Surveillance of Synagis in Korean Pediatric Patients
Study Details
Study Description
Brief Summary
Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pediatric Participants at High Risk of RSV Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study. |
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) [From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis]
An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:
-
Preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
-
Newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months preceding RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
-
Newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (CHD).
-
Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.
Exclusion Criteria:
- Contraindications according to the approved label.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: SoRa Lee, MD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P13-203
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 618 participants were enrolled; 1 participant was a duplicate enrollment and the duplicate data was excluded from the analysis. |
| Arm/Group Title | Pediatric Participants at High Risk of RSV |
|---|---|
| Arm/Group Description | Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study. |
| Period Title: Overall Study | |
| STARTED | 617 |
| COMPLETED | 463 |
| NOT COMPLETED | 154 |
Baseline Characteristics
| Arm/Group Title | Pediatric Participants at High Risk of RSV |
|---|---|
| Arm/Group Description | Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study. |
| Overall Participants | 617 |
| Age (months) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [months] |
3.38
(3.39)
|
| Age, Customized (participants) [Number] | |
| Newborn infants (0 to 27 days) |
166
26.9%
|
| Infants and toddlers (28 days to 23 months) |
451
73.1%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
281
45.5%
|
| Male |
336
54.5%
|
Outcome Measures
| Title | Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) |
|---|---|
| Description | An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled. |
| Time Frame | From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pediatric Participants at High Risk of RSV |
|---|---|
| Arm/Group Description | Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study. |
| Measure Participants | 617 |
| Any AE |
126
20.4%
|
| Any ADR |
3
0.5%
|
| Any SAE |
46
7.5%
|
| Any serious ADR |
3
0.5%
|
| Any unexpected AE |
67
10.9%
|
| Any unexpected ADR |
0
0%
|
Adverse Events
| Time Frame | From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Pediatric Participants at High Risk of RSV | |
| Arm/Group Description | Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study. | |
All Cause Mortality |
||
| Pediatric Participants at High Risk of RSV | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Pediatric Participants at High Risk of RSV | ||
| Affected / at Risk (%) | # Events | |
| Total | 46/617 (7.5%) | |
| Cardiac disorders | ||
| Cardiac failure | 2/617 (0.3%) | |
| Arrhythmia | 1/617 (0.2%) | |
| Cyanosis | 1/617 (0.2%) | |
| Eye disorders | ||
| Retinopathy of prematurity | 2/617 (0.3%) | |
| General disorders | ||
| Pyrexia | 4/617 (0.6%) | |
| Condition aggravated | 3/617 (0.5%) | |
| Death | 1/617 (0.2%) | |
| Infections and infestations | ||
| Respiratory syncytial virus infection | 11/617 (1.8%) | |
| Bronchiolitis | 6/617 (1%) | |
| Pneumonia | 4/617 (0.6%) | |
| Rhinovirus infection | 2/617 (0.3%) | |
| Gastroenteritis | 2/617 (0.3%) | |
| Influenza | 2/617 (0.3%) | |
| Pneumonia adenoviral | 1/617 (0.2%) | |
| Adenovirus infection | 1/617 (0.2%) | |
| Bacteraemia | 1/617 (0.2%) | |
| Bronchitis | 1/617 (0.2%) | |
| H1N1 influenza | 1/617 (0.2%) | |
| Parainfluenzae virus infection | 1/617 (0.2%) | |
| Upper respiratory tract infection | 1/617 (0.2%) | |
| Urinary tract infection bacterial | 1/617 (0.2%) | |
| Metabolism and nutrition disorders | ||
| Hyponatraemia | 1/617 (0.2%) | |
| Feeding disorder neonatal | 1/617 (0.2%) | |
| Nervous system disorders | ||
| Clonic convulsion | 1/617 (0.2%) | |
| Convulsion | 1/617 (0.2%) | |
| Hydrocephalus | 1/617 (0.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic respiratory failure | 2/617 (0.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Pediatric Participants at High Risk of RSV | ||
| Affected / at Risk (%) | # Events | |
| Total | 32/617 (5.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Upper respiratory tract infection | 32/617 (5.2%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Information |
|---|---|
| Organization | AbbVie (prior sponsor, Abbott) |
| Phone | 800-633-9110 |
- P13-203