NCT02282982

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

Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 359 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Respiratory Syncytial Virus (RSV)

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-11-05
• Last updated: 2016-07-29
• Results posted: 2016-06-28