Influenza Vaccines
Conditions
Keywords
Fluviral, Influenza
Brief summary
This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.
Interventions
BIOLOGICALFluviral®
One intramuscular injection into the deltoid region of the non-dominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * Male and female adults, 18 to 60 years of age and over 60 years of age. * Written informed consent obtained from the subject. * Satisfactory baseline medical assessment by history and physical examination. * Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Exclusion criteria
* Acute disease at the time of enrollment. * Significant acute or chronic, uncontrolled medical or psychiatric illness. * Any confirmed or suspected immunosuppressive condition including: * History of human immunodeficiency virus (HIV) infection, * Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * History of renal impairment. * History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol. * Complicated insulin-dependent diabetes mellitus. * Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment. * Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder. * Receipt of systemic glucocorticoids within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed. * A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome. * Presence of an active neurological disorder. * History of chronic alcohol consumption and/or drug abuse. * Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible. * Receipt of an influenza vaccine within 6 months prior to study enrollment. * Administration of any vaccines within 30 days prior to study enrollment or during the study period. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. * Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. * Any known or suspected allergy to any constituent of the vaccine. * A history of severe adverse reaction to a previous influenza vaccination. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study. * Lactating/nursing female. * Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects | At Day 0 and 21 | Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains. |
| Hemagglutination Inhibition (HI) Antibody Titers | At Day 0 and 21 | Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains. |
| Number of Seroconverted Subjects | At Day 21 | Seroconversion, defined as a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains. |
| Fold Increase From Baseline in Serum HI Antibody Titer | At Day 21 | The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | During the 21-day (Day 0-20) post-vaccination period | An AE is 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. |
| Number of Subjects Reporting Serious Adverse Events (SAE) | During the 21-day (Day 0-20) post-vaccination period | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Number of Subjects Reporting Solicited Symptoms | During the 4-day (Day 0-3) post-vaccination period | Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluviral Adult Group Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine. | 55 |
| Fluviral Elderly Group Subjects aged more than 60 years received a single dose of Fluviral® vaccine. | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Fluviral Adult Group | Fluviral Elderly Group | Total |
|---|---|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 12.16 | 66.4 years STANDARD_DEVIATION 4.61 | 53.2 years STANDARD_DEVIATION 16.08 |
| Sex: Female, Male Female | 36 Participants | 35 Participants | 71 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 36 / 55 | 13 / 55 |
| serious Total, serious adverse events | 0 / 55 | 1 / 55 |
Outcome results
Primary
Fold Increase From Baseline in Serum HI Antibody Titer
The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.
Time frame: At Day 21
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral Adult Group | Fold Increase From Baseline in Serum HI Antibody Titer | A/Brisbane (H1N1) | 6.0 fold increase |
| Fluviral Adult Group | Fold Increase From Baseline in Serum HI Antibody Titer | A/Uruguay (H3N2) | 12.8 fold increase |
| Fluviral Adult Group | Fold Increase From Baseline in Serum HI Antibody Titer | B/Florida | 8.1 fold increase |
| Fluviral Elderly Group | Fold Increase From Baseline in Serum HI Antibody Titer | A/Brisbane (H1N1) | 3.4 fold increase |
| Fluviral Elderly Group | Fold Increase From Baseline in Serum HI Antibody Titer | A/Uruguay (H3N2) | 7.3 fold increase |
| Fluviral Elderly Group | Fold Increase From Baseline in Serum HI Antibody Titer | B/Florida | 5.0 fold increase |
Primary
Hemagglutination Inhibition (HI) Antibody Titers
Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.
Time frame: At Day 0 and 21
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluviral Adult Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Brisbane (H1N1) [Day 0] | 19.5 titer |
| Fluviral Adult Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Brisbane (H1N1) [Day 21] | 116.0 titer |
| Fluviral Adult Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Uruguay (H3N2) [Day 0] | 19.1 titer |
| Fluviral Adult Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Uruguay (H3N2) [Day 21] | 244.0 titer |
| Fluviral Adult Group | Hemagglutination Inhibition (HI) Antibody Titers | B/Florida [Day 0] | 59.8 titer |
| Fluviral Adult Group | Hemagglutination Inhibition (HI) Antibody Titers | B/Florida [Day 21] | 485.0 titer |
| Fluviral Elderly Group | Hemagglutination Inhibition (HI) Antibody Titers | B/Florida [Day 0] | 51.4 titer |
| Fluviral Elderly Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Brisbane (H1N1) [Day 0] | 13.9 titer |
| Fluviral Elderly Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Uruguay (H3N2) [Day 21] | 170.3 titer |
| Fluviral Elderly Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Brisbane (H1N1) [Day 21] | 47.1 titer |
| Fluviral Elderly Group | Hemagglutination Inhibition (HI) Antibody Titers | B/Florida [Day 21] | 256.6 titer |
| Fluviral Elderly Group | Hemagglutination Inhibition (HI) Antibody Titers | A/Uruguay (H3N2) [Day 0] | 23.2 titer |
Primary
Number of Seroconverted Subjects
Seroconversion, defined as a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.
Time frame: At Day 21
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral Adult Group | Number of Seroconverted Subjects | A/Brisbane (H1N1) | 28 subjects |
| Fluviral Adult Group | Number of Seroconverted Subjects | A/Uruguay (H3N2) | 40 subjects |
| Fluviral Adult Group | Number of Seroconverted Subjects | B/Florida | 38 subjects |
| Fluviral Elderly Group | Number of Seroconverted Subjects | A/Brisbane (H1N1) | 18 subjects |
| Fluviral Elderly Group | Number of Seroconverted Subjects | A/Uruguay (H3N2) | 35 subjects |
| Fluviral Elderly Group | Number of Seroconverted Subjects | B/Florida | 25 subjects |
Primary
Number of Seroprotected Subjects
Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.
Time frame: At Day 0 and 21
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral Adult Group | Number of Seroprotected Subjects | A/Brisbane (H1N1) [Day 21] | 52 subjects |
| Fluviral Adult Group | Number of Seroprotected Subjects | A/Uruguay (H3N2) [Day 21] | 53 subjects |
| Fluviral Adult Group | Number of Seroprotected Subjects | B/Florida [Day 0] | 36 subjects |
| Fluviral Adult Group | Number of Seroprotected Subjects | B/Florida [Day 21] | 55 subjects |
| Fluviral Adult Group | Number of Seroprotected Subjects | A/Brisbane (H1N1) [Day 0] | 21 subjects |
| Fluviral Adult Group | Number of Seroprotected Subjects | A/Uruguay (H3N2) [Day 0] | 21 subjects |
| Fluviral Elderly Group | Number of Seroprotected Subjects | A/Brisbane (H1N1) [Day 0] | 15 subjects |
| Fluviral Elderly Group | Number of Seroprotected Subjects | A/Uruguay (H3N2) [Day 0] | 20 subjects |
| Fluviral Elderly Group | Number of Seroprotected Subjects | B/Florida [Day 21] | 55 subjects |
| Fluviral Elderly Group | Number of Seroprotected Subjects | A/Uruguay (H3N2) [Day 21] | 50 subjects |
| Fluviral Elderly Group | Number of Seroprotected Subjects | A/Brisbane (H1N1) [Day 21] | 36 subjects |
| Fluviral Elderly Group | Number of Seroprotected Subjects | B/Florida [Day 0] | 37 subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the 21-day (Day 0-20) post-vaccination period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluviral Adult Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 0 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 1 subjects |
Secondary
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.
Time frame: During the 4-day (Day 0-3) post-vaccination period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Pain | 36 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Redness | 0 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Swelling | 2 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Bronchospasm | 1 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Chills | 2 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Cough | 1 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Fatigue | 10 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Headache | 14 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Joint pain at other location | 5 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Muscle aches | 19 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Red eyes | 3 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Sore throat | 7 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Swelling of the face | 0 subjects |
| Fluviral Adult Group | Number of Subjects Reporting Solicited Symptoms | Fever | 1 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Red eyes | 4 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Pain | 13 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Headache | 6 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Redness | 0 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Swelling of the face | 0 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Swelling | 0 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Joint pain at other location | 6 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Bronchospasm | 2 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Sore throat | 3 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Chills | 0 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Muscle aches | 11 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Cough | 4 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Fever | 0 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Solicited Symptoms | Fatigue | 8 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is 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.
Time frame: During the 21-day (Day 0-20) post-vaccination period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluviral Adult Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 9 subjects |
| Fluviral Elderly Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 8 subjects |