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Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00197288
Collaborator
(none)
1,847
Enrollment
15
Locations
8
Duration (Months)
123.1
Patients Per Site
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Influenza
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
1847 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
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.
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs) []

Secondary Outcome Measures

  1. Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs) []

  2. Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age []

  3. Safety comparison (sol local, general & unsol AEs, SAEs) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Clearwater Florida United States 33761
2 GSK Investigational Site Evansville Indiana United States 47714
3 GSK Investigational Site Baltimore Maryland United States 21201
4 GSK Investigational Site St. Louis Missouri United States 63110
5 GSK Investigational Site Buffalo New York United States 14209
6 GSK Investigational Site Poughkeepsie New York United States 12601
7 GSK Investigational Site Cincinnati Ohio United States 45229
8 GSK Investigational Site Carnegie Pennsylvania United States 15106
9 GSK Investigational Site Erie Pennsylvania United States 16506
10 GSK Investigational Site Philadelphia Pennsylvania United States 19107
11 GSK Investigational Site Pittsburgh Pennsylvania United States 15236
12 GSK Investigational Site Warwick Rhode Island United States 02886
13 GSK Investigational Site Houston Texas United States 77030
14 GSK Investigational Site Katy Texas United States 77450
15 GSK Investigational Site Marshfield Wisconsin United States 54449

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197288
Other Study ID Numbers:
  • 104437
First Posted:
Sep 20, 2005
Last Update Posted:
Jan 18, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Prophylaxis: Influenza virus infection
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Jan 18, 2017