Safety of the new H1N1 influenza vaccine in pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00000318

Enrollment

10000

Registered

2010-03-12

Start date

2009-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

new influenza A(H1N1), spontaneous abortion, preeclampsia, preterm birth, intrauterine growth restriction, congenital disorders

Interventions

Group 1: Pregnant woman vaccinated with the new A(H1N1) influenza vaccine during or just before pregnancy Group 2: Control: Pregnant women without vaccination or other suspicious medication during pre

Eligibility

Sex/Gender

Female

Age

14 Years to 50 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Other suspicious drugs during pregnancy or just before

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Influence of the time of vaccination on the primary outcome	—

Countries

Germany

Contacts

Public ContactChristof Schaefer

Facharzt für Kinderheilkunde und Jugendmedizin, Leiter des Pharmakovigilanz- und Beratungszentrums für Embryonaltoxikologie (BBGes)

schaefer@embryotox.de+49 3030308119

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026