Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study
NCT01037829 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4529
Last updated 2011-09-29
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.
Conditions
Interventions
- OTHER
-
Non-intervention observational study
Non-intervention observational study
Sponsors & Collaborators
-
Novartis Vaccines
lead INDUSTRY
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2010-11-30
- Completion
- 2010-11-30
Countries
- Argentina
- Italy
- Netherlands
Study Locations
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