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

Completed

• Conditions: Influenza
• Interventions: Other: Non-intervention observational study

• Registration Number: NCT01037829
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2009-12-21
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Study Start: 2010-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4529

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnancy women	Non-intervention observational study	Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maternal complications of gestational diabetes, preeclampsia, maternal death	During pregnancy and post delivery

Trial Locations

Locations (1)

Podiumweg; 🇳🇱 Ilsselstein, Netherlands