FluLaval® Quadrivalent Pregnancy Registry

Influenza Clinical Trial

Official title:

FluLaval® Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With FluLaval® Quadrivalent During Pregnancy or Within 28 Days Preceding Conception

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02000466
• Other study ID #: 201086
• Status: Withdrawn
• Phase: N/A
• First received: November 27, 2013
• Last updated: October 23, 2014
• Start date: November 2013
• Est. completion date: May 2018

Study information

• Verified date: October 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively.

Description:

Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.

Pregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD from 30 November 2013 to 31 May 2018.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 64 Years

Eligibility

Inclusion Criteria:

A subject will be included in the Registry if all of the following criteria are met:

• Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.

• Subject is a US resident.

• A HCP is identified (name, address and phone number).

• Subject can be identified (by GSK or HCP).

Data from registered subjects will be included in the analyses if the following criterion is met:

• Pregnancy is ongoing and the outcome is unknown.

Exclusion Criteria:

Data from registered subjects will not be included in the analyses if the following criterion is met:

• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza

Intervention

Other:
• Data collection
Initial and follow-up data will be collected using questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception		Up to 12 months after EDD	No