Respiratory Syncytial Virus Infection
Conditions
Keywords
Postmarketing Drug Surveillance
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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Pre-assignment details
A total of 618 participants were enrolled; 1 participant was a duplicate enrollment and the duplicate data was excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Participants at High Risk of RSV 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. | 617 |
| Total | 617 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | No Further Visits to the Clinic | 37 |
| Overall Study | Other | 111 |
| Overall Study | RSV infection | 2 |
Baseline characteristics
| Characteristic | Pediatric Participants at High Risk of RSV |
|---|---|
| Age, Continuous | 3.38 months STANDARD_DEVIATION 3.39 |
| Age, Customized Infants and toddlers (28 days to 23 months) | 451 participants |
| Age, Customized Newborn infants (0 to 27 days) | 166 participants |
| Sex: Female, Male Female | 281 Participants |
| Sex: Female, Male Male | 336 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 617 |
| serious Total, serious adverse events | 46 / 617 |
Outcome results
Primary
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pediatric Participants at High Risk of RSV | Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) | Any AE | 126 participants |
| Pediatric Participants at High Risk of RSV | Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) | Any ADR | 3 participants |
| Pediatric Participants at High Risk of RSV | Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) | Any SAE | 46 participants |
| Pediatric Participants at High Risk of RSV | Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) | Any serious ADR | 3 participants |
| Pediatric Participants at High Risk of RSV | Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) | Any unexpected AE | 67 participants |
| Pediatric Participants at High Risk of RSV | Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) | Any unexpected ADR | 0 participants |