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Phase 2 N=80 Randomized Quadruple-blind Prevention

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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