Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 1350

Inclusion Criteria

1. Aged 6 months to < 22 months on the day of inclusion
2. Participants who are healthy as determined by medical evaluation including medical history.
3. 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
4. Informed consent form has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations)
5. Participant and parent(s)/LAR are able to attend all scheduled visits and to comply with all study procedures

Exclusion Criteria

1. 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)
2. 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
3. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
4. History of medically diagnosed wheezing
5. 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.
6. Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
7. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post dose 2

Secondary Outcome Measures

Name	Time	Method
Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2;Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain leading to hospitalization > 21 days post-dose 2

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