Respiratory Syncytial Virus InfectionPhase 1/2NCT05687279
Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
A Phase 1/2 study testing RSVt Vaccine in people with Respiratory Syncytial Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 6 sites in 2 countries.
Trial summary
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- RSVt Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 6 Feb 2023to 27 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6 months to < 24 months on the day of inclusion (from the day of the 6 months after birth to the day before the 2nd birthday)
- Participants who are healthy as determined by medical evaluation including medical history.
- Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
- Attends a daycare facility at least 3 days per week and 4 hours per day at which the participant would be in a contact group/playroom of at least one other child 6 to < 24 months of age who will participate in this study or is a member of a household, which includes at least one other child 6 to < 24 months of age who will participate in this study
Who cannot join
- 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
- 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 COVID-19 at the time of enrollment
- Member of a household that contains an immunocompromised individual, including, but not limited to:
Show all 25Show fewer
- 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
- Member of a household that includes, or will include, an infant who is less than 6 months of age at the time of enrollment
- Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/legally acceptable representative is unable or unwilling to suspend attendance at the daycare facility for 28 days following study intervention administration
- Any need of supplemental oxygen therapy in a home or hospital setting at the time of enrollment.
- Participant's mother previous receipt or planned administration of an investigational RSV vaccine or any monoclonal antibody (such as Infliximab) during pregnancy and/or breastfeeding.
- Receipt or planned receipt of any of the following vaccines prior to or after the first study intervention administration:
- any influenza vaccine within 7 days prior to and after, or any COVID-19 or inactivated vaccine or live-attenuated rotavirus vaccine within 14 days prior to and after, or
- any live vaccine, other than rotavirus vaccine, within 28 days prior to and after
- Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV Immunoglobulin (IG) or RSV monoclonal antibody) 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
- Receipt at the time of enrollment or previous receipt of salicylate (aspirin) or salicylate-containing products
- 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
- 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 is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Puerto Rico4 sites
Investigational Site Number : 6300004
Bayamón, 00960
Investigational Site Number : 6300002
Carolina, 984
Investigational Site Number : 6300003
Guayama, 00784
Investigational Site Number : 6300001
San Juan, 00918
United States2 sites
Meridian Clinical Research Norfolk Site Number : 8400003
Norfolk, Nebraska, 68701
Velocity Clinical Research, Omaha Site Number : 8400001
Omaha, Nebraska, 68134
About this study
Official title: Phase II, Randomized, Observer-blind, Placebo-controlled, Multi-center Study of a Live Attenuated Respiratory Syncytial Virus Vaccine to Assess the Vaccine Virus' Transmissibility in Household or Daycare Center Settings, Shedding, and Genetic Stability, and to Describe the Immunogenicity and Safety of the Vaccine in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age.
Read the detailed description
The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each).
- Conditions
- Respiratory Syncytial Virus Infection
- Being tested
- RSVt Vaccine, Control Group
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVt VaccineBiological
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal
Control GroupOther
Pharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal
| Study group | Role | What they receive |
|---|---|---|
| RSVt Vaccine Group | Experimental | 2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57 Receives: Biological: RSVt Vaccine |
| Control Group | Placebo comparator | 2 intranasal administrations (56 days apart) of the placebo at D01 and D57 Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Placebo Receiving Pediatric Participants With Vaccine Virus Detected in Nasal Swabs After the First Vaccination
Nasal swabs were collected to assess the presence of vaccine virus after first vaccination. Vaccine virus transmission was defined as presence of detected vaccine virus confirmed by RSVt quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay (vaccine virus shedding >=lower limit of detection [LOD=2.80 log10 copies/mL]) in pediatric participants receiving placebo. Percentages are rounded off to the tenth decimal place.
Measured: Pre-vaccination on Day 1 and post-vaccination on Days 4, 8, 11, 15, 18 and 22
Titer of Vaccine Virus Shedding in All Pediatric Participants Detected in Nasal Swabs
Nasal swabs were collected to assess the shedding of the attenuated RSV vaccine strain and quantified by RSVt qRT PCR assay. Quantified virus shedding was defined as vaccine virus shedding >=lower limit of quantification (LLOQ=3.37 log10 copies/mL).
Measured: Pre-vaccination on Day 1 and post-vaccination on Days 4, 8, 11, 15, 18, 22, 64 and 71
Percentage of Placebo Receiving Pediatric Participants With Detected Shedding Who Showed Any Genetic Sequence Variation After Each Vaccination
Nasal swabs were collected to identify the difference in genetic sequence of mutated vaccine virus segments compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo after each vaccination. Detected virus shedding was defined as vaccine virus shedding >=LOD (2.80 log10 copies/mL).
Measured: Up to 21 days after each vaccination (Day 1 to Day 22 and Day 57 to Day 78)
Secondary outcomes (5)
Geometric Mean Titers (GMTs) of RSV A Serum Neutralizing Antibody (nAb) Titers
Serum samples were collected at specified timepoints for immunogenicity assessments. RSV A serum neutralizing antibody titers were evaluated by microneutralization (MN) assay.
Measured: Pre-vaccination on Day 1 (first vaccination) and Day 57 (second vaccination) and up to 28 days after second vaccination, Day 85
Secondary: Geometric Mean Titers of RSV Serum Anti-F Immunoglobulin G (IgG) Enzyme-linked Immuno-adsorbant Assay (ELISA) Antibody
Serum samples were collected at specified timepoints for immunogenicity assessments. Antibodies to RSV F antigen were measured using the anti RSV F IgG ELISA method.
Measured: Pre-vaccination on Day 1 (first vaccination) and Day 57 (second vaccination) and up to 28 days after second vaccination, Day 85
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after each vaccination and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs.
Measured: Up to 30 minutes after each vaccination (Days 1 and 57)
Number of Participants With Solicited Administration Site Reactions and Systemic Reactions
A solicited reaction was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered. An administration site reaction was an AR at and around the administration/injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the vaccine even if there was evidence of alternative etiology.
Measured: Up to 21 days after each vaccination (Day 1 to Day 22 and Day 57 to Day 78)
Number of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Measured: Up to 28 days after each vaccination (Day 1 to Day 29 and Day 57 to Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start6 Feb 2023
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687279
- Sponsor's protocol ID
- VAD00014
- Other IDs
- U1111-1278-3910
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2023
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Observer-blind, Placebo-controlled, Multi-center Study of a Live Attenuated Respiratory Syncytial Virus Vaccine to Assess the Vaccine Virus' Transmissibility in Household or Daycare Center Settings, Shedding, and Genetic Stability, and to Describe the Immunogenicity and Safety of the Vaccine in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
- ClinicalTrials.gov ID
- NCT05687279
- Acronym / sponsor ID
- VAD00014
- Conditions
- Respiratory Syncytial Virus Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age.
Detailed description
The duration of each participant's participation is up to 8 months, including the 6 months safety follow-up phone call after the second study intervention administration for the pediatric participants The treatment administration for the pediatric participants will be on D01 and D57 (1 intranasal administration each).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSVt Vaccine Group | Experimental | Biological: RSVt Vaccine2 intranasal administrations (56 days apart) of the RSVt vaccine at D01 and D57 |
| Control Group | Placebo comparator | Other: Control Group2 intranasal administrations (56 days apart) of the placebo at D01 and D57 |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6 months to < 24 months on the day of inclusion (from the day of the 6 months after birth to the day before the 2nd birthday)
- Participants who are healthy as determined by medical evaluation including medical history.
- Born at full term of pregnancy (≥ 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
- Attends a daycare facility at least 3 days per week and 4 hours per day at which the participant would be in a contact group/playroom of at least one other child 6 to < 24 months of age who will participate in this study or is a member of a household, which includes at least one other child 6 to < 24 months of age who will participate in this study
Key exclusion criteria (25 listed)
- 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
- 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 COVID-19 at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSVt VaccinePharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal | Biological | RSVt Vaccine Group |
| Control GroupPharmaceutical Form: Suspension of virus in a nasal spray Route of Administration: Intranasal | Other | Control Group |
Primary outcome
Percentage of Placebo Receiving Pediatric Participants With Vaccine Virus Detected in Nasal Swabs After the First Vaccination
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 4, 8, 11, 15, 18 and 22
Nasal swabs were collected to assess the presence of vaccine virus after first vaccination. Vaccine virus transmission was defined as presence of detected vaccine virus confirmed by RSVt quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay (vaccine virus shedding >=lower limit of detection [LOD=2.80 log10 copies/mL]) in pediatric participants receiving placebo. Percentages are rounded off to the tenth decimal place.
Titer of Vaccine Virus Shedding in All Pediatric Participants Detected in Nasal Swabs
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 4, 8, 11, 15, 18, 22, 64 and 71
Nasal swabs were collected to assess the shedding of the attenuated RSV vaccine strain and quantified by RSVt qRT PCR assay. Quantified virus shedding was defined as vaccine virus shedding >=lower limit of quantification (LLOQ=3.37 log10 copies/mL).
Percentage of Placebo Receiving Pediatric Participants With Detected Shedding Who Showed Any Genetic Sequence Variation After Each Vaccination
Time frame: Up to 21 days after each vaccination (Day 1 to Day 22 and Day 57 to Day 78)
Nasal swabs were collected to identify the difference in genetic sequence of mutated vaccine virus segments compared to the reference strain vaccine virus isolates in the vaccine virus positive swabs from pediatric participants receiving placebo after each vaccination. Detected virus shedding was defined as vaccine virus shedding >=LOD (2.80 log10 copies/mL).
5 secondary outcomes
Geometric Mean Titers (GMTs) of RSV A Serum Neutralizing Antibody (nAb) Titers
Time frame: Pre-vaccination on Day 1 (first vaccination) and Day 57 (second vaccination) and up to 28 days after second vaccination, Day 85
Secondary: Geometric Mean Titers of RSV Serum Anti-F Immunoglobulin G (IgG) Enzyme-linked Immuno-adsorbant Assay (ELISA) Antibody
Time frame: Pre-vaccination on Day 1 (first vaccination) and Day 57 (second vaccination) and up to 28 days after second vaccination, Day 85
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Time frame: Up to 30 minutes after each vaccination (Days 1 and 57)
Number of Participants With Solicited Administration Site Reactions and Systemic Reactions
Time frame: Up to 21 days after each vaccination (Day 1 to Day 22 and Day 57 to Day 78)
Number of Participants With Unsolicited Adverse Events
Time frame: Up to 28 days after each vaccination (Day 1 to Day 29 and Day 57 to Day 85)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RSVt Vaccine in people with Respiratory Syncytial Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Puerto Rico, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Placebo Receiving Pediatric Participants With Vaccine Virus Detected in Nasal Swabs After the First Vaccination (time frame: Pre-vaccination on Day 1 and post-vaccination on Days 4, 8, 11, 15, 18 and 22). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.