A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

Study Identifier
P10-129
CT.gov Identifier
NCT01297504
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Respiratory Syncytial Virus (RSV)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    N/A - 2 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form. * Parent or legal guardian of child provides written Informed Consent
    Exclusion Criteria:
    * Children excluded from receiving palivizumab as per local guidelines

    Protocol Summary

    The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 52185
    Buenos Aires, Argentina, C1115AAB
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52182
    Buenos Aires, Argentina
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52183
    Buenos Aires, Argentina
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 52184
    Buenos Aires, Argentina
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 54426
    Santiago, Chile
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 54427
    Santiago, Chile
    Status
    Not applicable
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