A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

Status Terminated

Clinical Trial 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.

Clinical Trial Description

A Phase 2b, double-blind, randomized, and controlled study to evaluate the efficacy of MEDI7510 in approximately 1,900 adult participants, globally, 60 years or older. Participants will be randomized in a 1:1 ratio to receive a single intramuscular dose of each of 2 study vaccines in contralateral arms: MEDI7510 + IIV or placebo + IIV in Season 1.

Participants who receive MEDI7510 in the Northern Hemisphere will be re-randomized and blinded in Season 2 to receive either MEDI7510 + IIV or placebo + IIV in a 1:1 ratio. Clinical efficacy will not be assessed in Season 2; however the safety of revaccination will be assessed in Season 2. ;

Study Design

Related Conditions & MeSH terms

Respiratory Syncytial Virus

Clinical Trial Details

NCT number	NCT02508194
Study type	Interventional
Source	MedImmune LLC
Contact
Status	Terminated
Phase	Phase 2
Start date	September 29, 2015
Completion date	November 7, 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04528719` - A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive	Phase 1
Active, not recruiting	`NCT06060457` - A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age	Phase 3
Terminated	`NCT01757496` - Cough Assist in Bronchiolitis	N/A
Completed	`NCT00100373` - RSV Challenge in Healthy Adults	N/A
Completed	`NCT03524118` - Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)	Phase 1/Phase 2
Active, not recruiting	`NCT05572658` - Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
Recruiting	`NCT06067230` - A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults	Phase 3
Completed	`NCT00246480` - RSV Disease in the Elderly
Active, not recruiting	`NCT06097299` - A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus	Phase 2
Completed	`NCT00889070` - Respiratory Events Among Premature Infants	N/A
Unknown status	`NCT00613184` - Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses	N/A
Completed	`NCT05559905` - Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)	Phase 2
Active, not recruiting	`NCT05127434` - A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age	Phase 2/Phase 3
Terminated	`NCT04978337` - A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection	Phase 2
Recruiting	`NCT06143046` - A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers	Phase 2
Active, not recruiting	`NCT05397223` - A Study of Modified mRNA Vaccines in Healthy Adults	Phase 1
Completed	`NCT02472548` - A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine	Phase 1
Completed	`NCT01562938` - MEDI-557 Adult Dosing	Phase 1
Completed	`NCT01734668` - Sofia RSV FIA Field Study	N/A
Recruiting	`NCT06325657` - A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants	Phase 3