Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

GlaxoSmithKline1,596 enrolled

Overview

This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,596

Conditions

Influenza

Interventions

GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]BIOLOGICAL

Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.

GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]BIOLOGICAL

Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.

Fluarix [NH 2006/07 season]BIOLOGICAL

Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female aged 65 years or older at the time of the vaccination. * Written informed consent obtained from the subject. * Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use 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 Visit 2 after vaccination. * Planned administration of an influenza vaccine other than the study vaccines during the entire study period. * Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine). * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of hypersensivity to a previous dose of influenza vaccine. * History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. * Any medical conditions in which intramuscular injections are contraindicated.

Locations (6)

GSK Investigational Site

Soeborg, Denmark

GSK Investigational Site

Tartu, Estonia

GSK Investigational Site

Bergen, Norway

GSK Investigational Site

Elverum, Norway

Outcomes

Primary Outcomes

Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain

Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.

Time frame: At Days 0 and 21

Secondary Outcomes

HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations

Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.

Time frame: At Days 0 and 21

The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations

A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.

Time frame: At Day 21

HI Antibody Seroconversion Factors

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Fluarix [NH 2007/08 season]BIOLOGICAL

Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.

GSK Investigational Site

Stavanger, Norway

Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.

Time frame: At Day 21

The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere \[NH\] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.

Time frame: At Days 0 and 21

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. \>100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was \>20mm.

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

Duration of Solicited Local AEs

Duration was defined as number of days with any grade of local symptoms.

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

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.

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

Duration of Solicited General AEs

Duration was defined as number of days with any grade of general symptoms.

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

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs

Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

Time frame: During a 21-day follow-up period (Day 0-20) after vaccination

Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)

MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.

Time frame: During a 21-day follow-up period (Day 0-20) after vaccination

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Time frame: During a 21-day follow-up period (Day 0-20) after vaccination