Overview

A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus

Status:
Completed
Trial end date:
2017-07-13
Target enrollment:
0
Participant gender:
All
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]).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
Palivizumab
Criteria
Inclusion Criteria:

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 enrollment

- Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary
dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36
weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators,
corticosteroids, etc.) anytime within 6 months prior to enrollment

- Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either
cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic
cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the
pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage
hemodynamically significant CHD

Exclusion Criteria (main exclusion criteria):

- Hospitalization at the time of enrollment (unless discharge is anticipated within 14
days)

- Mechanical ventilation (including continuous positive airway pressure, CPAP) at the
time of enrollment

- Life expectancy less than 6 months

- Unstable cardiac or respiratory status, including cardiac defects so severe that
survival is not expected or for which cardiac transplantation is planned or
anticipated

- Active respiratory illness, or other acute infection