E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
respiratory syncytial virus (RSV) infection |
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E.1.1.1 | Medical condition in easily understood language |
respiratory syncytial virus (RSV) infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061603 |
E.1.2 | Term | Respiratory syncytial virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To assess the efficacy of nirsevimab in preventing RSV LRTI hospitalization compared to no intervention |
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E.2.2 | Secondary objectives of the trial |
- To assess the efficacy of nirsevimab in preventing very severe RSV LRTI compared to no intervention - To assess the efficacy of nirsevimab in preventing RSV LRTI hospitalization compared to no intervention in each country - To assess the efficacy of nirsevimab in preventing hospitalizations for all-cause LRTI compared to no intervention - To assess the efficacy of nirsevimab in preventing RSV LRTI hospitalization through 150 days post-dosing/randomization (overall and in each country) - To assess the efficacy of nirsevimab in preventing very severe RSV LRTI through 150 days post-dosing/randomization - To assess the efficacy of nirsevimab in preventing hospitalizations for all-cause LRTI through 150 days post-dosing/randomization - To further characterize the safety profile of nirsevimab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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)
- Active confirmed RSV infection at the time of dosing/randomization
- Active LRTI at the time of dosing/randomization
- 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
- Laboratory confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular injection
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- Any condition that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- 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
- Mother of the infant participant was administered an RSV vaccine during her pregnancy with the infant participant
- Receipt of any monoclonal antibody by the infant participant
- Receipt of immune globulins, blood or blood-derived products in the past 3 months by the infant participant
- 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
- Eligible to receive palivizumab at time of inclusion (as per local guidelines)
- In an emergency setting or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall incidence of RSV LRTI hospitalization through the RSV season: Number of RSV LRTI hospitalization through the RSV season.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 180 days post-dosing/randomization
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E.5.2 | Secondary end point(s) |
1/ Incidence of very severe RSV LRTI through the RSV season: 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.
2/ Incidence of hospitalization for LRTI through the RSV season in each country: Number of RSV LRTI hospitalization in each country through the RSV season.
3/ Overall hospitalization for all cause LRTI in all 3 countries combined throughout the RSV season: Number of RSV LRTI hospitalization in all 3 countries combined through the RSV season.
4/ Incidence (overall and in each country) of RSV LRTI hospitalization throughout 150 days post-dosing/randomization: Number of RSV LRTI hospitalization, overall and in each country, throughout 150 days post-dosing/randomization.
5/ Incidence of very severe RSV LRTI in all 3 countries combined through 150 days post-dosing/randomization: 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1/ to 3/: Up to 180 days post-dosing/randomization
4/, 5/: Day 151 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
1 arm is with no treatment |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 74 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 300 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
France |
Germany |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |