FluLaval® Quadrivalent Pregnancy Registry

NCT02000466 | Withdrawn

• 1 other identifier: 201086
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza

Keywords

Women; Pregnancy exposure; FluLaval Quadrivalent; Pregnancy outcome; Pregnancy Registry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Exposed cohort

Other: Data collection

Interventions

Data collection OTHER

Initial and follow-up data will be collected using questionnaires

Exposed cohort

Eligibility Criteria

• Age: 12 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, residing in the US, exposed to FluLaval Quadrivalent and who are volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 4, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 27, 2014

Record last verified: 2014-10