Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197288
First received: September 19, 2005
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Influenza
Biological: Influenza
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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)

Enrollment: 1847
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197288

Locations
United States, Florida
GSK Investigational Site
Clearwater, Florida, United States, 33761
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14209
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
GSK Investigational Site
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
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Katy, Texas, United States, 77450
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Campbell JD et al. A phase III study to evaluate the immunogenicity and safety of Fluarix® compared with Fluzone® in adults in the U.S. Abstract presented at the 10th Annual Conference on Vaccine Research sponsored by the National Foundation for Infectious Diseases (NFID). Baltimore, USA, 30 April -2 May 2007.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00197288     History of Changes
Other Study ID Numbers: 104437
Study First Received: September 19, 2005
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Prophylaxis: Influenza virus infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014