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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01037829
First received: December 21, 2009
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Influenza
 Other: Non-intervention observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Flu
Drug Information available for: Lactitol
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Normal live-born delivery [ Time Frame: 3 months follow-up on all live births ] [ Designated as safety issue: Yes ]
  • Spontaneous and elective abortions [ Time Frame: 3 months follow-up on all live births ] [ Designated as safety issue: Yes ]
  • Congenital malformations [ Time Frame: 3 months follow-up on all live births ] [ Designated as safety issue: Yes ]
  • Pre-term birth (prematurity) [ Time Frame: 3 months follow-up on all live births ] [ Designated as safety issue: Yes ]
  • Low birth weight [ Time Frame: 3 months follow-up on all live births ] [ Designated as safety issue: Yes ]
  • Neonatal mortality [ Time Frame: 3 months follow-up on all live births ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal complications of gestational diabetes, preeclampsia, maternal death [ Time Frame: During pregnancy and post delivery ] [ Designated as safety issue: Yes ]

Enrollment: 4529
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnancy women
Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women.
 Other: Non-intervention observational study
Non-intervention observational study

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037829

Locations
Argentina
Buenos Aires, Argentina, 1706
Cordoba, Argentina, X5000
Villa Nueva de Guaymallen, Argentina, 5519
Italy
Bari, Italy, 79124
Cagliari, Italy, 09126
Como, Italy, 22100
Milano, Italy, 20157
Milano, Italy, 20126
Monza, Italy, 20052
Prato, Italy, 59100
Roma, Italy, 00135
Rome, Italy, 00168
Siena, Italy, 53100
Trieste, Italy, 34100
Udine, Italy, 33100
Vicenza, Italy, 36100
Netherlands
Podiumweg
Ilsselstein, Netherlands
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01037829     History of Changes
Other Study ID Numbers: V111_12
Study First Received: December 21, 2009
Last Updated: September 28, 2011
Health Authority: The Netherlands: CGR - Code Publieksreclame voor Geneesmiddelen

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013