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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01037829 |
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Date of registration:
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21/12/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study
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Scientific title:
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A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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4529 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01037829 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Italy
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Netherlands
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Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Other: Non-intervention observational study
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Primary Outcome(s)
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Congenital malformations
[Time Frame: 3 months follow-up on all live births]
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Normal live-born delivery
[Time Frame: 3 months follow-up on all live births]
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Low birth weight
[Time Frame: 3 months follow-up on all live births]
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Pre-term birth (prematurity)
[Time Frame: 3 months follow-up on all live births]
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Spontaneous and elective abortions
[Time Frame: 3 months follow-up on all live births]
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Neonatal mortality
[Time Frame: 3 months follow-up on all live births]
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Secondary Outcome(s)
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Maternal complications of gestational diabetes, preeclampsia, maternal death
[Time Frame: During pregnancy and post delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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