Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197223
First received: September 15, 2005
Last updated: January 31, 2012
Last verified: January 2012
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: Influenza vaccine |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | 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. |
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:
- Incidence of culture confirmed influenza A and/or B during the surveillance period
Secondary Outcome Measures:
- 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
Enrollment: | 6213 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | NCT00197223 History of Changes |
Other Study ID Numbers: | 104438 |
Study First Received: | September 15, 2005 |
Last Updated: | January 31, 2012 |
Health Authority: | United States: Food and Drug Administration |
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