CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 363 enrolled
Drug / intervention
MEDI7510 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02289820
NCT02289820Phase 1Completed
CompareCT.gov

A Phase 1b Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults

MedImmune LLC·interventional·Posted Nov 13, 2014·Updated Mar 15, 2018

In Brief

A Phase 1 clinical trial evaluating MEDI7510 and IIV for Respiratory Syncytial Virus (RSV). Completed, enrolled 363 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus (RSV)
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 13, 2014
Enrollment StartJan 5, 2015
Primary CompletionFeb 24, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.6 years ago

Interventions

MEDI7510biological

RSV sF antigen plus adjuvant

IIVbiological

Marketed Inactivated Influenza Vaccine