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Virus Therapy

MEDI7510 + IIV for Respiratory Syncytial Virus

Phase 2
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 29, and end of season 1 (approximately 1 year)
Awards & highlights

Summary

This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 29, and end of season 1 (approximately 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 29, and end of season 1 (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental disorders
Secondary outcome measures
Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay
Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MEDI7510 + IIVExperimental Treatment2 Interventions
Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
Group II: Placebo + Inactivated Influenza Vaccine (IIV)Active Control2 Interventions
Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI7510
2015
Completed Phase 1
~370
IIV
2017
Completed Phase 4
~720

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Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
792,009 Total Patients Enrolled
~192 spots leftby Sep 2025
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