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

NCT ID: NCT01037829

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4529 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnancy women

Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women.

Non-intervention observational study

Intervention Type OTHER

Non-intervention observational study

Interventions

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Non-intervention observational study

Non-intervention observational study

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Buenos Aires, , Argentina

Site Status

Córdoba, , Argentina

Site Status

Villa Nueva, , Argentina

Site Status

Bari, , Italy

Site Status

Cagliari, , Italy

Site Status

Como, , Italy

Site Status

Milan, , Italy

Site Status

Milan, , Italy

Site Status

Monza, , Italy

Site Status

Prato, , Italy

Site Status

Roma, , Italy

Site Status

Rome, , Italy

Site Status

Siena, , Italy

Site Status

Trieste, , Italy

Site Status

Udine, , Italy

Site Status

Vicenza, , Italy

Site Status

Podiumweg

Ilsselstein, , Netherlands

Site Status

Countries

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Argentina Italy Netherlands

Other Identifiers

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V111_12

Identifier Type: -

Identifier Source: org_study_id