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NCT01037829 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01037829
Other study ID # V111_12
Secondary ID
Status Completed
Phase N/A
First received December 21, 2009
Last updated September 28, 2011
Start date January 2010
Est. completion date November 2010

Study information
Verified date September 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority The Netherlands: CGR - Code Publieksreclame voor Geneesmiddelen
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4529
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Non-intervention observational study
Non-intervention observational study

Locations
Country Name City State
Netherlands Podiumweg Ilsselstein

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Argentina,  Italy,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Normal live-born delivery 3 months follow-up on all live births Yes
Primary Spontaneous and elective abortions 3 months follow-up on all live births Yes
Primary Congenital malformations 3 months follow-up on all live births Yes
Primary Pre-term birth (prematurity) 3 months follow-up on all live births Yes
Primary Low birth weight 3 months follow-up on all live births Yes
Primary Neonatal mortality 3 months follow-up on all live births Yes
Secondary Maternal complications of gestational diabetes, preeclampsia, maternal death During pregnancy and post delivery Yes
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