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A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults

NCT02289820 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2018-03-15

Study results available
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Summary

The goal of this study is to evaluate the safety, tolerability and immunogenicity of ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions. This study will also provide preliminary safety and immunogenicity data to support concurrent dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a dose previously assessed in the Phase 1a study.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

MEDI7510

RSV sF antigen plus adjuvant

BIOLOGICAL

IIV

Marketed Inactivated Influenza Vaccine

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Judith Falloon, MD · MedImmune LLC

  • Eric Sheldon, MD · Miami Research Associates

  • Craig Curtis, MD · Compass Research

  • John Ervin, MD · The Center for Pharmaceutical Research

  • Wayne Harper, MD · Wake Research Associates

  • H. Keipp Talbot, MD · Vanderbilt University Medical Center

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
2015-01-05
Primary Completion
2016-02-24
Completion
2016-02-24

Countries

  • United States

Study Locations

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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 NCT02289820 on ClinicalTrials.gov