Safety of the new H1N1 influenza vaccine in pregnancy
- Conditions
- new influenza A(H1N1), spontaneous abortion, preeclampsia, preterm birth, intrauterine growth restriction, congenital disorders
- Registration Number
- DRKS00000318
- Lead Sponsor
- Paul-Ehrlich-Institut PEIAbteilung Sicherheit von Arzneimitteln und Medizinprodukten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 1652
Inclusion Criteria
1. Live in Germany
2. Vaccinated with new H1N1 vaccine during pregnancy or just before
Exclusion Criteria
Other suspicious drugs during pregnancy or just before
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Influence of the time of vaccination on the primary outcome