Premature Infants
Conditions
Keywords
Premature infants, Respiratory Syncytial Virus (RSV), Compliance, Palivizumab
Brief summary
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such as parents' knowledge of burden of respiratory syncytial virus disease or physicians' satisfaction with Synagis as well as the appropriate use of the product might influence compliance. The primary objective of this observational study is to evaluate the compliance to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against severe respiratory syncytial virus disease, was administered according to usual clinical practice. Compliance was assessed using four criteria: The number of injections per participant per respiratory syncytial virus season, the body site where injections were administered, the interval in days between injections, and the dosage per administration. Originally the study was to include two respiratory syncytial virus seasons but was extended to a third season.
Interventions
None listed
Sponsors
Assign Data Management and Biostatistics GmbH
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* Premature infant 33 to 35 weeks gestational age * Younger than 3 months at respiratory syncytial virus season start * At least 4 points according to the Austrian risk score according to Austrian guidelines: 1 point younger than 3 months (at start of respiratory syncytial virus season), 1 point neurologic disease, 1 point weight less than 10th percentile, 1 point discharge from hospital during respiratory syncytial virus season (1 Oct - 30 March), 1 point older siblings, 0.5 points multiple births, 0.5 points day care attendance, 0.5 points passive tobacco smoke exposure, 0.5 points socio-economic status (overcrowding) * Synagis application (prescription) * Signed authorization form for data use (parental authorization)
Exclusion criteria
* Patients without Synagis prescription * Patients who meet contraindications as outlined in the latest version of Synagis summary of product characteristics (SmPC): * Patients with known hypersensitivity to palivizumab or any component of the formulation or other humanized monoclonal antibodies * Patients with chronic lung disease * Patients with congenital heart disease * Greater than 36 weeks gestational age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Injections Per Patient Per Season | One RSV season (5 months) | The average number of injections administered per participant within a respiratory syncytial virus season. |
| Body Site of Injections Per Administration | One RSV season (5 months) | The body site of injection administration for participants at each study visit. |
| Interval Between Administrations | One RSV season (5 months) | The average number of days that elapsed between palivizumab injections administered at the previous study visit. |
| Dosage Per Administration | One RSV season (5 months) | The median dose and range of palivizumab (milligrams) that was administered at each study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parents Knowledge of Burden of RSV Disease Via Interview by Physician | One RSV season (5 months) | 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. |
| Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale | One RSV season (5 months), end of study | 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. |
| Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale) | One RSV season (5 months) | 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. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RSV Season 1 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) | 39 |
| RSV Season 2 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) | 45 |
| RSV Season 3 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) | 32 |
| No Matching RSV Season Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3 | 4 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Changed doctors | 2 |
| Overall Study | End of RSV season nearly reached | 1 |
| Overall Study | Mother unconvinced of the necessity | 1 |
| Overall Study | Noncompliance | 2 |
| Overall Study | Parental desire | 8 |
| Overall Study | Parents thought too many injections | 2 |
| Overall Study | Quota used up (insurance reimb issue) | 2 |
| Overall Study | Screen failure, did not take palivizumab | 4 |
Baseline characteristics
| Characteristic | No Matching RSV Season | RSV Season 1 | RSV Season 2 | RSV Season 3 | Total |
|---|---|---|---|---|---|
| Age, Customized 10 months | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Customized 1 month | 0 Participants | 10 Participants | 15 Participants | 7 Participants | 32 Participants |
| Age, Customized 3 months | 0 Participants | 4 Participants | 6 Participants | 4 Participants | 14 Participants |
| Age, Customized 4 to 4.5 months | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Age, Customized 5 months | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 5 Participants |
| Age, Customized 6 months | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Age, Customized 7 months | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized 8 months | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Age, Customized 9 months | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized Age not reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized Greater than 1 and less than or equal to 2 months | 3 Participants | 19 Participants | 12 Participants | 14 Participants | 48 Participants |
| Age, Customized Less than 1 month | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 5 Participants |
| Body weight | 3.5 kilograms STANDARD_DEVIATION 1.1 | 3.9 kilograms STANDARD_DEVIATION 1.4 | 3.8 kilograms STANDARD_DEVIATION 1.5 | 4.1 kilograms STANDARD_DEVIATION 1.6 | 3.9 kilograms STANDARD_DEVIATION 1.5 |
| Gestational age 23 weeks | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Gestational age 28 weeks | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Gestational age 31 weeks | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Gestational age 33 weeks | 1 Participants | 24 Participants | 18 Participants | 14 Participants | 57 Participants |
| Gestational age 34 weeks | 3 Participants | 9 Participants | 18 Participants | 12 Participants | 42 Participants |
| Gestational age 35 weeks | 0 Participants | 6 Participants | 8 Participants | 4 Participants | 18 Participants |
| Sex: Female, Male Female | 3 Participants | 13 Participants | 21 Participants | 13 Participants | 50 Participants |
| Sex: Female, Male Male | 1 Participants | 26 Participants | 24 Participants | 19 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 120 |
| serious Total, serious adverse events | 5 / 120 |
Outcome results
Primary
Body Site of Injections Per Administration
The body site of injection administration for participants at each study visit.
Time frame: One RSV season (5 months)
Population: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV Season 1 | Body Site of Injections Per Administration | Visit 7: Thigh | 2 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 6: Other location | 0 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 5: Thigh | 15 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 3: Thigh | 31 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 2: Thigh | 34 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 1: Thigh | 38 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 6: Thigh | 5 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 4: Other location | 0 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 3: Other location | 0 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 5: Other location | 0 participants |
| RSV Season 1 | Body Site of Injections Per Administration | Visit 4: Thigh | 20 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 7: Thigh | 3 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 1: Thigh | 44 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 5: Thigh | 13 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 4: Other location | 0 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 3: Other location | 0 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 6: Other location | 0 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 2: Thigh | 43 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 4: Thigh | 28 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 6: Thigh | 3 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 3: Thigh | 42 participants |
| RSV Season 2 | Body Site of Injections Per Administration | Visit 5: Other location | 0 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 1: Thigh | 29 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 3: Other location | 1 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 6: Thigh | 3 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 2: Thigh | 32 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 3: Thigh | 23 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 4: Thigh | 22 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 4: Other location | 1 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 5: Thigh | 15 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 5: Other location | 1 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 6: Other location | 1 participants |
| RSV Season 3 | Body Site of Injections Per Administration | Visit 7: Thigh | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 3: Other location | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 5: Thigh | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 5: Other location | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 3: Thigh | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 6: Thigh | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 2: Thigh | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 7: Thigh | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 6: Other location | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 1: Thigh | 4 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 4: Other location | 0 participants |
| No Matching RSV Season | Body Site of Injections Per Administration | Visit 4: Thigh | 0 participants |
| Total | Body Site of Injections Per Administration | Visit 6: Thigh | 11 participants |
| Total | Body Site of Injections Per Administration | Visit 6: Other location | 1 participants |
| Total | Body Site of Injections Per Administration | Visit 5: Thigh | 43 participants |
| Total | Body Site of Injections Per Administration | Visit 3: Other location | 1 participants |
| Total | Body Site of Injections Per Administration | Visit 3: Thigh | 96 participants |
| Total | Body Site of Injections Per Administration | Visit 7: Thigh | 5 participants |
| Total | Body Site of Injections Per Administration | Visit 1: Thigh | 115 participants |
| Total | Body Site of Injections Per Administration | Visit 5: Other location | 1 participants |
| Total | Body Site of Injections Per Administration | Visit 4: Other location | 1 participants |
| Total | Body Site of Injections Per Administration | Visit 2: Thigh | 109 participants |
| Total | Body Site of Injections Per Administration | Visit 4: Thigh | 70 participants |
Primary
Dosage Per Administration
The median dose and range of palivizumab (milligrams) that was administered at each study visit.
Time frame: One RSV season (5 months)
Population: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| RSV Season 1 | Dosage Per Administration | V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0) | 100.0 milligrams | Full Range 122 |
| RSV Season 1 | Dosage Per Administration | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | 100.0 milligrams | Full Range 0 |
| RSV Season 1 | Dosage Per Administration | V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0) | 99.0 milligrams | Full Range 1767.4 |
| RSV Season 1 | Dosage Per Administration | V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0) | 100.0 milligrams | Full Range 7.8 |
| RSV Season 1 | Dosage Per Administration | V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4) | 60.0 milligrams | Full Range 1925.2 |
| RSV Season 1 | Dosage Per Administration | V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0) | 77.5 milligrams | Full Range 1210.7 |
| RSV Season 1 | Dosage Per Administration | V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0) | 85.0 milligrams | Full Range 3077.5 |
| RSV Season 2 | Dosage Per Administration | V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0) | 100.0 milligrams | Full Range 17.3 |
| RSV Season 2 | Dosage Per Administration | V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0) | 100.0 milligrams | Full Range 18.2 |
| RSV Season 2 | Dosage Per Administration | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | 100.0 milligrams | Full Range 0 |
| RSV Season 2 | Dosage Per Administration | V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0) | 80.0 milligrams | Full Range 22.7 |
| RSV Season 2 | Dosage Per Administration | V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0) | 97.5 milligrams | Full Range 285.3 |
| RSV Season 2 | Dosage Per Administration | V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4) | 50.0 milligrams | Full Range 25.8 |
| RSV Season 2 | Dosage Per Administration | V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0) | 70.0 milligrams | Full Range 23.2 |
| RSV Season 3 | Dosage Per Administration | V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0) | 100.0 milligrams | Full Range 20.1 |
| RSV Season 3 | Dosage Per Administration | V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4) | 73.5 milligrams | Full Range 26.2 |
| RSV Season 3 | Dosage Per Administration | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | NA milligrams | Full Range 0 |
| RSV Season 3 | Dosage Per Administration | V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0) | 84.0 milligrams | Full Range 22 |
| RSV Season 3 | Dosage Per Administration | V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0) | 96.0 milligrams | Full Range 21.1 |
| RSV Season 3 | Dosage Per Administration | V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0) | 100.0 milligrams | Full Range 24.1 |
| RSV Season 3 | Dosage Per Administration | V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0) | 101.0 milligrams | Full Range 8.5 |
| No Matching RSV Season | Dosage Per Administration | V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0) | NA milligrams | Full Range 0 |
| No Matching RSV Season | Dosage Per Administration | V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4) | 52.5 milligrams | Full Range 24.2 |
| No Matching RSV Season | Dosage Per Administration | V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0) | NA milligrams | Full Range 0 |
| No Matching RSV Season | Dosage Per Administration | V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0) | NA milligrams | Full Range 0 |
| No Matching RSV Season | Dosage Per Administration | V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0) | NA milligrams | Full Range 0 |
| No Matching RSV Season | Dosage Per Administration | V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0) | NA milligrams | Full Range 0 |
| No Matching RSV Season | Dosage Per Administration | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | NA milligrams | Full Range 0 |
| Total | Dosage Per Administration | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | 100.0 milligrams | Full Range 0 |
| Total | Dosage Per Administration | V6 (S1 n=5; S2 n=3; S3 n=2; NS n=0) | 100.0 milligrams | Full Range 12.5 |
| Total | Dosage Per Administration | V3 (S1 n=29; S2 n=42; S3 n=21; NS n=0) | 85.5 milligrams | Full Range 1795.8 |
| Total | Dosage Per Administration | V1 (S1 n=36; S2 n=44; S3 n=26; NS n=4) | 60.0 milligrams | Full Range 1134.4 |
| Total | Dosage Per Administration | V2 (S1 n=32; S2 n=43; S3 n=27; NS n=0) | 79.5 milligrams | Full Range 686 |
| Total | Dosage Per Administration | V5 (S1 n=15; S2 n=13; S3 n=13; NS n=0) | 100.0 milligrams | — |
| Total | Dosage Per Administration | V4 (S1 n=20; S2 n=28; S3 n=20; NS n=0) | 100.0 milligrams | Full Range 973.1 |
Primary
Interval Between Administrations
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Time frame: One RSV season (5 months)
Population: The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RSV Season 1 | Interval Between Administrations | V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0) | 34.5 Days | Standard Deviation 9.4 |
| RSV Season 1 | Interval Between Administrations | V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0) | 33.2 Days | Standard Deviation 12.4 |
| RSV Season 1 | Interval Between Administrations | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | 34.0 Days | Standard Deviation 0 |
| RSV Season 1 | Interval Between Administrations | V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0) | 33.4 Days | Standard Deviation 13.9 |
| RSV Season 1 | Interval Between Administrations | V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0) | 24.8 Days | Standard Deviation 10.3 |
| RSV Season 1 | Interval Between Administrations | V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0) | 28.5 Days | Standard Deviation 9.1 |
| RSV Season 2 | Interval Between Administrations | V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0) | 32.5 Days | Standard Deviation 12.9 |
| RSV Season 2 | Interval Between Administrations | V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0) | 30.0 Days | Standard Deviation 1.7 |
| RSV Season 2 | Interval Between Administrations | V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0) | 34.7 Days | Standard Deviation 12.1 |
| RSV Season 2 | Interval Between Administrations | V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0) | 30.6 Days | Standard Deviation 9.2 |
| RSV Season 2 | Interval Between Administrations | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | 30.0 Days | Standard Deviation 1.7 |
| RSV Season 2 | Interval Between Administrations | V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0) | 41.8 Days | Standard Deviation 48.2 |
| RSV Season 3 | Interval Between Administrations | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | NA Days | — |
| RSV Season 3 | Interval Between Administrations | V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0) | 28.4 Days | Standard Deviation 5.5 |
| RSV Season 3 | Interval Between Administrations | V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0) | 32.0 Days | Standard Deviation 5.5 |
| RSV Season 3 | Interval Between Administrations | V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0) | 30.3 Days | Standard Deviation 4.8 |
| RSV Season 3 | Interval Between Administrations | V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0) | 29.5 Days | Standard Deviation 1.7 |
| RSV Season 3 | Interval Between Administrations | V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0) | 28.6 Days | Standard Deviation 9.2 |
| No Matching RSV Season | Interval Between Administrations | V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0) | NA Days | — |
| No Matching RSV Season | Interval Between Administrations | V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0) | NA Days | — |
| No Matching RSV Season | Interval Between Administrations | V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0) | NA Days | — |
| No Matching RSV Season | Interval Between Administrations | V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0) | NA Days | — |
| No Matching RSV Season | Interval Between Administrations | V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0) | NA Days | — |
| No Matching RSV Season | Interval Between Administrations | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | NA Days | — |
| Total | Interval Between Administrations | V6 (S1 n=6; S2 n=3; S3 n=4; NS n=0) | 27.5 Days | Standard Deviation 7.2 |
| Total | Interval Between Administrations | V4 (S1 n=20; S2 n=28; S3 n=23; NS n=0) | 36.6 Days | Standard Deviation 30.8 |
| Total | Interval Between Administrations | V3 (S1 n=32; S2 n=42; S3 n=24; NS n=0) | 33.1 Days | Standard Deviation 10.9 |
| Total | Interval Between Administrations | V2 (S1 n=33; S2 n=42; S3 n=29; NS n=0) | 29.4 Days | Standard Deviation 9.1 |
| Total | Interval Between Administrations | V7 (S1 n=2; S2 n=3; S3 n=0; NS n=0) | 31.6 Days | Standard Deviation 2.5 |
| Total | Interval Between Administrations | V5 (S1 n=15; S2 n=13; S3 n=16; NS n=0) | 31.3 Days | Standard Deviation 11.2 |
Primary
Number of Injections Per Patient Per Season
The average number of injections administered per participant within a respiratory syncytial virus season.
Time frame: One RSV season (5 months)
Population: Participants who were administered palivizumab were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RSV Season 1 | Number of Injections Per Patient Per Season | 3.8 Injections administered | Standard Deviation 1.3 |
| RSV Season 2 | Number of Injections Per Patient Per Season | 3.9 Injections administered | Standard Deviation 1.1 |
| RSV Season 3 | Number of Injections Per Patient Per Season | 4.0 Injections administered | Standard Deviation 1.4 |
| No Matching RSV Season | Number of Injections Per Patient Per Season | 1.0 Injections administered | Standard Deviation 0 |
| Total | Number of Injections Per Patient Per Season | 3.8 Injections administered | Standard Deviation 1.3 |
Secondary
Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)
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.
Time frame: One RSV season (5 months)
Population: The analysis included participants who were administered palivizumab and had data available for the study visits listed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 2 | 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) | 7.9 units on a scale | Standard Deviation 1.3 |
| RSV Season 2 | 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) | 65.8 units on a scale | Standard Deviation 13.2 |
| RSV Season 2 | 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) | 7.3 units on a scale | Standard Deviation 0.6 |
| RSV Season 2 | 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) | 67.8 units on a scale | Standard Deviation 16.4 |
| RSV Season 2 | 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) | 66.3 units on a scale | Standard Deviation 17.1 |
| RSV Season 2 | 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) | 7.9 units on a scale | Standard Deviation 1.5 |
| RSV Season 2 | 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) | 7.7 units on a scale | Standard Deviation 1.4 |
| RSV Season 2 | 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) | 6.7 units on a scale | Standard Deviation 1.2 |
| RSV Season 2 | 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) | 7.5 units on a scale | Standard Deviation 1.5 |
| RSV Season 2 | 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) | 78.3 units on a scale | Standard Deviation 2.9 |
| RSV Season 2 | 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) | 73.3 units on a scale | Standard Deviation 11.5 |
| RSV Season 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) | 7.2 units on a scale | Standard Deviation 1.4 |
| RSV Season 2 | 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) | 65.6 units on a scale | Standard Deviation 18.2 |
| RSV Season 2 | 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) | 64.1 units on a scale | Standard Deviation 19.5 |
| RSV Season 3 | 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) | 72.0 units on a scale | Standard Deviation 34.3 |
| RSV Season 3 | 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) | 53.5 units on a scale | Standard Deviation 25.7 |
| RSV Season 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) | 6.9 units on a scale | Standard Deviation 1.8 |
| RSV Season 3 | 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) | 57.2 units on a scale | Standard Deviation 27.3 |
| RSV Season 3 | 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) | 7.3 units on a scale | Standard Deviation 1.9 |
| RSV Season 3 | 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) | 60.0 units on a scale | Standard Deviation 26.6 |
| RSV Season 3 | 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) | 7.6 units on a scale | Standard Deviation 1.8 |
| RSV Season 3 | 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) | 62.7 units on a scale | Standard Deviation 23.5 |
| RSV Season 3 | 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) | 7.4 units on a scale | Standard Deviation 1.3 |
| RSV Season 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) | 64.4 units on a scale | Standard Deviation 27.4 |
| RSV Season 3 | 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) | 8.2 units on a scale | Standard Deviation 1.5 |
| RSV Season 3 | 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) | 8.8 units on a scale | Standard Deviation 1.9 |
| RSV Season 3 | 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) | NA units on a scale | — |
| RSV Season 3 | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | 7.8 units on a scale | Standard Deviation 1.5 |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | 62.5 units on a scale | Standard Deviation 9.6 |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | NA units on a scale | — |
| Total | 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) | 7.7 units on a scale | Standard Deviation 1.5 |
| Total | 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) | 57.0 units on a scale | Standard Deviation 22.3 |
| Total | 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) | 61.5 units on a scale | Standard Deviation 24.1 |
| Total | 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) | 62.1 units on a scale | Standard Deviation 21.9 |
| Total | 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) | 7.5 units on a scale | Standard Deviation 1.8 |
| Total | 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) | 7.5 units on a scale | Standard Deviation 1.6 |
| Total | 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 |
| Total | 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) | 64.9 units on a scale | Standard Deviation 28.8 |
| Total | 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) | 60.1 units on a scale | Standard Deviation 22.7 |
| Total | 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) | 5.6 units on a scale | Standard Deviation 1.8 |
| Total | 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) | 7.8 units on a scale | Standard Deviation 1.8 |
| Total | 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) | 63.5 units on a scale | Standard Deviation 21.2 |
| Total | 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) | 56.0 units on a scale | Standard Deviation 25.1 |
| Total | 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) | 7.7 units on a scale | Standard Deviation 1.3 |
Secondary
Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale
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.
Time frame: One RSV season (5 months), end of study
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 2 | 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) | 9.8 units on a scale | Standard Deviation 0.6 |
| RSV Season 2 | 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) | 9.5 units on a scale | Standard Deviation 0.9 |
| RSV Season 3 | 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 0.5 |
| RSV Season 3 | 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 |
| No Matching RSV Season | 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) | NA units on a scale | — |
| No Matching RSV Season | 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) | 10.0 units on a scale | Standard Deviation 0 |
| Total | 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 0.5 |
| Total | 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) | 9.8 units on a scale | Standard Deviation 0.6 |
Secondary
Parents Knowledge of Burden of RSV Disease Via Interview by Physician
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.
Time frame: One RSV season (5 months)
Population: The analysis included parents of participants who were administered and had data available for the study visits listed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 1 | 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 |
| RSV Season 2 | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness LSV (S1=28;S2=32;S3=29;NS=4) | 32 Parents of participants |
| RSV Season 2 | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness V1 (S1=39;S2=42;S3=32;NS=4) | 36 Parents of participants |
| RSV Season 2 | 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 |
| RSV Season 3 | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness LSV (S1=28;S2=32;S3=29;NS=4) | 29 Parents of participants |
| RSV Season 3 | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness V1 (S1=39;S2=42;S3=32;NS=4) | 31 Parents of participants |
| RSV Season 3 | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness ET (S1=7;S2=8;S3=3;NS=0) | 3 Parents of participants |
| No Matching RSV Season | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness V1 (S1=39;S2=42;S3=32;NS=4) | 4 Parents of participants |
| No Matching RSV Season | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness ET (S1=7;S2=8;S3=3;NS=0) | 0 Parents of participants |
| No Matching RSV Season | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness LSV (S1=28;S2=32;S3=29;NS=4) | 4 Parents of participants |
| Total | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness LSV (S1=28;S2=32;S3=29;NS=4) | 93 Parents of participants |
| Total | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness V1 (S1=39;S2=42;S3=32;NS=4) | 110 Parents of participants |
| Total | Parents Knowledge of Burden of RSV Disease Via Interview by Physician | Good RSV Awareness ET (S1=7;S2=8;S3=3;NS=0) | 17 Parents of participants |