Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis (SUNRISE)

AbbVie

Status: Completed

Conditions: Respiratory Syncytial Virus (RSV)

Study type: Observational

Funder types: Industry

Identifiers

NCT02282982

P14-579

Details and patient eligibility

About

This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.

Full description

Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label. The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg. Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.

Enrollment: 359 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study

• Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:

  • Infants born ≤35 weeks gestational age AND are ≤6 months of age at the onset of the RSV season;
  • Infants ≤24 months of age AND with a diagnosis of BPD (defined as oxygen requirement at a corrected gestational age of 36 weeks);
  • Infants ≤24 months of age with hemodynamically significant CHD, unoperated or partially corrected.

• Written authorization to use individual data signed by parents or child representative

Exclusion criteria

• Major congenital malformation aside from CHD
• Chronic pulmonary disease other than BPD
• Acute period of any infection
• Contraindication to palivizumab prescription according to local label
• Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)

Trial design

359 participants in 1 patient group

Infants at high-risk of serious RSV illness

Description:

Infants who received immunoprophylaxis during the RSV season