A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age

Study identifier:MI-CP150

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

An Expanded Phase1/2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-560, A Live, Attenuated Recombinant Parainfluenza Virus Type 3 (PIV3) Vaccine, Administered Intranasally to Healthy Infants 1 to <12 Mos. of Age

Medical condition

Healthy

Phase

Phase 1/2

Healthy volunteers

Yes

Study drug

-

Sex

All

Actual Enrollment

30

Study type

Interventional

Age

1 Months - 11 Months

Date

Study Start Date: 01 Oct 2007
Primary Completion Date: 01 Apr 2009
Study Completion Date: 01 Apr 2009

Study design

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

Verification:

Verified 01 Nov 2011 by MedImmune

Sponsors

MedImmune

Collaborators

-

Inclusion and exclusion criteria