Clinical trial NCT00321763: Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate
Official title: Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-04
Enrollment: 3124
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Detailed description: The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility criteria: Inclusion Criteria:

* A male or female age 60 years or older at the time of the vaccination.
* Subjects who the investigator believes can and will comply with the requirements of the protocol
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

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.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of confirmed influenza infection within the last 12 months.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute disease at the time of enrolment

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Days 0 and 21
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Days 0 and 21
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
measure: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) post vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6) post vaccination period
measure: Number of Subjects With New Onset of Chronic Diseases (NOCDs).
timeFrame: From Day 0 to Day 180
measure: Number of Subjects With Medically Significant Conditions (MSCs).
timeFrame: From Day 0 to Day 180
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 30-day (Days 0-29) post-vaccination period
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Days 0-180)
Secondary outcomes:
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Caen cedex 4
country: France
facility: GSK Investigational Site
city: Gières
country: France
facility: GSK Investigational Site
city: Lagord
country: France
facility: GSK Investigational Site
city: Lille
country: France
facility: GSK Investigational Site
city: Montpellier Cedex 5
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Poitiers
country: France
facility: GSK Investigational Site
city: Rouen
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Haag
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hoehenkirchen-Siegertsbrunn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Marktl
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Oberaudorf
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Ketzin
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Koenigslutter
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Tostedt
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wolmirstedt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Delitzsch
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kamenz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Weissenberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Bramstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Athens
country: Greece
facility: GSK Investigational Site
city: Goudi / Athens
country: Greece
facility: GSK Investigational Site
city: Haidari
country: Greece
facility: GSK Investigational Site
city: Marousi
country: Greece
facility: GSK Investigational Site
city: Nikaia Piraeus
country: Greece
facility: GSK Investigational Site
city: Orestiada
country: Greece
facility: GSK Investigational Site
city: Papagos/Athens
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Elverum
country: Norway
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Paradis
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Reading
country: United Kingdom
facility: GSK Investigational Site
state: Berkshire
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
state: Glamorgan
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Edgbaston, Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: