VAS00006: Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalizations) in all infants under 12 months of age who are not eligible to receive palivizumab.
The visit frequency will be 1 in-person dosing/randomization visit, with monthly safety follow-up electronic contacts through the first 6 months post dosing/randomization. The study will also include a 12-month (Day 366) final follow-up telephone call.
The study duration will be 12 months post-dosing/randomization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
The duration of each participant's participation will be 12 months post-dosing/randomization.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nirsevimab 1 intramuscular injection at Day 01 |
Drug: Nirsevimab
Pharmaceutical Form: Solution for Injection Route of Administration: Intramuscular
|
| No Intervention: No preventive intervention for RSV No intervention |
Outcome Measures
Primary Outcome Measures
- Overall incidence of RSV LRTI hospitalization through the RSV season [Up to 180 days post-dosing/randomization]
Number of RSV LRTI hospitalization through the RSV season.
Secondary Outcome Measures
- Incidence of very severe RSV LRTI through the RSV season [Up to 180 days post-dosing/randomization]
Number of very severe RSV LRTI through the RSV season. Severe RSV LRTI are defined as confirmed RSV hospitalization for LRTI with an oxygen saturation (SaO2) < 90% (at any time) and oxygen supplementation.
- Incidence of hospitalization for LRTI through the RSV season in each country [Up to 180 days post-dosing/randomization]
Number of RSV LRTI hospitalization in each country through the RSV season.
- Overall hospitalization for allcause LRTI in all 3 countries combined throughout the RSV season [Up to 180 days post-dosing/randomization]
Number of RSV LRTI hospitalization in all 3 countries combined through the RSV season.
- Incidence (overall and in each country) of RSV LRTI hospitalization throughout 150 days post-dosing/randomization [Day 151]
Number of RSV LRTI hospitalization, overall and in each country, throughout 150 days post-dosing/randomization.
- Incidence of very severe RSV LRTI in all 3 countries combined through 150 days post-dosing/randomization [Day 151]
Number of very severe RSV LRTI in all 3 countries combined through 151 days post-dosing/randomization. Severe RSV LRTI are defined as confirmed RSV hospitalization for LRTI with an oxygen saturation (SaO2) < 90% (at any time) and oxygen supplementation.
Eligibility Criteria
Criteria
Inclusion Criteria:
Aged 0 to 12 months (calendar age) who are entering their first RSV season on the day of inclusion Informed consent form has been signed and dated by the parent(s) or other LAR(s) (and by an independent witness if required by local regulations) Participant and parent/LAR are able to attend the scheduled visit and to comply with all study procedures
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)
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Active confirmed RSV infection at the time of dosing/randomization
-
Active LRTI at the time of dosing/randomization
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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
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Laboratory confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular injection
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Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
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Any condition that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
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Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
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Mother of the infant participant was administered an RSV vaccine during her pregnancy with the infant participant
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Receipt of any monoclonal antibody by the infant participant
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Receipt of immune globulins, blood or blood-derived products in the past 3 months by the infant participant
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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
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Eligible to receive palivizumab at time of inclusion (as per local guidelines)
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In an emergency setting or hospitalized involuntarily
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Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
- AstraZeneca
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAS00006
- U1111-1272-2514
- 2022-000099-20