Flucelvax (TIVc or QIVc) Pregnancy Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Influenza, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/3/2019 |
| Start Date: | September 1, 2017 |
| End Date: | August 31, 2020 |
| Contact: | Clinical Study Disclosure Manager |
| Email: | Seqirus.Clinicaltrials@Seqirus.com |
| Phone: | Use Email |
A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or Quadrivalent (QIVc) Vaccine During Pregnancy
The study is a population based prospective cohort study designed to collect data on
pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine
during pregnancy.
pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine
during pregnancy.
Inclusion Criteria -
Enrollment and data collection will be coordinated through a coordination center (CC). The
minimum eligibility criteria required for enrollment are as follows:
- Sufficient information to confirm that the exposure of interest occurred during
pregnancy and at which date.
- Sufficient information to determine whether it concerns a prospectively enrolled
subject, since retrospective cases are ineligible for enrollment.
- Reporter (e.g. HCP) contact information to allow for follow-up
Exclusion Criteria:
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