Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00929331
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Actual Duration (Days): 21
• Patients Per Site Per Month: 159.4

Study Details

Study Description

Brief Summary

This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years.

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human	Biological: Fluviral®	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years.
• Actual Study Start Date: Jul 11, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluviral Adult Group Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Biological: Fluviral®; Intramuscular injection, one dose
Experimental: Fluviral Elderly Group Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Biological: Fluviral®; Intramuscular injection, one dose

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies [At Day 0]

   Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

2. GMTs of HI Antibodies [At Day 21 after vaccination]

   Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

3. Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value [At Day 0]

   The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

4. Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value [At Day 21 after vaccination]

   The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

5. Number of Seroconverted Subjects [At Day 21 after vaccination]

   A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

6. Seroconversion Factors [At Day 21 after vaccination]

   Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

7. Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value [At Day 21 after vaccination]

   The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

Secondary Outcome Measures

1. Number of Subjects Reporting Any Solicited Local Symptoms [During a 4-day (Day 0-3) follow-up period after vaccination]

   Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Any = Solicited local symptoms are presented regardless of their intensity grade

2. Number of Subjects Reporting Grade 3 Solicited Local Symptoms [During a 4-day (Day 0-3) follow-up period after vaccination]

   Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm

3. Number of Subjects Reporting Any Solicited General Symptoms [During a 4-day (Day 0-3) follow-up period after vaccination]

   Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination. For temperature this means equal to or above 38.0 degrees celsius.

4. Number of Subjects Reporting Grade 3 Solicited General Symptoms [During a 4-day (Day 0-3) follow-up period after vaccination]

   Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius

5. Number of Subjects Reporting Related Solicited General Symptoms [During a 4-day (Day 0-3) follow-up period after vaccination]

   Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Related = general symptom assessed by the investigator as related to the vaccine

6. Number of Subjects Reporting Unsolicited Adverse Events (AEs) [During a 21-day (Day 0-20) follow-up period after vaccination]

   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 = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.

7. Number of Subjects With Serious Adverse Events [From the beginning up to the end of the study (Day 0 - Day 21)]

   SAEs assessed include medical occurrences that result in death, is 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject

• Male and female adults, 18 to 60 years of age and over 60 years of age.

• 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.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test on the day of vaccination, and

• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Participation in previous year's (2008) Fluviral® registration study

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.

• Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <38.0°C.

• Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:

Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.

• 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 hemoglobinopathies 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. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.

• 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 Fluviral® and/or a history of anaphylactic type reaction to constituent of the vaccine.

• A history of severe adverse reaction to a previous influenza vaccination.

• Lactating/nursing female.

• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 1Z1

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00929331
• Other Study ID Numbers: 110586
• First Posted: Jun 29, 2009
• Last Update Posted: Nov 9, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Influenza; Fluviral®
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Period Title: Overall Study
STARTED	55	55
COMPLETED	55	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group	Total
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Total of all reporting groups
Overall Participants	55	55	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.1 (14.83)	66.8 (4.10)	51.0 (19.26)
Sex: Female, Male (Count of Participants)
Female	32 58.2%	31 56.4%	63 57.3%
Male	23 41.8%	24 43.6%	47 42.7%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies
Description	Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
A/Brisbane	27.2	22.8
A/Uruguay	33.3	45.9
B/Brisbane	36.8	48.3

2. Primary Outcome

Title	GMTs of HI Antibodies
Description	Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Time Frame	At Day 21 after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
A/Brisbane	139.2	40.2
A/Uruguay	273.3	141.0
B/Brisbane	230.6	131.5

3. Primary Outcome

Title	Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
Description	The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Time Frame	At Day 0

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
A/Brisbane	27	18
A/Uruguay	23	32
B/Brisbane	31	38

4. Primary Outcome

Title	Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
Description	The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Time Frame	At Day 21 after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
A/Brisbane	51	27
A/Uruguay	54	50
B/Brisbane	55	51

5. Primary Outcome

Title	Number of Seroconverted Subjects
Description	A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Time Frame	At Day 21 after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
A/Brisbane	26	8
U/Uruguay	35	17
B/Brisbane	38	17

6. Primary Outcome

Title	Seroconversion Factors
Description	Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Time Frame	At Day 21 after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
A/Brisbane	5.1	1.8
U/Uruguay	8.2	3.1
B/Brisbane	6.3	2.7

7. Primary Outcome

Title	Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value
Description	The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Time Frame	At Day 21 after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	32	37
A/Brisbane	24	9
A/Uruguay	31	18
B/Brisbane	24	13

8. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited Local Symptoms
Description	Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Any = Solicited local symptoms are presented regardless of their intensity grade
Time Frame	During a 4-day (Day 0-3) follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
Pain	34	16
Redness	1	0
Swelling	2	1

9. Secondary Outcome

Title	Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Description	Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm
Time Frame	During a 4-day (Day 0-3) follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
Pain	1	0
Redness	0	0
Swelling	0	0

10. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited General Symptoms
Description	Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination. For temperature this means equal to or above 38.0 degrees celsius.
Time Frame	During a 4-day (Day 0-3) follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
Bronchospasm	2	0
Chills	5	5
Cough	4	3
Fatigue	11	7
Headache	7	6
Joint pain at other location	5	3
Muscle aches	10	8
Red eyes	1	0
Sore throat	2	2
Swelling of the face	0	0
Temperature	1	0

11. Secondary Outcome

Title	Number of Subjects Reporting Grade 3 Solicited General Symptoms
Description	Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius
Time Frame	During a 4-day (Day 0-3) follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
Bronchospasm	0	0
Chills	0	0
Cough	0	0
Fatigue	0	1
Headache	0	0
Joint pain at other location	0	0
Muscle aches	0	0
Red eyes	0	0
Sore throat	0	0
Swelling of the face	0	0
Temperature	0	0

12. Secondary Outcome

Title	Number of Subjects Reporting Related Solicited General Symptoms
Description	Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Related = general symptom assessed by the investigator as related to the vaccine
Time Frame	During a 4-day (Day 0-3) follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
Bronchospasm	2	0
Chills	5	5
Cough	4	3
Fatigue	11	7
Headache	7	6
Joint pain at other location	5	3
Muscle aches	10	8
Red eyes	1	0
Sore throat	2	2
Swelling of the face	0	0
Temperature	1	0

13. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description	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 = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Time Frame	During a 21-day (Day 0-20) follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
Any	13	4
Grade 3	1	0
Related	3	0

14. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events
Description	SAEs assessed include medical occurrences that result in death, is 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.
Time Frame	From the beginning up to the end of the study (Day 0 - Day 21)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluviral Adult Group	Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Measure Participants	55	55
Number [subjects]	0	0

Adverse Events

Time Frame	Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events were collected during the 21-day (Day 0-20) post-vaccination period.
Adverse Event Reporting Description	For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Arm/Group Title	Fluviral Adult Group		Fluviral Elderly Group
Arm/Group Description	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm		Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
All Cause Mortality
	Fluviral Adult Group		Fluviral Elderly Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Serious Adverse Events
	Fluviral Adult Group		Fluviral Elderly Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Fluviral Adult Group		Fluviral Elderly Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/55 (61.8%)		16/55 (29.1%)
General disorders
Pain	34/55 (61.8%)		16/55 (29.1%)
chills	5/55 (9.1%)		5/55 (9.1%)
Cough	4/55 (7.3%)		3/55 (5.5%)
Fatigue	11/55 (20%)		7/55 (12.7%)
Headache	7/55 (12.7%)		6/55 (10.9%)
Joint pain at other location	5/55 (9.1%)		3/55 (5.5%)
Muscle aches	10/55 (18.2%)		8/55 (14.5%)
Infections and infestations
Upper respiratory tract infection	3/55 (5.5%)		0/55 (0%)
Nervous system disorders
Headache	3/55 (5.5%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.