Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate

GlaxoSmithKline678 enrolled

Overview

The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

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

TRIPLE

Enrollment

678

Conditions

Influenza

Interventions

Influenza Vaccine GSK1247446ABIOLOGICAL

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 revaccination, who previously participated in 107192 \& 107214 clinical trials. * 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 3 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.

Locations (4)

GSK Investigational Site

Elverum, Norway

GSK Investigational Site

Hamar, Norway

GSK Investigational Site

Paradis, Norway

GSK Investigational Site

Stavanger, Norway

Outcomes

Primary Outcomes

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

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).

Time frame: During the 7-day (Days 0-6) post-vaccination period

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

Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature \> 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.

Time frame: During the 7-day (Days 0-6) post-vaccination period

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (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 = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.

Time frame: During the 30-day (Days 0-29) post vaccination period

Number of Subjects With 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 SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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

Time frame: At Day 0 and Day 21

Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

Time frame: At Day 21

Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

Time frame: At Day 0 and Day 21

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

Time frame: At Day 21