Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
NCT ID: NCT04491877
Last Updated: 2025-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
259 participants
INTERVENTIONAL
2020-09-17
2023-04-13
Brief Summary
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* To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus.
* To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants.
The secondary objectives of the study were:
* To quantify the amount of vaccine virus shed by each participant by baseline serostatus.
* To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus.
* To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants.
* To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus.
* To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Cohort 1 (RSV vaccine formulation 1)
1 administration of RSV vaccine formulation 1 on Day 0
RSV vaccine formulation 1
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Cohort 1 (Placebo)
1 administration of placebo on Day 0
Placebo
Pharmaceutical form: Suspension Route of administration: Intranasal
Cohort 2 (RSV vaccine formulation 1)
2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
RSV vaccine formulation 1
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Cohort 2 (Placebo)
2 administrations of placebo on Day 0 and Day 56
Placebo
Pharmaceutical form: Suspension Route of administration: Intranasal
Cohort 3 (RSV vaccine formulation 2)
1 administration of RSV vaccine formulation 2 on Day 0
RSV vaccine formulation 2
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Cohort 3 (Placebo)
1 administration of placebo on Day 0
Placebo
Pharmaceutical form: Suspension Route of administration: Intranasal
Cohort 4 (RSV vaccine formulation 1)
2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56
RSV vaccine formulation 1
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Cohort 4 (RSV vaccine formulation 2)
2 administrations of RSV vaccine formulation 2 on Day 0 and Day 56
RSV vaccine formulation 2
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Cohort 4 (Placebo)
2 administrations of placebo on Day 0 and Day 56
Placebo
Pharmaceutical form: Suspension Route of administration: Intranasal
Interventions
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RSV vaccine formulation 1
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
RSV vaccine formulation 2
Pharmaceutical form: Suspension of virus Route of administration: Intranasal
Placebo
Pharmaceutical form: Suspension Route of administration: Intranasal
Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness if required by local regulations).
* Participant and parent / guardian / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria
* Born at less than 37 weeks gestation and less than 1 year of age at the time
* 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).
* Probable or confirmed case of Coronavirus Disease 2019 (COVID-19).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
* Any chronic illness
• Chronic illness may include, but is not limited to, cardiac disorders, lung disease (including any history of reactive airway disease, receipt of bronchodilator therapy, or medically diagnosed wheezing), renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases
* Any history of medically diagnosed wheezing
* Any acute febrile, respiratory or gastrointestinal illness in the past 24 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
* Any previous anaphylactic reaction
* Current suspected or documented developmental disorder, delay, or other developmental problem
* Receipt of any of the following vaccines prior to enrollment:
* any influenza vaccine within 7 days prior, or
* any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
* any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
* another investigational vaccine or investigational drug within 28 days prior
* Previous receipt of a licensed or investigational RSV vaccine or previous receipt or planned administration of any anti-RSV product (such as ribavirin or RSV immune immune globulins \[IG\] or RSV monoclonal antibody)
* Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment
* Receipt of any of the following medications within 3 days prior to study enrollment (Day 0):
* systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
* intranasal medications, or
* other prescription medication except as permitted concomitant medications (prescription or non-prescription) including nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents
* Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days prior to enrollment (Day 0)
* Any previous vaccine-associated adverse reaction that was Grade 3 or above. Note: if grading is not possible, determine if the reaction was considered severe or life threatening; if so, it is exclusionary.
* Scheduled administration of the following after planned inoculation:
* any influenza vaccine within 7 days after, or
* inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
* any live vaccine other than rotavirus in the 28 days after, or
* another investigational vaccine or investigational drug in the 56 days after.
* Any previous receipt of supplemental oxygen therapy in a home or hospital setting, except the temporary receipt of supplemental oxygen for transient tachypnea in newborn
* 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 enrollment
* a person receiving immunosuppressant agents
* a person living with a solid organ or bone marrow transplant
* Participation at the time of study enrollment (or in the 6 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Member of a household that contains, or will contain, an infant who is less than 6 months of age at the enrollment date (or in the 6 weeks preceding the first trial vaccination) through Day 28
* Member of a household that contains another child/other children who is/are, or is/are scheduled to be, enrolled in this study in the same year AND the date of enrollment will not be concurrent with the other participant(s) living in the household (i.e., all eligible children from the same household must be enrolled on the same date)
* Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days following inoculation
* Deprived of freedom in an emergency setting or hospitalized involuntarily
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
6 Months
18 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Matrix Clinical Research-Site Number:8400012
Gardena, California, United States
Paradigm Clinical Research-Site Number:8400026
La Mesa, California, United States
Matrix Clinical Research-Site Number:8400032
Los Angeles, California, United States
California Research Foundation-Site Number:8400016
San Diego, California, United States
Elite Clinical Trials, Inc.-Site Number:8400001
Blackfoot, Idaho, United States
Leavitt Clinical Research-Site Number:8400036
Idaho Falls, Idaho, United States
Snake River Research-Site Number:8400022
Idaho Falls, Idaho, United States
The South Bend Clinic Center for Research-Site Number:8400024
South Bend, Indiana, United States
Alliance for Multispeciality Research-Site Number:8400014
El Dorado, Kansas, United States
AMR - Newton-Site Number:8400002
Newton, Kansas, United States
Michael W. Simon, MD, PSC-Site Number:8400013
Lexington, Kentucky, United States
Benchmark Research-Site Number:8400006
Covington, Louisiana, United States
Nola Research Works-Site Number:8400017
New Orleans, Louisiana, United States
Clinical Research Institute-Site Number:8400053
Minneapolis, Minnesota, United States
Boeson Research-Site Number:8400011
Missoula, Montana, United States
Be Well Clinical Studies-Site Number:8400054
Lincoln, Nebraska, United States
Meridian Clinical Research - Norfolk-Site Number:8400005
Norfolk, Nebraska, United States
MedPharmics Inc-Site Number:8400040
Albuquerque, New Mexico, United States
East Carolina University/Brody Medical Sciences Building-Site Number:8400043
Greenville, North Carolina, United States
Coastal Pediatric Research-Site Number:8400031
Charleston, South Carolina, United States
Tribe Clinical Research-Site Number:8400027
Greenville, South Carolina, United States
FMC Science-Site Number:8400042
Lampasas, Texas, United States
JBR Clinical Research-Site Number:8400041
Salt Lake City, Utah, United States
Pediatric Associates of Charlottesville North-Site Number:8400007
Charlottesville, Virginia, United States
National Clinical Research Inc-Site Number:8400004
Richmond, Virginia, United States
Investigational Site Number :1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number :1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number :3400001
San Pedro Sula, , Honduras
Investigational Site Number :3400002
Tegucigalpa, , Honduras
Countries
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References
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Idoko OT, Vargas SL, Bueso A, Rivera D, Edward H, Simon M, Banooni P, Berger S, Janicot S, Vercasson C, Pallardy S, Nteene R, Adhikarla H, Gerchman E, Gasparotto M, Gallichan S, Rivas E, Buchholz UJ, Collins PL, Sesay S, Gurunathan S, De Bruijn I, Dhingra MS. Live-Attenuated Intranasal RSV Vaccine in Infants and Toddlers. NEJM Evid. 2025 Sep;4(9):EVIDoa2500026. doi: 10.1056/EVIDoa2500026. Epub 2025 Aug 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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VAD00001 Plain Language Results Summary
Other Identifiers
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U1111-1238-1869
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAD00001
Identifier Type: -
Identifier Source: org_study_id
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