Clinical trial NCT02968173
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: Bronchopulmonary dysplasia (BPD) RSV hospitalization Palivizumab Immunoprophylaxis Chronic lung disease (CLD) of prematurity
Sponsor: AbbVie
Start date: 2016-11-09; Completion date: 2017-07-13
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease \[CLD\] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease \[CHD\]).

Detailed description:
Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated periods of RSV risk in the community; the number of doses will depend on the time of enrollment during the RSV season.

Arms: arm 1: A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled.
Interventions: intervention 1: Palivizumab
Intervention descriptions: intervention 1: Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.

Protocol documents:
Prot_001.pdf: 
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