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Oseltamivir Infant Influenza Safety Study

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza, Human

Phase: N/A

Status: Completed

Sponsored by: Charite University, Berlin, Germany

Official(s) and/or principal investigator(s):
Barbara Rath, MD, Principal Investigator, Affiliation: Charite University Berlin, Department of Pediatrics (Div. of Pneumonology and Immunology)


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.

Clinical Details

Official title: A Prospective, Observational Safety Study in Children <= 24 Months of Age Receiving Oseltamivir for the Treatment or Prophylaxis of Influenza Infection

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number of subjects with Adverse Events

Number of subjects with Adverse Events

Secondary outcome:

Number of subjects treated with oseltamivir

Number of subjects with drug-resistant virus

Detailed description: This study is a prospective, observational, multicenter short-term safety study of the use of oseltamivir (prophylaxis or treatment) in children 24 months of age or younger. An internal comparator group of children diagnosed with influenza and not treated with antiviral medications will be enrolled. The study includes a 30-day follow-up period and will be conducted in multiple sites in multiple countries within the European Union. The

study will cover two consecutive influenza seasons: 01 October 2009 - 31 May 2010 and 01

October 2010 - 31 May 2011. Data collection may be interrupted in the interim period

between influenza seasons (June 1, 2010 - September 30, 2010), depending on whether the

influenza season follows the expected cycle.


Minimum age: N/A. Maximum age: 24 Months. Gender(s): Both.


Inclusion Criteria:

- 24 months of age or younger at time of enrollment

- Diagnosis of influenza A or B (suspected* or confirmed by viral testing) either

treated with oseltamivir or with no antivirals OR prescribed oseltamivir for post-exposure influenza prophylaxis

- Parent/legal guardian willing to provide informed consent and be contacted by

telephone as part of follow-up Exclusion Criteria:

- Patients will be excluded if treated with an influenza antiviral other than

oseltamivir, including amantadine, rimantadine, or zanamivir.

- Suspected influenza is defined as an acute febrile illness characterized by the

presence of fever and 1 or more of the following symptoms: cough, coryza/nasal congestion or sore throat.

Locations and Contacts

Charite University Berlin, Berlin, Germany
Additional Information

Related publications:

Centers for Disease Control and Prevention (CDC). Interim Guidance for Clinicians on the Prevention and Treatment of Novel Influenza A (H1N1) Influenza Virus Infection in Infants and Children. 13 May 2009. Available at http://cdc.gov/h1n1flu/childrentreatment.htm. Accessed 03 Aug 2009.

European Medicines Agency (EMA), Committee for Medicinal Products for Human Use. CHMP ASSESSMENT REPORT on Novel Influenza (H1N1) outbreak Tamiflu (oseltamivir) Relenza (zanamivir) [EMEA/CHMP/287662/2009]. 07 May 2009. Available at http://www.emea.europa.eu/humandocs/PDFs/EPAR/tamiflu/28766209en.pdf. Accessed 28 July 2009.

Food and Drug Administration (FDA). Emergency Use Authorization Letter - Tamiflu. 14 July 2009. Available at http://www.cdc.gov/h1n1flu/eua/pdf/fda_letter_tamiflu.pdf. Accessed 03 Aug 2009.

World Health Organization. 11 Jun 2009. Available at: http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html. Accessed 03 Aug 2009.

Centers for Disease Control and Prevention (CDC). Neurologic complications associated with novel influenza A (H1N1) virus infection in children - Dallas, Texas, May 2009. MMWR Morb Mortal Wkly Rep. 2009 Jul 24;58(28):773-8.

Tamura D, Miura T, Kikuchi Y. Oseltamivir phosphate in infants under 1 year of age with influenza infection. Pediatr Int. 2005 Aug;47(4):484.

Okamoto S, Kamiya I, Kishida K, Shimakawa T, Fukui T, Morimoto T. Experience with oseltamivir for infants younger than 1 year old in Japan. Pediatr Infect Dis J. 2005 Jun;24(6):575-6.

Starting date: December 2009
Last updated: October 13, 2011

Page last updated: August 23, 2015

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