Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

This study has been completed.

Study NCT00233064 Information provided by MedImmune LLC

First Received: October 3, 2005 Last Updated: March 27, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Condition:	Chronic Lung Disease
Interventions:	Biological: Lyophilized Palivizumab Biological: Liquid Palivizumab

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 417 subjects were randomized into the study at 51 sites in the United States between 20 October 2005 and 02 October 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 4 subjects at site #1022 who received all 5 doses of study drug (per drug accountability records) had no further information including case report form that could be obtained. These 4 subjects were excluded from all data analyses.

Reporting Groups

	Description
Liquid Palivizumab	Liquid Palivizumab, 15 mg/kg IM q30 days X 5
Lyophilized Palivizumab	Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Liquid Palivizumab	Liquid Palivizumab, 15 mg/kg IM q30 days X 5
Lyophilized Palivizumab	Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5

Baseline Measures

	Liquid Palivizumab	Lyophilized Palivizumab	Total
Number of Participants [units: participants]	211	202	413
Age [units: months] Mean ± Standard Deviation	4.56 ± 4.50	4.00 ± 4.16	4.29 ± 4.34
Gender [units: participants]
Female	104	99	203
Male	107	103	210
Region of Enrollment [units: participants]
United States	211	202	413
Chronic Lung Disease at Prematurity [units: Participants]
Yes	35	26	61
No	176	176	352
Race/Ethnicity [units: Participants]
American Indian or Alaska Native	0	0	0
Asian	1	3	4
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	25	24	49
White	151	149	300
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Hispanic	22	14	36
Other	12	12	24
Gestational Age at Birth [units: Weeks] Mean ± Standard Deviation	32.4 ± 2.7	32.7 ± 2.5	32.5 ± 2.6
Weight at Day 0 [units: Kilogram] Mean ± Standard Deviation	5.326 ± 2.274	5.079 ± 2.264	5.205 ± 2.270