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NCT Number: NCT01037829

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-intervention observational study

Other

Non-intervention observational study

Primary outcomes

  1. Normal live-born delivery

    Time frame: 3 months follow-up on all live births

  2. Spontaneous and elective abortions

    Time frame: 3 months follow-up on all live births

  3. Congenital malformations

    Time frame: 3 months follow-up on all live births

  4. Pre-term birth (prematurity)

    Time frame: 3 months follow-up on all live births

  5. Low birth weight

    Time frame: 3 months follow-up on all live births

  6. Neonatal mortality

    Time frame: 3 months follow-up on all live births

Secondary outcomes

  1. Maternal complications of gestational diabetes, preeclampsia, maternal death

    Time frame: During pregnancy and post delivery

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 23, 2009
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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