Trial Outcomes & Findings for Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) (NCT NCT00233064)
NCT ID: NCT00233064
Last Updated: 2018-06-27
Results Overview
Presence of anti-palivizumab antibodies
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
417 participants
Primary outcome timeframe
Day 240-300 follow up
Results posted on
2018-06-27
Participant Flow
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.
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.
Participant milestones
| Measure |
Liquid Palivizumab
Liquid Palivizumab, 15 mg/kg IM q30 days X 5
|
Lyophilized Palivizumab
Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
202
|
|
Overall Study
COMPLETED
|
197
|
190
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
Reasons for withdrawal
| Measure |
Liquid Palivizumab
Liquid Palivizumab, 15 mg/kg IM q30 days X 5
|
Lyophilized Palivizumab
Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Relocation
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Moved to Dom. Republic
|
1
|
0
|
Baseline Characteristics
Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)
Baseline characteristics by cohort
| Measure |
Liquid Palivizumab
n=211 Participants
Liquid Palivizumab, 15 mg/kg IM q30 days X 5
|
Lyophilized Palivizumab
n=202 Participants
Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.56 months
STANDARD_DEVIATION 4.50 • n=5 Participants
|
4.00 months
STANDARD_DEVIATION 4.16 • n=7 Participants
|
4.29 months
STANDARD_DEVIATION 4.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
211 participants
n=5 Participants
|
202 participants
n=7 Participants
|
413 participants
n=5 Participants
|
|
Chronic Lung Disease at Prematurity
Yes
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Chronic Lung Disease at Prematurity
No
|
176 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Race/Ethnicity
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity
Black or African American
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity
White
|
151 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Race/Ethnicity
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity
Other
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Gestational Age at Birth
|
32.4 Weeks
STANDARD_DEVIATION 2.7 • n=5 Participants
|
32.7 Weeks
STANDARD_DEVIATION 2.5 • n=7 Participants
|
32.5 Weeks
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Weight at Day 0
|
5.326 Kilogram
STANDARD_DEVIATION 2.274 • n=5 Participants
|
5.079 Kilogram
STANDARD_DEVIATION 2.264 • n=7 Participants
|
5.205 Kilogram
STANDARD_DEVIATION 2.270 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 240-300 follow upPopulation: Participants who received at least 2 doses of study drug and had at least 1 blood sample collected (at baseline or Study Day 240-300) were included in the analysis. This included 206 subjects in Arm 1 and 200 subjects in Arm 2. Of these subjects, 191 (Arm 1) and 188 (Arm 2) had adequate blood samples for analysis. This analysis was per protocol.
Presence of anti-palivizumab antibodies
Outcome measures
| Measure |
Liquid Palivizumab
n=191 Participants
Liquid Palivizumab, 15 mg/kg IM q30 days X 5
|
Lyophilized Palivizumab
n=188 Participants
Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
|
Combined Liquid/Lyophilized Palivizumab
n=379 Participants
|
|---|---|---|---|
|
Number and Percentage of Participants With Immune Reactivity
Number
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number and Percentage of Participants With Immune Reactivity
Percentage
|
0.0 Participants
|
0.5 Participants
|
0.3 Participants
|
Adverse Events
Liquid Palivizumab
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Lyophilized Palivizumab
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liquid Palivizumab
n=211 participants at risk
Liquid Palivizumab, 15 mg/kg IM q30 days X 5
|
Lyophilized Palivizumab
n=202 participants at risk
Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Congenital, familial and genetic disorders
Cleft Lip
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Abscess
|
0.00%
0/211 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Bronchiolitis
|
2.8%
6/211 • Number of events 6 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
1.5%
3/202 • Number of events 3 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Bronchopneumonia
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Cellulitis
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Infectious Croup
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Gastroenteritis
|
0.95%
2/211 • Number of events 2 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.99%
2/202 • Number of events 2 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Infections and infestations
Viral Infection
|
0.95%
2/211 • Number of events 2 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Gastrointestinal disorders
Occult Blood Positive
|
0.00%
0/211 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/211 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Musculoskeletal and connective tissue disorders
Craniosynostosis
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Nervous system disorders
Complex Partial Seizures
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Nervous system disorders
Convulsions
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.47%
1/211 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.00%
0/202 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/211 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/211 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/211 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.50%
1/202 • Number of events 1 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/211 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
0.99%
2/202 • Number of events 2 • Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Hasan S. Jafri, MD
MedImmune, LLC
Phone: 301-398-0000
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER