Phase 2
N=80
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)
Respiratory Syncytial Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT05687279 ↗Enrolled (actual)
80
Serious AEs
7.7%
Results posted
Jan 2026
Primary outcome: Primary: Percentage of Placebo Receiving Pediatric Participants With Vaccine Virus Detected in Nasal Swabs After the First Vaccination — 0; 0; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RSVt Vaccine (Biological); Control Group (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Placebo Receiving Pediatric Participants With Vaccine Virus Detected in Nasal Swabs After the First Vaccination |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Titer of Vaccine Virus Shedding in All Pediatric Participants Detected in Nasal Swabs |
4.33; 4.33; 4.72; 3.55 | — |
| PRIMARY Percentage of Placebo Receiving Pediatric Participants With Detected Shedding Who Showed Any Genetic Sequence Variation After Each Vaccination |
— | — |
| SECONDARY Geometric Mean Titers (GMTs) of RSV A Serum Neutralizing Antibody (nAb) Titers |
53.4; 47.9; 167; 65.3; 219; 60.0 | — |
| SECONDARY Secondary: Geometric Mean Titers of RSV Serum Anti-F Immunoglobulin G (IgG) Enzyme-linked Immuno-adsorbant Assay (ELISA) Antibody |
92.2; 85.6; 249; 115; 383; 129 | — |
| SECONDARY Number of Participants With Immediate Unsolicited Adverse Events (AEs) |
0; 0 | — |
| SECONDARY Number of Participants With Solicited Administration Site Reactions and Systemic Reactions |
30; 32; 26; 25 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events |
8; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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:
- 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
Data sourced from ClinicalTrials.gov (NCT05687279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.