A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women

Novartis Vaccines1 site in 1 country4,529 target enrollmentJanuary 2010

ConditionsInfluenza

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Influenza
Sponsor: Novartis Vaccines
Enrollment: 4529
Locations: 1
Primary Endpoint: Low birth weight
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

November 2010

Last Updated

14 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

Eligibility Criteria

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