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

September 28, 2011 updated by: Novartis Vaccines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4529

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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
      • Ilsselstein, Netherlands
        • Podiumweg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normal live-born delivery
Time Frame: 3 months follow-up on all live births
3 months follow-up on all live births
Spontaneous and elective abortions
Time Frame: 3 months follow-up on all live births
3 months follow-up on all live births
Congenital malformations
Time Frame: 3 months follow-up on all live births
3 months follow-up on all live births
Pre-term birth (prematurity)
Time Frame: 3 months follow-up on all live births
3 months follow-up on all live births
Low birth weight
Time Frame: 3 months follow-up on all live births
3 months follow-up on all live births
Neonatal mortality
Time Frame: 3 months follow-up on all live births
3 months follow-up on all live births

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal complications of gestational diabetes, preeclampsia, maternal death
Time Frame: During pregnancy and post delivery
During pregnancy and post delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V111_12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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