Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

January 16, 2017 updated by: GlaxoSmithKline

A Phase III, Observer-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix™ (GlaxoSmithKline Biologicals) Compared With Fluzone® (Aventis Pasteur) Administered Intramuscularly in Adults 18 Years and Older in the U.S.

The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.

Study Overview

Status

Completed

Conditions

Influenza

Intervention / Treatment

Biological: Influenza

Detailed Description

Experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately:
Study vaccine: full dose of Fluarix by IM administration.
Control vaccine: full dose of Fluzone by IM administration.
Two scheduled visits per subject at days 0 (visit 1) and 21(visit 2) with blood sample collected at each visit to evaluate the immune response. There will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion.
Vaccination schedule: one IM injection at day 0.
Type of study: Self contained.

Study Type

Interventional

Enrollment (Actual)

1847

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Clearwater, Florida, United States, 33761
    - GSK Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - GSK Investigational Site
- Missouri
  - St. Louis, Missouri, United States, 63110
    - GSK Investigational Site
- New York
  - Buffalo, New York, United States, 14209
    - GSK Investigational Site
  - Poughkeepsie, New York, United States, 12601
    - GSK Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - GSK Investigational Site
- Pennsylvania
  - Carnegie, Pennsylvania, United States, 15106
    - GSK Investigational Site
  - Erie, Pennsylvania, United States, 16506
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19107
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15236
    - GSK Investigational Site
- Rhode Island
  - Warwick, Rhode Island, United States, 02886
    - GSK Investigational Site
- Texas
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Katy, Texas, United States, 77450
    - GSK Investigational Site
- Wisconsin
  - Marshfield, Wisconsin, United States, 54449
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

All adults 18 years and older.
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study.
Written informed consent obtained from the subject.
If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions .

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
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(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal 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 (99.5°F) / Axillary temperature <37.5°C (99.5°F)).
History of Guillain Barré syndrome within 6 weeks of prior receipt of inactivated influenza virus vaccine.
Pregnancy and lactating females.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)

Secondary Outcome Measures

Outcome Measure
Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs)
Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age
Safety comparison (sol local, general & unsol AEs, SAEs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Campbell JD, Chambers CV, Brady RC, Caldwell MC, Bennett NL, Fourneau MA, Jain VK, Innis BL. Immunologic non-inferiority of a newly licensed inactivated trivalent influenza vaccine versus an established vaccine: a randomized study in US adults. Hum Vaccin. 2011 Jan 1;7(1):81-8. doi: 10.4161/hv.7.1.13553. Epub 2011 Jan 1.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Prophylaxis: Influenza virus infection

Additional Relevant MeSH Terms

Other Study ID Numbers

104437

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

Informed Consent Form
Information identifier: 104437

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 104437

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 104437

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 104437

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 104437

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 104437

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 104437

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.