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Oseltamivir Infant Influenza Safety Study

NCT01286142 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2011-10-17

No results posted yet for this study

Summary

In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A (H1N1). Although little is known about the pandemic influenza strain in children, during previous pandemics and influenza seasons children less than one year of age were shown to be at higher risk of influenza complications than older children. In light of the 2009 H1N1 pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use in infants will dramatically increase due to the new authorizations for use in this population and high prevalence of H1N1 influenza circulating in the population. Ongoing safety surveillance is critical and this study will provide further data for evaluating the risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of both seasonal and pandemic influenza viruses circulating in the population. The study will also provide useful information on the dose and duration of treatment used in clinical practice and their relationship to adverse events.

Conditions

  • Influenza, Human

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Barbara Rath, MD · Charite University Berlin, Department of Pediatrics (Div. of Pneumonology and Immunology)

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-07-31
Completion
2011-09-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286142 on ClinicalTrials.gov