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Cohort 3: Historical Control Cohort for Respiratory Syncytial Virus (BEAR Trial)

N/A
Recruiting
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months
Awards & highlights

BEAR Trial Summary

The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters. the secondary objectives are: To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis. To estimate the impact of nirsevimab on PCR-confirmed RSV. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis. To estimate the impact of nirsevimab on antibiotic prescription.

BEAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)
Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis
Secondary outcome measures
Incidence of PCR-confirmed RSV (first occurrence of season)
Number of antibiotic prescriptions by National Drug Code (NDC) codes
Number of medical encounters for otitis media by ICD-10 codes
+2 more

Side effects data

From 2023 Phase 2 trial • 100 Patients • NCT04484935
35%
Upper respiratory tract infection
25%
Pyrexia
25%
Vomiting
23%
COVID-19
19%
Diarrhoea
15%
Dermatitis diaper
13%
Rhinorrhoea
12%
Nasopharyngitis
12%
Otitis media
12%
Gastroenteritis
10%
Rhinitis
8%
Cough
8%
Gastroenteritis viral
8%
Gastrointestinal viral infection
8%
Pneumonia
8%
Otitis media acute
6%
Anaemia
6%
Nasal congestion
6%
Lower respiratory tract infection
6%
Hand-foot-and-mouth disease
6%
Viral upper respiratory tract infection
6%
Ear infection
6%
Neutropenia
6%
Abdominal pain
4%
Febrile neutropenia
4%
Conjunctivitis
4%
Constipation
4%
Bacteraemia
4%
Nephrotic syndrome
4%
Klebsiella sepsis
4%
Thrombocytopenia
2%
Dry skin
2%
Rash
2%
Device related sepsis
2%
Malnutrition
2%
Giardiasis
2%
Volvulus
2%
Klebsiella bacteraemia
2%
Urethritis
2%
Iatrogenic injury
2%
Tonsillar hypertrophy
2%
Complication associated with device
2%
Hepatic cytolysis
2%
Transplant rejection
2%
Graft versus host disease
2%
Escherichia pyelonephritis
2%
Gastroenteritis Escherichia coli
2%
Lower respiratory tract infection viral
2%
Staphylococcal bacteraemia
2%
Seizure
2%
Adenoidal hypertrophy
2%
Feeding intolerance
2%
Oral herpes
2%
Postoperative wound infection
2%
Intracranial pressure increased
2%
Pneumonia viral
2%
Sickle cell disease
2%
Serratia sepsis
2%
Gastrostomy failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nirsevimab 200 mg
Nirsevimab 50 mg/100 mg

BEAR Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Infant Cohort with High-Risk ConditionsExperimental Treatment0 Interventions
Infants born < 37 weeks gestational age and those diagnosed with a high-risk condition between birth and the end of the observation period (regardless of gestational age at birth), will be considered infants with high-risk conditions. Infants with high-risk conditions will be excluded from Cohort 1, Cohort 2, and Cohort 3. Descriptive statistics will be separately assessed for this high-risk cohort.
Group II: Cohort 3: Historical Control CohortExperimental Treatment0 Interventions
Full-term (born ≥ 37 weeks gestational age) infants without a high-risk condition from previous RSV seasons 2016-2017, 2017-2018, 2018-2019, 2019-2020, and 2022-2023. The 2020-2021 and 2021-2022 seasons are excluded due to low circulation of RSV during the COVID-19 pandemic. Historical seasons' data are intended for descriptive purpose only, to contextualize the impact of the treatment during the 2023-2024 season.
Group III: Cohort 2: Comparator CohortExperimental Treatment0 Interventions
Full-term (born ≥ 37 weeks gestational age) infants born on or after 01 April 2023, without a high-risk condition, who do not receive nirsevimab before or during the 2023-2024 RSV season.
Group IV: Cohort 1: Nirsevimab-Exposed CohortExperimental Treatment1 Intervention
Full-term (born ≥ 37 weeks gestational age) infants born on or after 01 April 2023, without a high-risk condition, who receive nirsevimab before or during their first RSV season per recommendations, ie, before or during the 2023-2024 RSV season.

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,058,981 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
2024. "BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06325332.
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~22000 spots leftby Apr 2025
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