Pregnant Women, Influenza Clinical Trial
Official title:
Flucelvax Pregnancy Registry: an Observational Study on the Safety of Flucelvax Exposure in Pregnant Women and Their Offspring
| Verified date | October 2017 |
| Source | Seqirus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes. - Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy - Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry) - Date the pregnancy exposure is registered - Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation) Exclusion Criteria: - Invalid registry reports and pregnancies deemed lost to follow-up will be excluded from the primary analysis. Retrospective reports will not be included, although retrospective cases with MCMs will be reviewed and reported separately. |
| Country | Name | City | State |
|---|---|---|---|
| United States | PPD | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Seqirus |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Live birth | From time of enrollment during pregnancy to time of delivery or pregnancy termination | ||
| Other | stillbirth | From time of enrollment during pregnancy to time of delivery or pregnancy termination | ||
| Other | spontaneous abortion | From time of enrollment during pregnancy to time of delivery or pregnancy termination | ||
| Other | ectopic pregnancy | From time of enrollment during pregnancy to time of delivery or pregnancy termination | ||
| Other | molar pregnancy | From time of enrollment during pregnancy to time of delivery or pregnancy termination | ||
| Primary | major congenital malformation | From time of enrollment during pregnancy to time of delivery or pregnancy termination | ||
| Primary | preterm birth | From time of enrollment during pregnancy to time of delivery or pregnancy termination | ||
| Primary | low birth weight | From time of enrollment during pregnancy to time of delivery or pregnancy termination |