Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine

A Randomized, Double-blind, Placebo-controlled, Post-marketing Phase III Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults.

As a result of the recent supply shortages in the U.S., as well as an anticipated increase in demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S. under the accelerated approval process; marketing approval most likely will be granted before the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a single dose of Fluarix in preventing influenza in adults during the 2005/2006 Influenza season.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 6213
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Hradec Kralove, Czech Republic, 500 03
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female age between, and including, 18 and 64 years of age at the time of the vaccination.
• Written informed consent obtained from the subject.
• Availability to follow up by phone during the study period.
• Female subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

• History of hypersensitivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate.
• Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C).
• Pregnancy
• Chronic disorders of the pulmonary or cardiovascular system, including asthma
• History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of culture confirmed influenza A and/or B during the surveillance period

Secondary Outcome Measures

Outcome Measure
Efficacy: Incidence of ILI, Number of days of fever, days of school/work absenteeism, hospitalization related to influenza illness, Incidence of pneumonia, Incidence of PCR confirmed influenza A and/or B

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Beran J, Wertzova V, Honegr K, Kaliskova E, Havlickova M, Havlik J, Jirincova H, Van Belle P, Jain V, Innis B, Devaster JM. Challenge of conducting a placebo-controlled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: a concrete example. BMC Infect Dis. 2009 Jan 17;9:2. doi: 10.1186/1471-2334-9-2.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: September 15, 2005
• First Submitted That Met QC Criteria: September 15, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 104438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 104438
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 104438
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 104438
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 104438
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 104438
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: 104438
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: 104438
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register