The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with Afluria during pregnancy.
Study Type
OBSERVATIONAL
Enrollment
490
Afluria is a seasonal influenza vaccine Vaccine exposure in routine care (no vaccination per protocol)
Syneos Health
Wilmington, North Carolina, United States
Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy.
Pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases with events of major congenital malformations among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy.
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases of events of preterm birth among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy.
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Safety Objective: Number of cases of events of low birth weight among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy.
Time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
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