Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197288
First received: September 19, 2005
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
Detailed Description:
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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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) |
- 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
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
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided by GlaxoSmithKline
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 October 16, 2012