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A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults

NCT02115815 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2016-10-21

Study results available
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Summary

The purpose of this study is to determine if the administration of single ascending intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

Placebo

Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.

BIOLOGICAL

RSV sF 20 mcg

Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.

BIOLOGICAL

MEDI7510 (20 mcg RSV sF)

Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.

BIOLOGICAL

RSV sF 50 mcg

Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.

BIOLOGICAL

MEDI7510 (50 mcg RSV sF)

Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.

BIOLOGICAL

RSV sF 80 mcg

Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.

BIOLOGICAL

MEDI7510 (80 mcg RSV sF)

Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Eric Sheldon, MD · Miami Research Associates

  • Craig Curtis, MD · Compass Research

  • Steven Bart, MD · Accelovance

  • Judith Falloon, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115815 on ClinicalTrials.gov