Trials / Completed
CompletedNCT01037829
Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study
A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,529 (actual)
- Sponsor
- Novartis Vaccines · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| OTHER | Non-intervention observational study | Non-intervention observational study |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2009-12-23
- Last updated
- 2011-09-29
Locations
17 sites across 3 countries: Argentina, Italy, Netherlands
Source: ClinicalTrials.gov record NCT01037829. Inclusion in this directory is not an endorsement.