CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 246 enrolled
Drug / intervention
Placebo +6 morebiological
Likely dose
RSV sF 20 mcgfrom 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/NCT02115815
NCT02115815Phase 1Completed

A Phase 1a Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults

MedImmune LLC·interventional·Posted Apr 16, 2014·Updated Oct 21, 2016

In Brief

A Phase 1 clinical trial evaluating Placebo, RSV sF 20 mcg, and 5 other interventions for Respiratory Syncytial Virus (RSV). Completed, enrolled 246 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 16, 2014
Enrollment StartApr 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.2 years ago

Interventions

Placebobiological

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

RSV sF 20 mcgbiological

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

MEDI7510 (20 mcg RSV sF)biological

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

RSV sF 50 mcgbiological

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

MEDI7510 (50 mcg RSV sF)biological

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

RSV sF 80 mcgbiological

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

MEDI7510 (80 mcg RSV sF)biological

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