Trial Outcomes & Findings for Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years (NCT NCT00929331)
NCT ID: NCT00929331
Last Updated: 2020-11-09
Results Overview
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
110 participants
Primary outcome timeframe
At Day 0
Results posted on
2020-11-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years
Baseline characteristics by cohort
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 14.83 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 4.10 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 19.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: 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.
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies
A/Brisbane
|
27.2 titer
Interval 18.8 to 39.5
|
22.8 titer
Interval 16.8 to 31.1
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies
A/Uruguay
|
33.3 titer
Interval 21.8 to 50.7
|
45.9 titer
Interval 31.3 to 67.3
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies
B/Brisbane
|
36.8 titer
Interval 26.5 to 51.1
|
48.3 titer
Interval 34.4 to 67.7
|
PRIMARY outcome
Timeframe: At Day 21 after vaccinationPopulation: 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.
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
GMTs of HI Antibodies
A/Brisbane
|
139.2 titer
Interval 101.6 to 190.6
|
40.2 titer
Interval 29.7 to 54.5
|
|
GMTs of HI Antibodies
A/Uruguay
|
273.3 titer
Interval 192.8 to 387.3
|
141.0 titer
Interval 100.0 to 198.8
|
|
GMTs of HI Antibodies
B/Brisbane
|
230.6 titer
Interval 177.4 to 299.7
|
131.5 titer
Interval 95.2 to 181.7
|
PRIMARY outcome
Timeframe: At Day 0Population: 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.
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.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
A/Brisbane
|
27 subjects
|
18 subjects
|
|
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
A/Uruguay
|
23 subjects
|
32 subjects
|
|
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
B/Brisbane
|
31 subjects
|
38 subjects
|
PRIMARY outcome
Timeframe: At Day 21 after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
A/Brisbane
|
51 subjects
|
27 subjects
|
|
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
A/Uruguay
|
54 subjects
|
50 subjects
|
|
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
B/Brisbane
|
55 subjects
|
51 subjects
|
PRIMARY outcome
Timeframe: At Day 21 after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Seroconverted Subjects
A/Brisbane
|
26 subjects
|
8 subjects
|
|
Number of Seroconverted Subjects
U/Uruguay
|
35 subjects
|
17 subjects
|
|
Number of Seroconverted Subjects
B/Brisbane
|
38 subjects
|
17 subjects
|
PRIMARY outcome
Timeframe: At Day 21 after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Seroconversion Factors
A/Brisbane
|
5.1 ratio
Interval 3.3 to 8.0
|
1.8 ratio
Interval 1.4 to 2.2
|
|
Seroconversion Factors
U/Uruguay
|
8.2 ratio
Interval 5.4 to 12.5
|
3.1 ratio
Interval 2.2 to 4.3
|
|
Seroconversion Factors
B/Brisbane
|
6.3 ratio
Interval 4.5 to 8.8
|
2.7 ratio
Interval 2.0 to 3.7
|
PRIMARY outcome
Timeframe: At Day 21 after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Fluviral Adult Group
n=32 Participants
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
|
Fluviral Elderly Group
n=37 Participants
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
|
|---|---|---|
|
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
A/Brisbane
|
24 subjects
|
9 subjects
|
|
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
A/Uruguay
|
31 subjects
|
18 subjects
|
|
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
B/Brisbane
|
24 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: During a 4-day (Day 0-3) follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.
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
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Swelling
|
2 subjects
|
1 subjects
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Pain
|
34 subjects
|
16 subjects
|
|
Number of Subjects Reporting Any Solicited Local Symptoms
Redness
|
1 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: During a 4-day (Day 0-3) follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.
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
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Swelling
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Pain
|
1 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Redness
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: During a 4-day (Day 0-3) follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.
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.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Any Solicited General Symptoms
Bronchospasm
|
2 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Chills
|
5 subjects
|
5 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Cough
|
4 subjects
|
3 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Fatigue
|
11 subjects
|
7 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Headache
|
7 subjects
|
6 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Joint pain at other location
|
5 subjects
|
3 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Muscle aches
|
10 subjects
|
8 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Red eyes
|
1 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Sore throat
|
2 subjects
|
2 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Swelling of the face
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Temperature
|
1 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: During a 4-day (Day 0-3) follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.
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
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Headache
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Joint pain at other location
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Muscle aches
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Red eyes
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Bronchospasm
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Chills
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Cough
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Fatigue
|
0 subjects
|
1 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Sore throat
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Swelling of the face
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Temperature
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: During a 4-day (Day 0-3) follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.
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
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Related Solicited General Symptoms
Cough
|
4 subjects
|
3 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Fatigue
|
11 subjects
|
7 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Bronchospasm
|
2 subjects
|
0 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Chills
|
5 subjects
|
5 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Headache
|
7 subjects
|
6 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Joint pain at other location
|
5 subjects
|
3 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Muscle aches
|
10 subjects
|
8 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Red eyes
|
1 subjects
|
0 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Sore throat
|
2 subjects
|
2 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Swelling of the face
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Related Solicited General Symptoms
Temperature
|
1 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: During a 21-day (Day 0-20) follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.
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.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Any
|
13 subjects
|
4 subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Grade 3
|
1 subjects
|
0 subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Related
|
3 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Fluviral Adult Group
n=55 Participants
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
|
Fluviral Elderly Group
n=55 Participants
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
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
0 subjects
|
0 subjects
|
Adverse Events
Fluviral Adult Group
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Fluviral Elderly Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluviral Adult Group
n=55 participants at risk
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
|
Fluviral Elderly Group
n=55 participants at risk
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
|
|---|---|---|
|
General disorders
Pain
|
61.8%
34/55 • 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.
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.
|
29.1%
16/55 • 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.
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.
|
|
General disorders
chills
|
9.1%
5/55 • 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.
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.
|
9.1%
5/55 • 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.
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.
|
|
General disorders
Cough
|
7.3%
4/55 • 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.
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.
|
5.5%
3/55 • 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.
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.
|
|
General disorders
Fatigue
|
20.0%
11/55 • 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.
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.
|
12.7%
7/55 • 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.
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.
|
|
General disorders
Headache
|
12.7%
7/55 • 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.
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.
|
10.9%
6/55 • 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.
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.
|
|
General disorders
Joint pain at other location
|
9.1%
5/55 • 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.
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.
|
5.5%
3/55 • 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.
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.
|
|
General disorders
Muscle aches
|
18.2%
10/55 • 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.
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.
|
14.5%
8/55 • 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.
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.
|
|
Nervous system disorders
Headache
|
5.5%
3/55 • 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.
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.
|
0.00%
0/55 • 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.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
3/55 • 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.
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.
|
0.00%
0/55 • 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.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER