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

NCT ID: NCT02282982

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 359 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-05-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infants at high-risk of serious RSV illness

Infants who received immunoprophylaxis during the RSV season

No interventions assigned to this group

Eligibility Criteria

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)

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Strugovschikov, MD

Role: STUDY_DIRECTOR

AbbVie

Related Links

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

Other Identifiers

P14-579

Identifier Type: -

Identifier Source: org_study_id