Argentina
San Pedro Sula, , Honduras
Tegucugalpa, , Honduras
Cali, , Colombia
Birmingham, Alabama, United States
Guntersville, Alabama, United States
Tucson, Arizona, United States
Madera, California, United States
San Diego, California, United States
Tarzana, California, United States
Victorville, California, United States
Coconut Creek, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chamblee, Georgia, United States
Macon, Georgia, United States
Savannah, Georgia, United States
Stockbridge, Georgia, United States
Ammon, Idaho, United States
Idaho Falls, Idaho, United States
Idaho Falls, Idaho, United States
Idaho Falls, Idaho, United States
Allen Park, Michigan, United States
Dearborn Heights, Michigan, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Great Falls, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Hastings, Nebraska, United States
Lincoln, Nebraska, United States
Norfolk, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Bronx, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Gresham, Oregon, United States
Charleston, South Carolina, United States
North Charleston, South Carolina, United States
Simpsonville, South Carolina, United States
Nashville, Tennessee, United States
Beaumont, Texas, United States
Dallas, Texas, United States
Del Rio, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Richmond, Texas, United States
San Antonio, Texas, United States
Layton, Utah, United States
Roy, Utah, United States
Syracuse, Utah, United States
Charlottesville, Virginia, United States
Ciudad Autónoma De Buenos Aires, Ciudad De Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Ciudad De Buenos Aires, Argentina
Río Cuarto, Córdoba, Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Acacías, , Colombia
Aguazul, , Colombia
Armenia, , Colombia
Barranquilla, , Colombia
Bogotá, , Colombia
Chía, , Colombia
Girardot, , Colombia
Helsinki, , Finland
Seinäjoki, , Finland
Tampere, , Finland
Sapporo Shi Nishi Ku, Hokkaido, Japan
Shizuoka Shi Aoi Ku, Shizuoka, Japan
Iizuka Shi, , Japan
Osaka Shi, , Japan
La Joya, , Mexico
Monterrey, , Mexico
Bayamon, , Puerto Rico
Guayama, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Barcelona, Barcelona [Barcelona], Spain
Mostoles, Madrid, Spain
Santiago De Compostela, , Spain
Sevilla, , Spain
Bangkok Noi, , Thailand
Mueang Chiang Mai, , Thailand
Mueang Khon Kaen, , Thailand
Ratchathewi, , Thailand
Ratchathewi, , Thailand
Songkla, , Thailand
Hayle, Cornwall, United Kingdom
Exeter, Devon, United Kingdom
Runcorn, Halton, United Kingdom
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Tarzana, California, United States
Doral, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Houston, Texas, United States
Salvador, Bahia, Brazil
Ribeirão Preto, São Paulo, Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Independencia, Reg Metropolitana De Santiago, Chile
Bogota, , Colombia
Medellin, , Colombia
Espoo, , Finland
Järvenpää, , Finland
Oulu, , Finland
Turku, , Finland
Dhulikhel N.P, Bagmati, Nepal
Kathmandu, Bagmati, Nepal
Nepalgunj, Bheri, Nepal
Bristol, , United Kingdom
Victorville, California, United States
Aurora, Colorado, United States
Coconut Creek, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Rexburg, Idaho, United States
Moline, Illinois, United States
Baltimore, Maryland, United States
Minneapolis, Minnesota, United States
Norfolk, Nebraska, United States
Reno, Nevada, United States
Bronx, New York, United States
Gresham, Oregon, United States
Houston, Texas, United States
Roy, Utah, United States
Fukui Shi, , Japan
Kisumu, , Kenya
Kisumu, , Kenya
Belo Horizonte, Minas Gerais, Brazil
São José Do Rio Preto, São Paulo, Brazil
Jiangsu, , China
Kawagoe Shi, Saitama, Japan
Fukuoka Shi Higashi Ku, , Japan
Kasuga Shi, , Japan
Buffalo City, , South Africa
City Of Cape Town, , South Africa
City Of Johannesburg, , South Africa
City Of Tshwane, , South Africa
Johannesburg, , South Africa
Madibeng, , South Africa
Paarl, , South Africa
Soshanguve, , South Africa
Seville, Sevilla, Spain
São José Do Rio Preto, São Paulo, Brazil
São Paulo, , Brazil
Birmingham, Alabama, United States
Guntersville, Alabama, United States
Tucson, Arizona, United States
Madera, California, United States
Tarzana, California, United States
Victorville, California, United States
Coconut Creek, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chamblee, Georgia, United States
Macon, Georgia, United States
Savannah, Georgia, United States
Ammon, Idaho, United States
Idaho Falls, Idaho, United States
Idaho Falls, Idaho, United States
Idaho Falls, Idaho, United States
Allen Park, Michigan, United States
Dearborn Heights, Michigan, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Great Falls, Montana, United States
Hastings, Nebraska, United States
Lincoln, Nebraska, United States
Norfolk, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Bronx, New York, United States
Cincinnati, Ohio, United States
South Euclid, Ohio, United States
Gresham, Oregon, United States
Charleston, South Carolina, United States
North Charleston, South Carolina, United States
Simpsonville, South Carolina, United States
Nashville, Tennessee, United States
Beaumont, Texas, United States
Del Rio, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
League City, Texas, United States
Richmond, Texas, United States
San Antonio, Texas, United States
Layton, Utah, United States
Roy, Utah, United States
Syracuse, Utah, United States
Buenos Aires, Ciudad De Buenos Aires, Argentina
Buenos Aires, , Argentina
Salvador, Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Ribeirão Preto, São Paulo, Brazil
São Paulo, , Brazil
Sapporo, Hokkaido, Japan
Kagoshima Shi, Kagoshima, Japan
Kawagoe, Saitama, Japan
Edogawa Ku, Tokyo, Japan
Fukui Shi, , Japan
Fukui, , Japan
Fukuoka, , Japan
Osaka, , Japan
Butere, , Kenya
Kericho, , Kenya
Nairobi, , Kenya
Bayamon, , Puerto Rico
Guayama, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Brits, , South Africa
Johannesburg, , South Africa
Johannesburg, , South Africa
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Hat Yai, , Thailand
Khon Kaen, , Thailand
Tarzana, California, United States
Victorville, California, United States
Orlando, Florida, United States
Allen Park, Michigan, United States
Simpsonville, South Carolina, United States
Houston, Texas, United States
San Antonio, Texas, United States
Layton, Utah, United States
Salvador, Bahia, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sã£O Paulo, São Paulo, Brazil
Puerto Montt, , Chile
Kagoshima, , Japan
Lizuka Shi, , Japan
Mexico City, , Mexico
East London, , South Africa
Pretoria, , South Africa
Southampton, Hampshire, United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported