We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037829
First Posted: December 23, 2009
Last Update Posted: September 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
December 21, 2009
December 23, 2009
September 29, 2011
January 2010
November 2010   (Final data collection date for primary outcome measure)
  • Normal live-born delivery [ Time Frame: 3 months follow-up on all live births ]
  • Spontaneous and elective abortions [ Time Frame: 3 months follow-up on all live births ]
  • Congenital malformations [ Time Frame: 3 months follow-up on all live births ]
  • Pre-term birth (prematurity) [ Time Frame: 3 months follow-up on all live births ]
  • Low birth weight [ Time Frame: 3 months follow-up on all live births ]
  • Neonatal mortality [ Time Frame: 3 months follow-up on all live births ]
Same as current
Complete list of historical versions of study NCT01037829 on ClinicalTrials.gov Archive Site
Maternal complications of gestational diabetes, preeclampsia, maternal death [ Time Frame: During pregnancy and post delivery ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Pregnant women
Influenza
Other: Non-intervention observational study
Non-intervention observational study
Pregnancy women
Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women.
Intervention: Other: Non-intervention observational study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4529
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina,   Italy,   Netherlands
 
 
NCT01037829
V111_12
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Not Provided
Novartis
September 2011