Health Condition 1: J121- Respiratory syncytial virus pneumonia
Conditions
Interventions
Intervention1: Palivizumab (Synagis ): Palivizumab (Synagis ) is administered as a 15 mg/kg intramuscular injection every month for up to 5 doses in infants and children under 24 months of age who are
Sponsors
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Infants born greater than equal to 35 wGA and are less than 6 months of age at enrolment Children less than 24 months of age at enrolment and requiring treatment for BPD within the last 6 months Children less than 24 months of age and with haemodynamically significant CHD
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Hospitalisation at the time of enrolment unless the discharge is expected within 30 days of the time of enrolment Required mechanical ventilation including continuous positive airway pressure or other mechanical respiratory or cardiac support at the time of enrolment Anticipated cardiac surgery within 2 weeks after enrolment Anticipated survival of greater than 6 months after enrolment in the trial Active LRTD including RSV infection at the time of enrolment and or study intervention administration Any fever greater than or equal to 38 degree Celsius or acute illness within 7 days prior to investigational product administration Known history of evolving or unstable neurologic disorder Known history of unstable cardiac or respiratory status including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated Known allergy including to immunoglobulin products or history of allergic reaction Prior or Concurrent Clinical Study Experience Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine including maternal RSV vaccination Receipt of any monoclonal or polyclonal antibody for example hepatitis B immune globulin intravenous immunoglobulin or anticipated use during the study Concurrent enrolment in another interventional study Other Exclusions Children of employees of the sponsor clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals Judgment by the investigator that the participant should not participate in the study if the participant or the participants parent or legal guardian is unlikely to comply with study procedures restrictions and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To asses the Safety of palivizumab by the estimation of occurrence of all AEs and SAEsTimepoint: Day 1 Visit 1 day 31 Visit 2 day 61 Visit 3 day 91 visit 4 day 121 visit 5 day 151 visit 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactMr V V Niranjan Kumar
AstraZeneca Pharma India Ltd
Outcome results
None listed