Healthy children
Conditions
Interventions
Drug: RSV toddler (RSVt) Vaccine
Pharmaceutical form: Nasal spray suspension, Route of administration: Intranasal
Drug: Placebo
Pharmaceutical form: Nasal spray suspension, Route of administration:
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 6 months to = 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator. - Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (LAR) (and by an independent witness if required by local regulations). - Participant and parent/LAR are able to attend all scheduled visits and comply with all study procedures.
Exclusion criteria
Exclusion criteria: Participants are not eligible for the study if any of the following criteria are met: - 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 intevention 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. - Participant's mother previous receipt of an investigational RSV vaccine during pregnancy or planned administration of an investigational RSV vaccine during breastfeeding. - 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 administration of 1st study vaccine - - 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 - Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin IG or RSV monoclonal antibody) at the time of enrollment. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: - Unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any study intervention administration - Solicited administration site and systemic reactions within 21 days after each study intervention administration - Unsolicited AEs within 28 days after each study intervention administration - AEs of special interest (AESIs) within 28 days after each study intervention administration - Medically-attended AEs (MAAEs) within 28 days after each study intervention administration - Serious AEs (SAEs) throughout the study (ie, from Day 01 to Day 85) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: - RSV A serum neutralizing Ab titers up to 28 days after the second study intervention administration (Day 01 and Day 85) - RSV serum anti-F IgG enzyme-linked immunosorbent assay (ELISA) Ab titers up to 28 days after the second study intervention administration (Day 01 and Day 85) | — |
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed