Trial Outcomes & Findings for Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season (NCT NCT00316264)
NCT ID: NCT00316264
Last Updated: 2012-12-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Day 0 - Day 150
Results posted on
2012-12-11
Participant Flow
It was anticipated that approximately 240 children (80 in each group) would be enrolled from the southern hemisphere during the upcoming RSV season (2006).
Children were randomized into one of three regimens in a 1:1:1 ratio; the first group received 2 doses of motavizumab followed by 3 doses of palivizumab; the second group received 2 doses of palivizumab followed by 3 doses of motavizumab; and the third group received 5 doses of motavizumab.
Participant milestones
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
Overall Study
STARTED
|
83
|
84
|
93
|
|
Overall Study
COMPLETED
|
77
|
77
|
87
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
6
|
Reasons for withdrawal
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal of Consent
|
3
|
5
|
6
|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
Baseline Characteristics
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
Baseline characteristics by cohort
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=83 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=84 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=93 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
3.68 months
STANDARD_DEVIATION 3.13 • n=93 Participants
|
3.35 months
STANDARD_DEVIATION 2.25 • n=4 Participants
|
3.92 months
STANDARD_DEVIATION 2.43 • n=27 Participants
|
3.66 months
STANDARD_DEVIATION 2.62 • n=483 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
118 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
142 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 150Population: The safety population included all randomized subjects who received study drug and had any safety follow-up.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=83 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=83 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=93 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
19 participants
|
7 participants
|
11 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 150Population: The safety population included all randomized subjects who received study drug and had any safety follow-up.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=83 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=83 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=93 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
Number of Subjects Reporting Adverse Events (AEs)
|
77 participants
|
75 participants
|
83 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 150Population: The safety population included all randomized subjects who received study drug and had any safety follow-up.
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=83 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=83 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=93 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Alanine aminotransferase increased
|
1 participants
|
1 participants
|
5 participants
|
|
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Hepatic enzyme increased
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Liver function test abnormal
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Blood urea increased
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Aspartate aminotransferase increased
|
2 participants
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 0Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=76 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=75 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=85 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Serum Concentrations of Motavizumab at Day 0
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
SECONDARY outcome
Timeframe: Day 60Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=67 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=70 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=72 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Trough Serum Concentrations of Motavizumab at Day 60
|
74.74 μg/mL
Standard Deviation 27.50
|
0.9417 μg/mL
Standard Deviation 2.287
|
78.02 μg/mL
Standard Deviation 28.98
|
SECONDARY outcome
Timeframe: Day 150Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=53 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=54 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=62 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Trough Serum Concentrations of Motavizumab at Day 150
|
8.801 μg/mL
Standard Deviation 5.682
|
93.05 μg/mL
Standard Deviation 30.97
|
105.8 μg/mL
Standard Deviation 37.49
|
SECONDARY outcome
Timeframe: 120-150 days post final dosePopulation: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=73 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=72 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=83 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
|
0.5078 μg/mL
Standard Deviation 1.031
|
7.586 μg/mL
Standard Deviation 5.152
|
10.01 μg/mL
Standard Deviation 6.341
|
SECONDARY outcome
Timeframe: Day 0Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=73 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=72 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=83 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Serum Concentrations of Palivizumab at Day 0
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
SECONDARY outcome
Timeframe: Day 60Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=66 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=66 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=69 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Trough Serum Concentrations of Palivizumab at Day 60
|
8.103 μg/mL
Standard Deviation 6.907
|
87.37 μg/mL
Standard Deviation 17.41
|
8.795 μg/mL
Standard Deviation 6.578
|
SECONDARY outcome
Timeframe: Day 150Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=52 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=54 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=60 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Trough Serum Concentrations of Palivizumab at Day 150
|
107.4 μg/mL
Standard Deviation 30.21
|
22.89 μg/mL
Standard Deviation 5.631
|
12.99 μg/mL
Standard Deviation 7.472
|
SECONDARY outcome
Timeframe: 120-150 days post final dosePopulation: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=72 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=71 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=81 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
|
7.667 μg/mL
Standard Deviation 7.719
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
NA μg/mL
Standard Deviation NA
Values were below the level of detection.
|
SECONDARY outcome
Timeframe: Day 0Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=77 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=80 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=89 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Motavizumab at Day 0
|
0 participants with detected antibody
|
1 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: Day 60Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=76 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=82 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=90 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Motavizumab at Day 60
|
0 participants with detected antibody
|
0 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: Day 150Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=73 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=75 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=84 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Motavizumab at Day 150
|
1 participants with detected antibody
|
1 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: 120 - 150 days post final dosePopulation: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=75 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=74 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=84 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
|
3 participants with detected antibody
|
1 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: At any timePopulation: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=79 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=83 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=91 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Motavizumab at Any Time
|
4 participants with detected antibody
|
2 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: Day 0Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=76 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=78 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=86 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Palivizumab at Day 0
|
0 participants with detected antibody
|
0 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: Day 60Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=76 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=82 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=89 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Palivizumab at Day 60
|
1 participants with detected antibody
|
1 participants with detected antibody
|
1 participants with detected antibody
|
SECONDARY outcome
Timeframe: Day 150Population: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=73 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=75 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=84 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Palivizumab at Day 150
|
2 participants with detected antibody
|
1 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: 120 - 150 days post final posePopulation: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=74 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=74 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=83 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
|
3 participants with detected antibody
|
0 participants with detected antibody
|
0 participants with detected antibody
|
SECONDARY outcome
Timeframe: At any timePopulation: The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Outcome measures
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=82 Participants
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=83 Participants
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=90 Participants
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
The Immunogenicity of Palivizumab at Any Time
|
4 participants with detected antibody
|
2 participants with detected antibody
|
1 participants with detected antibody
|
Adverse Events
Motavizumab (MEDI-524) Followed by Palivizumab
Serious events: 19 serious events
Other events: 75 other events
Deaths: 0 deaths
Palivizumab Followed by Motavizumab (MEDI-524)
Serious events: 7 serious events
Other events: 74 other events
Deaths: 0 deaths
Motavizumab (MEDI-524) Control
Serious events: 11 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=83 participants at risk
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=83 participants at risk
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=93 participants at risk
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
Eye disorders
Visual disturbance
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
INFANTILE COLIC
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
BRONCHIOLITIS
|
7.2%
6/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 3 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
BRONCHITIS
|
1.2%
1/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
BRONCHITIS VIRAL
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
CROUP INFECTIOUS
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
GASTROENTERITIS
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
PNEUMONIA
|
3.6%
3/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
PNEUMONIA PARAINFLUENZAE VIRAL
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLIT
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
SEPSIS
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
STAPHYLOCOCCAL SCALDED SKIN SYNDROME
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
APNOEA
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
Other adverse events
| Measure |
Motavizumab (MEDI-524) Followed by Palivizumab
n=83 participants at risk
2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Palivizumab Followed by Motavizumab (MEDI-524)
n=83 participants at risk
2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
Motavizumab (MEDI-524) Control
n=93 participants at risk
5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
7.2%
6/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 3 • Day 0 - Day 150
Safety population
|
|
Eye disorders
CONJUNCTIVITIS
|
7.2%
6/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
13.3%
11/83 • Number of events 11 • Day 0 - Day 150
Safety population
|
17.2%
16/93 • Number of events 16 • Day 0 - Day 150
Safety population
|
|
Blood and lymphatic system disorders
ANAEMIA NEONATAL
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
4.3%
4/93 • Number of events 4 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.8%
4/83 • Number of events 5 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 3 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.2%
6/83 • Number of events 8 • Day 0 - Day 150
Safety population
|
7.2%
6/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
6.5%
6/93 • Number of events 10 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
DIARRHOEA
|
14.5%
12/83 • Number of events 13 • Day 0 - Day 150
Safety population
|
15.7%
13/83 • Number of events 15 • Day 0 - Day 150
Safety population
|
11.8%
11/93 • Number of events 13 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
FLATULENCE
|
1.2%
1/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 5 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
4.8%
4/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
8.4%
7/83 • Number of events 9 • Day 0 - Day 150
Safety population
|
7.5%
7/93 • Number of events 7 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
INFANTILE COLIC
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
4.3%
4/93 • Number of events 4 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
TEETHING
|
12.0%
10/83 • Number of events 24 • Day 0 - Day 150
Safety population
|
10.8%
9/83 • Number of events 14 • Day 0 - Day 150
Safety population
|
17.2%
16/93 • Number of events 27 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Gastrointestinal disorders
VOMITING
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
General disorders
INJECTION SITE ERYTHEMA
|
3.6%
3/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
10.8%
9/83 • Number of events 9 • Day 0 - Day 150
Safety population
|
8.6%
8/93 • Number of events 13 • Day 0 - Day 150
Safety population
|
|
General disorders
IRRITABILITY
|
12.0%
10/83 • Number of events 27 • Day 0 - Day 150
Safety population
|
13.3%
11/83 • Number of events 32 • Day 0 - Day 150
Safety population
|
11.8%
11/93 • Number of events 43 • Day 0 - Day 150
Safety population
|
|
General disorders
PYREXIA
|
7.2%
6/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
9.6%
8/83 • Number of events 8 • Day 0 - Day 150
Safety population
|
11.8%
11/93 • Number of events 11 • Day 0 - Day 150
Safety population
|
|
Immune system disorders
IMMUNISATION REACTION
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
4.8%
4/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
BRONCHIOLITIS
|
7.2%
6/83 • Number of events 7 • Day 0 - Day 150
Safety population
|
7.2%
6/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
BRONCHITIS
|
16.9%
14/83 • Number of events 21 • Day 0 - Day 150
Safety population
|
24.1%
20/83 • Number of events 27 • Day 0 - Day 150
Safety population
|
20.4%
19/93 • Number of events 29 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
CANDIDA NAPPY RASH
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
CANDIDIASIS
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
GASTROENTERITIS
|
8.4%
7/83 • Number of events 8 • Day 0 - Day 150
Safety population
|
4.8%
4/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
5.4%
5/93 • Number of events 5 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
GASTROENTERITIS ROTAVIRUS
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
GENITAL CANDIDIASIS
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.6%
3/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
LARYNGITIS
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.6%
3/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
8.4%
7/83 • Number of events 12 • Day 0 - Day 150
Safety population
|
7.2%
6/83 • Number of events 8 • Day 0 - Day 150
Safety population
|
6.5%
6/93 • Number of events 11 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
NASOPHARYNGITIS
|
30.1%
25/83 • Number of events 35 • Day 0 - Day 150
Safety population
|
31.3%
26/83 • Number of events 40 • Day 0 - Day 150
Safety population
|
24.7%
23/93 • Number of events 37 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
ORAL CANDIDIASIS
|
2.4%
2/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
6.0%
5/83 • Number of events 5 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
OTITIS MEDIA
|
4.8%
4/83 • Number of events 5 • Day 0 - Day 150
Safety population
|
4.8%
4/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
4.3%
4/93 • Number of events 4 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
5.4%
5/93 • Number of events 5 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
PHARYNGITIS
|
8.4%
7/83 • Number of events 7 • Day 0 - Day 150
Safety population
|
4.8%
4/83 • Number of events 4 • Day 0 - Day 150
Safety population
|
10.8%
10/93 • Number of events 10 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
RASH PUSTULAR
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
RHINITIS
|
12.0%
10/83 • Number of events 12 • Day 0 - Day 150
Safety population
|
16.9%
14/83 • Number of events 18 • Day 0 - Day 150
Safety population
|
8.6%
8/93 • Number of events 8 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
20.5%
17/83 • Number of events 28 • Day 0 - Day 150
Safety population
|
18.1%
15/83 • Number of events 22 • Day 0 - Day 150
Safety population
|
19.4%
18/93 • Number of events 25 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
VARICELLA
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
VIRAL INFECTION
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 4 • Day 0 - Day 150
Safety population
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 3 • Day 0 - Day 150
Safety population
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
5.4%
5/93 • Number of events 5 • Day 0 - Day 150
Safety population
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Investigations
BLOOD UREA INCREASED
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 3 • Day 0 - Day 150
Safety population
|
|
Investigations
CARDIAC MURMUR
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Nervous system disorders
HYPERTONIA
|
6.0%
5/83 • Number of events 5 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Nervous system disorders
PSYCHOMOTOR SKILLS IMPAIRED
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Psychiatric disorders
AGITATION
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
2.4%
2/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Psychiatric disorders
BREATH HOLDING
|
2.4%
2/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/93 • Day 0 - Day 150
Safety population
|
|
Reproductive system and breast disorders
GENITAL RASH
|
1.2%
1/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 3 • Day 0 - Day 150
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.2%
6/83 • Number of events 7 • Day 0 - Day 150
Safety population
|
4.8%
4/83 • Number of events 5 • Day 0 - Day 150
Safety population
|
5.4%
5/93 • Number of events 6 • Day 0 - Day 150
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
8.4%
7/83 • Number of events 8 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
3.2%
3/93 • Number of events 3 • Day 0 - Day 150
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
3.6%
3/83 • Number of events 12 • Day 0 - Day 150
Safety population
|
6.0%
5/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
18.1%
15/83 • Number of events 21 • Day 0 - Day 150
Safety population
|
9.6%
8/83 • Number of events 11 • Day 0 - Day 150
Safety population
|
10.8%
10/93 • Number of events 12 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
2.4%
2/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
1.1%
1/93 • Number of events 1 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
|
6.0%
5/83 • Number of events 5 • Day 0 - Day 150
Safety population
|
12.0%
10/83 • Number of events 12 • Day 0 - Day 150
Safety population
|
10.8%
10/93 • Number of events 16 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 2 • Day 0 - Day 150
Safety population
|
4.3%
4/93 • Number of events 6 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
6.0%
5/83 • Number of events 7 • Day 0 - Day 150
Safety population
|
4.3%
4/93 • Number of events 7 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.6%
3/83 • Number of events 3 • Day 0 - Day 150
Safety population
|
6.0%
5/83 • Number of events 6 • Day 0 - Day 150
Safety population
|
4.3%
4/93 • Number of events 6 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
0.00%
0/83 • Day 0 - Day 150
Safety population
|
2.2%
2/93 • Number of events 2 • Day 0 - Day 150
Safety population
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
4.8%
4/83 • Number of events 5 • Day 0 - Day 150
Safety population
|
1.2%
1/83 • Number of events 1 • Day 0 - Day 150
Safety population
|
5.4%
5/93 • Number of events 5 • Day 0 - Day 150
Safety population
|
Additional Information
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. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER