Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
Up to 2 years
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 ...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT02282982
Start Date
October 1 2014
End Date
May 1 2015
Last Update
July 29 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.