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

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