Study identifier:MI-CP169
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Motavizumab Prophylaxis on Reduction of the Incidence of Serious Early Childhood Wheezing in Preterm Infants
Wheezing
Phase 3
Yes
-
All
0
Interventional
N/A - 6 Months
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jul 2012 by MedImmune Inc.
MedImmune Inc.
-
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early childhood wheezing from their 2nd through 3rd birthdays.
The primary objective of this study is assess the efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection during the first RSV season for the reduction of the incidence of serious early childhood wheezing in preterm infants between their 2nd and 3rd birthdays.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 Motavizumab | Biological/Vaccine: Motavizumab 15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections Other Name: MEDI-524 |
Placebo Comparator: 2 Placebo | Other: Placebo 15 mg/kg administered by IM injection every 30 days during the RSV season for a total of 5-6 injections |
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