A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants

Study identifier:MI-CP178

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-old Children and in 2 Month-old Infants

Medical condition

Healthy

Phase

Phase 1/2

Healthy volunteers

Yes

Study drug

-

Sex

All

Actual Enrollment

1338

Study type

Interventional

Age

2 Months - 23 Months

Date

Study Start Date: 01 Jun 2008
Primary Completion Date: 01 Aug 2012
Study Completion Date: 01 Aug 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2014 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria