At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 49 enrolled
Drug / intervention
MEDI-534 +2 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.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age
In Brief
A Phase 1 clinical trial evaluating MEDI-534 for Respiratory Viral Infections and 2 related conditions. Completed, enrolled 49 participants across 30 sites.
Detailed Summary
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Viral Infections, Respiratory Syncytial Virus Infections, Parainfluenza Virus 3, Human
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartJul 2007
Primary CompletionNov 2009
Study CompletionApr 2010
TodayJul 2026
First PostedJun 28, 2007
Enrollment StartJul 1, 2007
Primary CompletionNov 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.0 years ago
Interventions
MEDI-534biological
Multiple doses of MEDI-534 or Placebo at 10\^4 TCID50
MEDI-534biological
Multiple doses of MEDI-534 or Placebo at 10 \^5 TCID50.
MEDI-534biological
Multiple doses of MEDI-534 or Placebo at 10\^6 TCID50.