Status:
COMPLETED
Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
6-21 years
Brief Summary
The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed fo...
Detailed Description
The duration of the study will be 6 months for each participant.
Eligibility Criteria
Inclusion
- Aged 6 months to \< 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month 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 are enrolled in the study
Exclusion
- 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)
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- 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
- Member of a household that contains an immunocompromised individual, including, but not limited to:
- a person who is human immunodeficiency virus (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
- Participant's mother previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding
- Receipt or planned receipt of any of the following vaccines:
- Any intranasal live attenuated vaccine within the 28 days prior to enrollment
- Any injectable live attenuated vaccine within the 28 days prior to and after enrollment
- 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
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Key Trial Info
Start Date :
July 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 2 2024
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT05964582
Start Date
July 11 2023
End Date
July 2 2024
Last Update
September 19 2024
Active Locations (15)
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1
Quality Clinical Research - 10040 Regency Cir - HyperCore - PPDS Site Number : 8400001
Omaha, Nebraska, United States, 68114-3755
2
Senders Pediatrics Site Number : 8400002
Cleveland, Ohio, United States, 44121-4243
3
Investigational Site Number : 2460002
Helsinki, Finland, 00100
4
Investigational Site Number : 2460001
Jarvenpaa, Finland, 04400