None listed
Conditions
Interventions
Intervention1: Respiratory Syncytial Virus vaccine: The RSVt vaccine drug product (DP) consists of a frozen liquid formulation with the same histidine-based formulation buffer as the drug substance.
) of RSVt vaccine will contain the live-attenuated RSV.
Control Intervention1: Placebo: Participants will be randomized to receive either RSVt
vaccine or placebo in a 1:1 ratio.
Form: Liquid for nas
Sponsors
Sanofi Pasteur Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 6 months to less than 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. 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
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 completionc 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 Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigatorâ??s discretion 8. Participantâ??s biological motherâ??s previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding. 9. Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration: • Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration • Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed. 10. Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment. Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration. 11. Receipt of immune globulins, blood or blood-derived products in the past 3 months 12. Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment 13. Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure 14. Deprived of freedom in an emergency setting, or hospitalized involuntarily 15. Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after 2 doses, over RSV Season 1Timepoint: 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT PCR confirmed RSV URTD after 2 doses over RSV Season 1 2. To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV associated with the occurrence of LRTD, leading to hospitalization after 2 doses over RSV Season 1Timepoint: 1. 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1). 2. 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1). | — |
Countries
Argentina, Brazil, Chile, China, Colombia, Finland, Germany, Ghana, Honduras, India, Japan, Kenya, Mexico, Nepal, Republic of Korea, South Africa, Spain, Thailand, United Kingdom, United States of America
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed