Trial Outcomes & Findings for Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA (NCT NCT01077271)
NCT ID: NCT01077271
Last Updated: 2012-08-21
Results Overview
The average number of injections administered per participant within a respiratory syncytial virus season.
Recruitment status
COMPLETED
Target enrollment
124 participants
Primary outcome timeframe
One RSV season (5 months)
Results posted on
2012-08-21
Participant Flow
Participant milestones
| Measure |
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
Participants Treated With Palivizumab
|
120
|
|
Overall Study
Number of Participants Analyzed
|
120
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
|
|---|---|
|
Overall Study
Parental desire
|
8
|
|
Overall Study
Screen failure, did not take palivizumab
|
4
|
|
Overall Study
Noncompliance
|
2
|
|
Overall Study
Quota used up (insurance reimb issue)
|
2
|
|
Overall Study
Changed doctors
|
2
|
|
Overall Study
Parents thought too many injections
|
2
|
|
Overall Study
End of RSV season nearly reached
|
1
|
|
Overall Study
Mother unconvinced of the necessity
|
1
|
Baseline Characteristics
Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA
Baseline characteristics by cohort
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Less than 1 month
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Customized
1 month
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Age, Customized
Greater than 1 and less than or equal to 2 months
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Age, Customized
3 months
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Customized
4 to 4.5 months
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Customized
5 months
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Customized
6 months
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Customized
7 months
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
8 months
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Customized
9 months
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
10 months
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Customized
Age not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Gestational age
23 weeks
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Gestational age
28 weeks
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Gestational age
31 weeks
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Gestational age
33 weeks
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Gestational age
34 weeks
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Gestational age
35 weeks
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Body weight
|
3.9 kilograms
STANDARD_DEVIATION 1.4 • n=5 Participants
|
3.8 kilograms
STANDARD_DEVIATION 1.5 • n=7 Participants
|
4.1 kilograms
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.5 kilograms
STANDARD_DEVIATION 1.1 • n=4 Participants
|
3.9 kilograms
STANDARD_DEVIATION 1.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: One RSV season (5 months)Population: Participants who were administered palivizumab were included in the analysis.
The average number of injections administered per participant within a respiratory syncytial virus season.
Outcome measures
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
|
|---|---|---|---|---|---|
|
Number of Injections Per Patient Per Season
|
3.8 Injections administered
Standard Deviation 1.3
|
3.9 Injections administered
Standard Deviation 1.1
|
4.0 Injections administered
Standard Deviation 1.4
|
1.0 Injections administered
Standard Deviation 0.0
|
3.8 Injections administered
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: One RSV season (5 months)Population: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
The body site of injection administration for participants at each study visit.
Outcome measures
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
|
|---|---|---|---|---|---|
|
Body Site of Injections Per Administration
Visit 3: Thigh
|
31 participants
|
42 participants
|
23 participants
|
0 participants
|
96 participants
|
|
Body Site of Injections Per Administration
Visit 7: Thigh
|
2 participants
|
3 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Body Site of Injections Per Administration
Visit 1: Thigh
|
38 participants
|
44 participants
|
29 participants
|
4 participants
|
115 participants
|
|
Body Site of Injections Per Administration
Visit 2: Thigh
|
34 participants
|
43 participants
|
32 participants
|
0 participants
|
109 participants
|
|
Body Site of Injections Per Administration
Visit 3: Other location
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Body Site of Injections Per Administration
Visit 4: Thigh
|
20 participants
|
28 participants
|
22 participants
|
0 participants
|
70 participants
|
|
Body Site of Injections Per Administration
Visit 4: Other location
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Body Site of Injections Per Administration
Visit 5: Thigh
|
15 participants
|
13 participants
|
15 participants
|
0 participants
|
43 participants
|
|
Body Site of Injections Per Administration
Visit 5: Other location
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Body Site of Injections Per Administration
Visit 6: Thigh
|
5 participants
|
3 participants
|
3 participants
|
0 participants
|
11 participants
|
|
Body Site of Injections Per Administration
Visit 6: Other location
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: One RSV season (5 months)Population: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Outcome measures
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
|
|---|---|---|---|---|---|
|
Interval Between Administrations
V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0)
|
33.2 Days
Standard Deviation 12.4
|
34.7 Days
Standard Deviation 12.1
|
30.3 Days
Standard Deviation 4.8
|
NA Days
Standard Deviation NA
No data reported for this subgroup at this time point.
|
33.1 Days
Standard Deviation 10.9
|
|
Interval Between Administrations
V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0)
|
33.4 Days
Standard Deviation 13.9
|
32.5 Days
Standard Deviation 12.9
|
28.4 Days
Standard Deviation 5.5
|
NA Days
Standard Deviation NA
No data reported for this subgroup at this time point.
|
31.3 Days
Standard Deviation 11.2
|
|
Interval Between Administrations
V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0)
|
28.5 Days
Standard Deviation 9.1
|
30.6 Days
Standard Deviation 9.2
|
28.6 Days
Standard Deviation 9.2
|
NA Days
Standard Deviation NA
No data reported for this subgroup at this time point.
|
29.4 Days
Standard Deviation 9.1
|
|
Interval Between Administrations
V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0)
|
34.5 Days
Standard Deviation 9.4
|
41.8 Days
Standard Deviation 48.2
|
32.0 Days
Standard Deviation 5.5
|
NA Days
Standard Deviation NA
No data reported for this subgroup at this time point.
|
36.6 Days
Standard Deviation 30.8
|
|
Interval Between Administrations
V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0)
|
24.8 Days
Standard Deviation 10.3
|
30.0 Days
Standard Deviation 1.7
|
29.5 Days
Standard Deviation 1.7
|
NA Days
Standard Deviation NA
No data reported for this subgroup at this time point.
|
27.5 Days
Standard Deviation 7.2
|
|
Interval Between Administrations
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0)
|
34.0 Days
Standard Deviation 0.0
|
30.0 Days
Standard Deviation 1.7
|
NA Days
Standard Deviation NA
No data reported for this subgroup at this time point.
|
NA Days
Standard Deviation NA
No data reported for this subgroup at this time point.
|
31.6 Days
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: One RSV season (5 months)Population: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
The median dose and range of palivizumab (milligrams) that was administered at each study visit.
Outcome measures
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
|
|---|---|---|---|---|---|
|
Dosage Per Administration
V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4)
|
60.0 milligrams
Full Range 1925.2 • Interval 40.0 to 7500.0
|
50.0 milligrams
Full Range 25.8 • Interval 24.0 to 150.0
|
73.5 milligrams
Full Range 26.2 • Interval 30.0 to 125.0
|
52.5 milligrams
Full Range 24.2 • Interval 50.0 to 100.0
|
60.0 milligrams
Full Range 1134.4 • Interval 24.0 to 7500.0
|
|
Dosage Per Administration
V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0)
|
77.5 milligrams
Full Range 1210.7 • Interval 50.0 to 5000.0
|
70.0 milligrams
Full Range 23.2 • Interval 50.0 to 150.0
|
84.0 milligrams
Full Range 22.0 • Interval 43.0 to 130.0
|
NA milligrams
Full Range 0
No data reported for this subgroup at this time point.
|
79.5 milligrams
Full Range 686.0 • Interval 43.0 to 5000.0
|
|
Dosage Per Administration
V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0)
|
85.0 milligrams
Full Range 3077.5 • Interval 60.0 to 10000.0
|
80.0 milligrams
Full Range 22.7 • Interval 45.0 to 150.0
|
96.0 milligrams
Full Range 21.1 • Interval 58.0 to 140.0
|
NA milligrams
Full Range 0
No data reported for this subgroup at this time point.
|
85.5 milligrams
Full Range 1795.8 • Interval 45.0 to 10000.0
|
|
Dosage Per Administration
V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0)
|
99.0 milligrams
Full Range 1767.4 • Interval 73.0 to 8000.0
|
97.5 milligrams
Full Range 285.3 • Interval 54.0 to 1600.0
|
100.0 milligrams
Full Range 24.1 • Interval 65.0 to 150.0
|
NA milligrams
Full Range 0
No data reported for this subgroup at this time point.
|
100.0 milligrams
Full Range 973.1 • Interval 54.0 to 8000.0
|
|
Dosage Per Administration
V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0)
|
100.0 milligrams
Full Range 7.8 • Interval 80.0 to 111.0
|
100.0 milligrams
Full Range 18.2 • Interval 80.0 to 150.0
|
100.0 milligrams
Full Range 20.1 • Interval 78.0 to 150.0
|
NA milligrams
Full Range 0
No data reported for this subgroup at this time point.
|
100.0 milligrams
Interval 78.0 to 150.0
|
|
Dosage Per Administration
V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0)
|
100.0 milligrams
Full Range 0 • Interval 100.0 to 100.0
|
100.0 milligrams
Full Range 0 • Interval 100.0 to 100.0
|
NA milligrams
Full Range 0
No data reported for this subgroup at this time point.
|
NA milligrams
Full Range 0
No data reported for this subgroup at this time point.
|
100.0 milligrams
Full Range 0 • Interval 100.0 to 100.0
|
|
Dosage Per Administration
V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0)
|
100.0 milligrams
Full Range 122 • Interval 90.0 to 123.0
|
100.0 milligrams
Full Range 17.3 • Interval 100.0 to 130.0
|
101.0 milligrams
Full Range 8.5 • Interval 95.0 to 107.0
|
NA milligrams
Full Range 0
No data reported for this subgroup at this time point.
|
100.0 milligrams
Full Range 12.5 • Interval 90.0 to 130.0
|
SECONDARY outcome
Timeframe: One RSV season (5 months)Population: The analysis included participants who were administered palivizumab and had data available for the study visits listed.
The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.
Outcome measures
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
|
|---|---|---|---|---|---|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V1 VAS (S1 n=37; S2 n=43; S3 n=22; NS n=4)
|
50.2 units on a scale
Standard Deviation 22.3
|
64.1 units on a scale
Standard Deviation 19.5
|
53.5 units on a scale
Standard Deviation 25.7
|
62.5 units on a scale
Standard Deviation 9.6
|
57.0 units on a scale
Standard Deviation 22.3
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V1 MBPS (S1 n=37; S2 n=43; S3 n=29; NS n=4)
|
7.2 units on a scale
Standard Deviation 1.7
|
7.5 units on a scale
Standard Deviation 1.5
|
6.9 units on a scale
Standard Deviation 1.8
|
7.8 units on a scale
Standard Deviation 1.5
|
7.2 units on a scale
Standard Deviation 1.7
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V2 VAS (S1 n=33; S2 n=42; S3 n=25; NS n=0)
|
55.3 units on a scale
Standard Deviation 23.4
|
65.6 units on a scale
Standard Deviation 18.2
|
57.2 units on a scale
Standard Deviation 27.3
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
60.1 units on a scale
Standard Deviation 22.7
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V4 MBPS (S1 n=20; S2 n=28; S3 n=22; NS n=0)
|
8.2 units on a scale
Standard Deviation 1.2
|
7.7 units on a scale
Standard Deviation 1.4
|
7.4 units on a scale
Standard Deviation 1.3
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
7.7 units on a scale
Standard Deviation 1.3
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V5 VAS (S1 n=15; S2 n=13; S3 n=14; NS n=0)
|
55.1 units on a scale
Standard Deviation 28.1
|
65.8 units on a scale
Standard Deviation 13.2
|
64.4 units on a scale
Standard Deviation 27.4
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
61.5 units on a scale
Standard Deviation 24.1
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V6 VAS (S1 n=5; S2 n=3; S3 n=4; NS n=0)
|
51.2 units on a scale
Standard Deviation 31.2
|
78.3 units on a scale
Standard Deviation 2.9
|
72.0 units on a scale
Standard Deviation 34.3
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
64.9 units on a scale
Standard Deviation 28.8
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V7 MBPS (S1 n=2; S2 n=3; S3 n=0; NS n=0)
|
4.0 units on a scale
Standard Deviation 1.4
|
6.7 units on a scale
Standard Deviation 1.2
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
5.6 units on a scale
Standard Deviation 1.8
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V2 MBPS (S1 n=34; S2 n=42; S3 n=31; NS n=0)
|
7.2 units on a scale
Standard Deviation 1.6
|
7.9 units on a scale
Standard Deviation 1.5
|
7.3 units on a scale
Standard Deviation 1.9
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
7.5 units on a scale
Standard Deviation 1.6
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V3 VAS (S1 n=31; S2 n=41; S3 n=20; NS n=0)
|
55.9 units on a scale
Standard Deviation 23.6
|
67.8 units on a scale
Standard Deviation 16.4
|
60.0 units on a scale
Standard Deviation 26.6
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
62.1 units on a scale
Standard Deviation 21.9
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V3 MBPS (S1 n=31; S2 n=41; S3 n=24; NS n=0)
|
7.3 units on a scale
Standard Deviation 1.5
|
7.9 units on a scale
Standard Deviation 1.3
|
7.6 units on a scale
Standard Deviation 1.8
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
7.7 units on a scale
Standard Deviation 1.5
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V4 VAS (S1 n=20; S2 n=28; S3 n=19; NS n=0)
|
60.3 units on a scale
Standard Deviation 24.5
|
66.3 units on a scale
Standard Deviation 17.1
|
62.7 units on a scale
Standard Deviation 23.5
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
63.5 units on a scale
Standard Deviation 21.2
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V5 MBPS (S1 n=15; S2 n=13; S3 n=16; NS n=0)
|
6.9 units on a scale
Standard Deviation 2.1
|
7.2 units on a scale
Standard Deviation 1.4
|
8.2 units on a scale
Standard Deviation 1.5
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
7.5 units on a scale
Standard Deviation 1.8
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V6 MBPS (S1 n=5; S2 n=3; S3 n=4; NS n=0)
|
7.4 units on a scale
Standard Deviation 2.2
|
7.3 units on a scale
Standard Deviation 0.6
|
8.8 units on a scale
Standard Deviation 1.9
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
7.8 units on a scale
Standard Deviation 1.8
|
|
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
V7 VAS (S1 n=2; S2 n=3; S3 n=0; NS n=0)
|
30.0 units on a scale
Standard Deviation 0.0
|
73.3 units on a scale
Standard Deviation 11.5
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
NA units on a scale
Standard Deviation NA
No data reported for this subgroup at this time point.
|
56.0 units on a scale
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: One RSV season (5 months)Population: The analysis included parents of participants who were administered and had data available for the study visits listed.
An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit \[ET\]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have "good RSV awareness" if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly.
Outcome measures
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
|
|---|---|---|---|---|---|
|
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
Good RSV Awareness V1 (S1=39;S2=42;S3=32;NS=4)
|
39 Parents of participants
|
36 Parents of participants
|
31 Parents of participants
|
4 Parents of participants
|
110 Parents of participants
|
|
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
Good RSV Awareness LSV (S1=28;S2=32;S3=29;NS=4)
|
28 Parents of participants
|
32 Parents of participants
|
29 Parents of participants
|
4 Parents of participants
|
93 Parents of participants
|
|
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
Good RSV Awareness ET (S1=7;S2=8;S3=3;NS=0)
|
7 Parents of participants
|
7 Parents of participants
|
3 Parents of participants
|
0 Parents of participants
|
17 Parents of participants
|
SECONDARY outcome
Timeframe: One RSV season (5 months), end of studyPopulation: The analysis included participants who were administered palivizumab and had data available for the study visits listed. A total of 100 participants were rated at the last study visit; 2 did not have ratings. A total of 18 participants who discontinued from the study were rated at the early termination visit.
The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.
Outcome measures
| Measure |
RSV Season 1
n=39 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
|
RSV Season 2
n=45 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
|
RSV Season 3
n=32 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
|
No Matching RSV Season
n=4 Participants
Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
|
Total
n=120 Participants
Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
|
|---|---|---|---|---|---|
|
Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
Rating at LSV (S1 n=30;S2 n=36;S3 n=27;NS n=4)
|
9.9 units on a scale
Standard Deviation 0.4
|
9.8 units on a scale
Standard Deviation 0.6
|
9.9 units on a scale
Standard Deviation 0.5
|
10.0 units on a scale
Standard Deviation 0.0
|
9.9 units on a scale
Standard Deviation 0.5
|
|
Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
Rating at ET visit (S1 n=7;S2 n=8;S3 n=3;NS n=0)
|
10.0 units on a scale
Standard Deviation 0.0
|
9.5 units on a scale
Standard Deviation 0.9
|
10.0 units on a scale
Standard Deviation 0.0
|
NA units on a scale
Standard Deviation NA
No participants in this subgroup were rated at an early termination visit.
|
9.8 units on a scale
Standard Deviation 0.6
|
Adverse Events
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
n=120 participants at risk
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
|
|---|---|
|
Infections and infestations
Pneumonia
|
1.7%
2/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Bronchitis
|
0.83%
1/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.83%
1/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Surgical and medical procedures
Hospitalisation
|
0.83%
1/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
Other adverse events
| Measure |
Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab
n=120 participants at risk
Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.7%
2/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.7%
2/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Bronchitis
|
3.3%
4/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Rhinitis
|
2.5%
3/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Varicella
|
2.5%
3/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Bronchitis viral
|
1.7%
2/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
2/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Respiratory tract infection
|
1.7%
2/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/120 • Adverse events were reported from the time informed consent was given until 90 days after the last dose of palivizumab. The average time from first to last study visit was approximately 125 days, with an average therapy duration of approximately 93 days.
|
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER