Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
NCT ID: NCT06397768
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
2226 participants
INTERVENTIONAL
2024-05-13
2025-09-30
Brief Summary
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Detailed Description
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* Cohort 1: Visits at 6, 7, and 8 and 9 months of age for both groups with visit at 10 months of age for Group 2 only
* Cohort 2: Visits at 12, 13, 14 and 15 months of age for both groups with visit at 16 months of age for Group 4 only
* Routine pediatric vaccines (authorized auxiliary medicinal products (AxMP) will be administered at 6 months in Cohort 1 and 12 months of age in Cohort 2, as per Advisory Committee on Immunization Practice (ACIP) or local country recommendations.
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, investigators or Sponsor study staff
Study Groups
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Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months)
Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 6 months. Vaccines administered at age 6 months: RSVt Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered non-concomitantly at 7 months of age
RSVt vaccine
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Hepatitis B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Streptococcus pneumoniae vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Rotavirus vaccine
Pharmaceutical form:Oral solution-Route of administration:Oral
Placebo
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months)
Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 7 months. Vaccines administered at age 6 months: Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered concomitantly at 6 months of age
RSVt vaccine
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Hepatitis B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Streptococcus pneumoniae vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Rotavirus vaccine
Pharmaceutical form:Oral solution-Route of administration:Oral
Placebo
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months)
Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 12 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered non-concomitantly at 13 months of age
RSVt vaccine
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Streptococcus pneumoniae vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Measles, mumps, and rubella vaccine
Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular
Varicella virus vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular
Placebo
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months)
Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 13 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered concomitantly at 12 months of age
RSVt vaccine
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Streptococcus pneumoniae vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Measles, mumps, and rubella vaccine
Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular
Varicella virus vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular
Placebo
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Interventions
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RSVt vaccine
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Hepatitis B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Streptococcus pneumoniae vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Rotavirus vaccine
Pharmaceutical form:Oral solution-Route of administration:Oral
Measles, mumps, and rubella vaccine
Pharmaceutical form:Lyophilized live virus for reconstitution -Route of administration:Subcutaneous or Intramuscular
Varicella virus vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Subcutaneous or Intramuscular
Placebo
Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who are healthy as determined by medical evaluation including medical history and physical examination
* For Cohort 1: Infant received doses of vaccines containing hepatitis B, diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), and inactivated poliovirus vaccine (IPV) antigens, with Advisory Committee on Immunization Practice (ACIP) recommended vaccines. The last dose(s) of these vaccines must be at least 28 days before the first study visit
* Infant received the recommended doses of a recommended pneumococcal conjugate vaccine (as per local schedule) at least 28 days before the first study visit.
Exclusion Criteria
* Known previous infection with diphtheria, tetanus, Hib, measles, mumps, rubella, rotavirus, pneumococcus, polio, hepatitis B virus
* 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 living with human immunodeficiency virus (HIV)
* 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
* History of definitive contraindications to any of the concomitant vaccines that will be administered as part of the study protocol
* Participant's biological mother with previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding
* Receipt of any vaccine in the 4 weeks preceding RSVt vaccine administration or planned receipt of any vaccine outside of study protocol in the 4 weeks following RSVt vaccine administration, except for influenza and/or COVID-19 vaccination, which may be received at least 1 week before or 1 week after RSVt vaccine administration
* 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
* 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
* Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration or planned receipt for duration of the study
* For Cohort 1: Prior receipt of routine 6-month pediatric vaccine doses (as per local schedule)
* For Cohort 2: Prior receipt of routine 12-month pediatric vaccine doses (as per local schedule)
* Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
6 Months
12 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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Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400007
Birmingham, Alabama, United States
South Alabama Medical Clinic- Site Number : 8400065
Grand Bay, Alabama, United States
MedPharmics - Mobile - Dauphin Street- Site Number : 8400017
Mobile, Alabama, United States
Northwest Arkansas Pediatric Clinic- Site Number : 8400002
Fayetteville, Arkansas, United States
Alliance Research Institute- Site Number : 8400040
Bell Gardens, California, United States
Matrix Clinical Research - Huntington Park- Site Number : 8400018
Huntington Park, California, United States
Paradigm Clinical Research Centers- Site Number : 8400059
La Mesa, California, United States
Matrix Clinical Research - Los Angeles- Site Number : 8400008
Los Angeles, California, United States
Kaiser Permanente - Oakland Medical Center- Site Number : 8400047
Oakland, California, United States
Kaiser Permanente - Sierra Gardens- Site Number : 8400063
Roseville, California, United States
Kaiser Permanente - Point West Medical Offices- Site Number : 8400064
Sacramento, California, United States
Kaiser Permanente - San Jose Medical Center- Site Number : 8400060
San Jose, California, United States
Kaiser Permanente - Santa Clara- Site Number : 8400061
Santa Clara, California, United States
Integrated Clinical Research- Site Number : 8400036
Tarzana, California, United States
Kaiser Permanente - Walnut Creek Medical Center- Site Number : 8400062
Walnut Creek, California, United States
Velocity Clinical Research - Washington DC- Site Number : 8400050
Washington D.C., District of Columbia, United States
The Medici Medical Research- Site Number : 8400055
Hollywood, Florida, United States
Dade Research Center- Site Number : 8400014
Miami, Florida, United States
Riveldi Biomedical Research and Associates - Miami- Site Number : 8400015
Miami, Florida, United States
SEC Clinical Research- Site Number : 8400034
Pensacola, Florida, United States
PAS Research- Site Number : 8400005
Tampa, Florida, United States
Leavitt Women's Healthcare- Site Number : 8400009
Idaho Falls, Idaho, United States
Velocity Clinical Research - Sioux City- Site Number : 8400054
Sioux City, Iowa, United States
Alliance for Multispeciality Research - El Dorado- Site Number : 8400019
El Dorado, Kansas, United States
University of Kentucky Chandler Medical Center- Site Number : 8400051
Lexington, Kentucky, United States
Velocity Clinical Researchâ€" New Orleans- Site Number : 8400058
New Orleans, Louisiana, United States
NOLA Research Works- Site Number : 8400044
New Orleans, Louisiana, United States
MedPharmics - Biloxi- Site Number : 8400011
Biloxi, Mississippi, United States
QPS Bio-Kinetic Clinical Applications- Site Number : 8400046
Springfield, Missouri, United States
Boeson Research - Great Falls- Site Number : 8400041
Great Falls, Montana, United States
Boeson Research - Missoula- Site Number : 8400006
Missoula, Montana, United States
Velocity Clinical Research - Hastings- Site Number : 8400016
Hastings, Nebraska, United States
Midwest Childrens Health Research Institute- Site Number : 8400038
Lincoln, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400001
Omaha, Nebraska, United States
PAS Research- Site Number : 8400049
Henderson, Nevada, United States
Summerwood Pediatrics- Site Number : 8400021
Liverpool, New York, United States
SUNY Upstate Medical University - Syracuse- Site Number : 8400029
Syracuse, New York, United States
Dayton Clinical Research- Site Number : 8400030
Dayton, Ohio, United States
Ohio Pediatrics - Dayton- Site Number : 8400033
Dayton, Ohio, United States
Senders Pediatrics- Site Number : 8400022
South Euclid, Ohio, United States
Cyn3rgy Research- Site Number : 8400053
Gresham, Oregon, United States
Square-1 Clinical Research- Site Number : 8400031
Erie, Pennsylvania, United States
Pas Research - Pittsburgh- Site Number : 8400043
Pittsburgh, Pennsylvania, United States
Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8400012
Greenville, South Carolina, United States
South Texas Clinical Research- Site Number : 8400004
Corpus Christi, Texas, United States
Javara - Privia Medical Group North Texas - Dallas- Site Number : 8400003
Dallas, Texas, United States
PAS RESEARCH- Site Number : 8400035
Edinburg, Texas, United States
Ventavia Research Group - Fort Worth- Site Number : 8400020
Fort Worth, Texas, United States
Ventavia Research Group - Houston - North Loop West- Site Number : 8400010
Houston, Texas, United States
UTHealth Houston- Site Number : 8400037
Houston, Texas, United States
DM Clinical Research - Houston - Jones Road- Site Number : 8400052
Houston, Texas, United States
Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400045
Houston, Texas, United States
Chemidox Clinical Trials- Site Number : 8400039
Houston, Texas, United States
Houston Clinical Research Associates- Site Number : 8400013
Houston, Texas, United States
University of Texas Medical Branch at Galveston- Site Number : 8400057
League City, Texas, United States
Maximos Ob/Gyn- Site Number : 8400024
League City, Texas, United States
Research Your Health- Site Number : 8400066
Plano, Texas, United States
Pediatric Center - Richmond- Site Number : 8400032
Richmond, Texas, United States
North Houston Internal Medicine and Pediatric Center- Site Number : 8400025
Tomball, Texas, United States
Utah Valley Pediatrics - Orem- Site Number : 8400067
Orem, Utah, United States
Ogden Clinic - Mountain View - CCT Research- Site Number : 8400056
Pleasant View, Utah, United States
Investigational Site Number : 4840001
Mexico City, Mexico City, Mexico
Investigational Site Number : 4840002
Temixco, Morelos, Mexico
Investigational Site Number : 4840004
Mexico City, , Mexico
Investigational Site Number : 6300001
Caguas, , Puerto Rico
Investigational Site Number : 6300003
Ponce, , Puerto Rico
Investigational Site Number : 6300004
Trujillo Alto, , Puerto Rico
Countries
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Other Identifiers
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VAD00016
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1290-7356
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-000262-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VAD00016
Identifier Type: -
Identifier Source: org_study_id
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