Clinical trial NCT00197223: Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 6213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of culture confirmed influenza A and/or B during the surveillance period
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Beran J, Wertzova V, Honegr K, Kaliskova E, Havlickova M, Havlik J, Jirincova H, Van Belle P, Jain V, Innis B, Devaster JM. Challenge of conducting a placebo-controlled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: a concrete example. BMC Infect Dis. 2009 Jan 17;9:2. doi: 10.1186/1471-2334-9-2.