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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)
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)

NCT05687279

CompletedPhase 1, Phase 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Respiratory Syncytial Virus Infection

Interventions: RSVt Vaccine, Control Group

Countries: United States, Puerto Rico

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 overview

Sex: ALL

Age: 6 Months to 23 Months

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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 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.
Locations (6)
  • Norfolk, Nebraska, United States
  • Omaha, Nebraska, United States
  • Bayamón, Puerto Rico
  • Carolina, Puerto Rico
  • Guayama, Puerto Rico
  • San Juan, Puerto Rico