Trial document





This trial has been registered retrospectively.
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  DRKS00000318

Trial Description

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Title

Safety of the new H1N1 influenza vaccine in pregnancy

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Trial Acronym

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URL of the Trial

http://www.embryotox.de/aktuelles.html

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Brief Summary in Lay Language

The new H1N1 influenza may pose an increased risk of severe illness in pregnant women, hence the Strategic Advisory Group of Experts on Immunization of the World Health Organization recommends vaccination in pregnant women. In Germany, the vaccine commission of the Robert Koch-Institut recommends that pregnant women be vaccinated preferably from the 2nd trimester and use non-adjuvanted vaccines. However, data on the possible adverse effects of the vaccine on the foetus are sparse. The aim of this study is therefore to evaluate the safety of the new H1N1 vaccine in pregnancy and to evaluate the possible adverse effects on the course of pregnancy or the newborn.

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Brief Summary in Scientific Language

The new H1N1 influenza may pose an increased risk of severe illness in pregnant women, maybe due to the physiological and immunological changes happening during pregnancy. Hence the Strategic Advisory Group of Experts on Immunization of the World Health Organization recommends vaccination in pregnant women. In Germany, the vaccine commission of the Robert Koch-Institut recommends that pregnant women be vaccinated preferably from the 2nd trimester and use non-adjuvanted vaccines. Possible teratogenic effects have only been studied for the seasonal influenza vaccine, and there was no increased risk found so far, though there is not enough data to draw a definitive conclusion. The FDA classifies this vaccine in "Pregnancy category C". There is no safety data on the adjuvanted version of the vaccine. The aim of this prospective cohort study is therefore to evaluate the possible teratogenic effects of the new H1N1 vaccine, both for the non-adjuvanted and the adjuvanted versions of the vaccine.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000318
  •   2010/03/12
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  •   no
  •   Approved
  •   322/09, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   new influenza A(H1N1), spontaneous abortion, preeclampsia, preterm birth, intrauterine growth restriction, congenital disorders
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Interventions/Observational Groups

  •   Pregnant woman vaccinated with the new A(H1N1) influenza vaccine during or just before pregnancy
  •   Control: Pregnant women without vaccination or other suspicious medication during pregnancy
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Other
  •   Parallel
  •   N/A
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Primary Outcome

Possible adverse effects on pregnancy and possible teratogenic effects of the new H1N1 vaccine evaluated in terms of the rate of spontaneous abortion, preeclampsia, preterm birth, intrauterine growth restriction, congenital disorders.

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Secondary Outcome

Influence of the time of vaccination on the primary outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/10/01
  •   10000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   14   Years
  •   50   Years
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Additional Inclusion Criteria

1. Live in Germany
2. Vaccinated with new H1N1 vaccine during pregnancy or just before

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Exclusion Criteria

Other suspicious drugs during pregnancy or just before

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Addresses

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    • Paul-Ehrlich-Institut PEI Abteilung Sicherheit von Arzneimitteln und Medizinprodukten
    • Paul-Ehrlich-Str. 51-59
    • 63225  Langen
    • Germany
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    • Facharzt für Kinderheilkunde und Jugendmedizin Leiter des Pharmakovigilanz- und Beratungszentrums für Embryonaltoxikologie (BBGes)
    • Mr.  Dr. med.  Christof  Schaefer 
    • Spandauer Damm 130, Haus 10
    • 14050  Berlin
    • Germany
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    • Facharzt für Kinderheilkunde und Jugendmedizin, Leiter des Pharmakovigilanz- und Beratungszentrums für Embryonaltoxikologie (BBGes)
    • Mr.  Dr. med.  Christof  Schaefer 
    • Spandauer Damm 130, Haus 10
    • 14050  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • Friedrichstraße 108
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/03/31
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Trial Publications, Results and other Documents

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