FluLaval® Quadrivalent Pregnancy Registry

NCT ID: NCT02000466

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-05-31

Brief 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.

Detailed 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.

Conditions

Influenza

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed cohort

Data collection

Intervention Type: OTHER

Initial and follow-up data will be collected using questionnaires

Interventions

Data collection

Initial and follow-up data will be collected using questionnaires

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

201086

Identifier Type: -

Identifier Source: org_study_id