Clinical trial NCT00321373: Study to Evaluate an Influenza Vaccine Candidate
Official title: A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 1220
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 study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Detailed description: Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events.

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 hypersensivity to a previous dose of influenza vaccine.
* Previous vaccination against influenza within the 9 months prior to enrollment.
* 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 Virus
timeFrame: At Days 0 and 21 post-vaccination
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
timeFrame: At Day 180 post-vaccination.
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6) follow up period after vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: During the 30-day (Days 0-29) follow-up period after vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 to Day 180)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kotka
country: Finland
facility: GSK Investigational Site
city: Lahti
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
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: Thessaloniki
country: Greece
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: