Surveillance of Synagis in Korean Pediatric Patients

AbbVie

Status: Completed

Conditions: Respiratory Syncytial Virus Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01537198

P13-203

Details and patient eligibility

About

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.

Enrollment: 618 patients

Sex: All

Ages: 1 day to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

618 participants in 1 patient group

Pediatric Participants at High Risk of RSV

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.