None listed
Conditions
Interventions
Intervention1: nil: It is an observational study. Intervention or comparator agent is not applicable.
Sponsors
Sanofi Pasteur Inc.
Eligibility
Inclusion criteria
Inclusion criteria: Participants are eligible for the study only if all of the following criteria are met: Age I01: Aged 6 months to Type of participant and disease characteristics I02: Participants who are healthy as determined by medical evaluation including medical history I03: Born at full term of pregnancy (ââ?°Â¥ 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: ââ?¬Å?Medically stableââ?¬? 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 are enrolled in the study Informed Consent I04: 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) OTHER INCLUSIONS I05: Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures
Exclusion criteria
Exclusion criteria: Participants are not eligible for the study if any of the following criteria are met: Medical conditions E01: 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) E02: Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion. E03: 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 E04: Member of a household that contains an immunocompromised individual, including, but not limited to: ââ?¬Â¢ a person who is human immunodeficiency virus (HIV) infected ââ?¬Â¢ a person who has received chemotherapy within the 12 months prior to study enrollment ââ?¬Â¢ a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents ââ?¬Â¢ a person living with a solid organ or bone marrow transplant Prior/concomitant therapy E05: Participantââ?¬•s mother previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding E06: Receipt or planned receipt of any of the following vaccines: ââ?¬Â¢ Any intranasal live attenuated vaccine within the 28 days prior to enrollment ââ?¬Â¢ Any injectable live attenuated vaccine within the 28 days prior to and after enrollment E07: Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin or RSV monoclonal antibody) less than 6 months before enrollment E08: Receipt of immune globulins, blood or blood-derived products in the past 3 months Prior/concurrent clinical study experience E09: 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 Other exclusions E10: Deprived of freedom in an emergency setting, or hospitalized involuntarily E11: Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study If the participant has a primary physician who is not the investigator, the site should contact this physician with the participantââ?¬•s parents / LARââ?¬•s consent to inform this physician of the participantââ?¬•s participation in the study. In addition, the site should ask this primary physician to verify exclusion criteria relating to previous therapies, such as receipt of blood products or previous vaccines.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the baseline RSV seroprevalence for each age group (overall & by country) 2. To assess the incidence during the study of RT-PCR confirmed RSV ARD & LRTD by month, by age group, by baseline serostatus, & by severity (overall & by country) 3. To assess the incidence during the study of RT-PCR confirmed RSV ARD & LRTD for each strain (overall & by country) 4. To describe the incidence during the study of clinically diagnosed RSV ARD & LRTD 5. To describe the incidence during the study of all-cause acute otitis media (AOM) 6. To describe the association between RTPCR confirmed RSV ARD & LRTD & RSV antibodies at baseline Timepoint: At Day 01 | — |
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the baseline RSV seroprevalence, overall & by country 2. To assess the incidence during the study of RT PCR confirmed RSV ARD & LRTD, overall and by countryTimepoint: At Day 01 | — |
Countries
Colombia, Finland, Ghana, Honduras, India, Spain, Thailand, United States of America
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical development Pvt Ltd.
Outcome results
None listed