Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study

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Novartis

Status

Completed

Conditions

Influenza

Treatments

Other: Non-intervention observational study

Study type

Observational

Funder types

Industry

Identifiers

NCT01037829
V111_12

Details and patient eligibility

About

The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.

Enrollment

4,529 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome
  • Consents to participate in the study

Exclusion criteria

  • Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest
  • Does not consent to participate in the study
  • Has received a non-Novartis pandemic influenza vaccinee

Trial design

4,529 participants in 1 patient group

Pregnancy women
Description:
Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women.
Treatment:
Other: Non-intervention observational study

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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