Influenza
Conditions
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.
Interventions
Non-intervention observational study
Sponsors
Novartis Vaccines
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Congenital malformations | 3 months follow-up on all live births |
| Normal live-born delivery | 3 months follow-up on all live births |
| Spontaneous and elective abortions | 3 months follow-up on all live births |
| Neonatal mortality | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Maternal complications of gestational diabetes, preeclampsia, maternal death | During pregnancy and post delivery |
Countries
Argentina, Italy, Netherlands
Outcome results
None listed