Study to Evaluate an Influenza Vaccine Candidate

GlaxoSmithKline1,220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,220

Conditions

Influenza

Interventions

Candidate Influenza Vaccine GSK1247446A - 2 different formulationsBIOLOGICAL

Single dose, Intramuscular injection

FluarixTMBIOLOGICAL

Single dose, Intramuscular injection

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (17)

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Jarvenpaa, Finland

Outcomes

Primary Outcomes

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus

Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.

Time frame: At Days 0 and 21 post-vaccination

Secondary Outcomes

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus

Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.

Time frame: At Day 180 post-vaccination.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Time frame: During the 7-day (Days 0-6) follow-up period after vaccination

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 7-day (Days 0-6) follow up period after vaccination

Number of Subjects With Unsolicited Adverse Events (AEs).

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Data from ClinicalTrials.gov

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