Trial Outcomes & Findings for A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk (NCT NCT00586469)
NCT ID: NCT00586469
Last Updated: 2019-06-27
Results Overview
GMTs for H1 strain is addressed as a secondary endpoint
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1000 participants
Primary outcome timeframe
At Day 21
Results posted on
2019-06-27
Participant Flow
Participant milestones
| Measure |
Old Bulk
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Overall Study
STARTED
|
500
|
500
|
|
Overall Study
COMPLETED
|
500
|
499
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Old Bulk
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
Baseline characteristics by cohort
| Measure |
Old Bulk
n=500 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=500 Participants
This group received a full dose of Fluviral made from new material
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
296 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
576 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.
GMTs for H1 strain is addressed as a secondary endpoint
Outcome measures
| Measure |
Old Bulk
n=298 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=291 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Anti-H3 and B Strains
Anti-H3N2 antibody GMT
|
369.6 Titer
Interval 323.4 to 422.4
|
331.2 Titer
Interval 288.8 to 379.7
|
|
Geometric Mean Titers (GMTs) of Anti-H3 and B Strains
Anti-B antibody GMT
|
269.6 Titer
Interval 241.6 to 300.9
|
245.0 Titer
Interval 216.7 to 276.9
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.
The table contains GMTs of the H1 strains at Day 0 \& 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)
Outcome measures
| Measure |
Old Bulk
n=298 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=292 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
Anti-H1N1 antibody GMT at Day 0 (n=297, 292)
|
15.1 Titer
Interval 13.1 to 17.4
|
15.7 Titer
Interval 13.6 to 18.1
|
|
Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
Anti-H1N1 antibody GMT at Day 21 (n=298, 291)
|
188.1 Titer
Interval 163.6 to 216.4
|
169.9 Titer
Interval 147.3 to 196.1
|
|
Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
Anti-H3N2 antibody GMT at Day 0 (n=297, 292)
|
30.4 Titer
Interval 25.8 to 35.9
|
35.7 Titer
Interval 30.1 to 42.3
|
|
Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
Anti-B antibody GMT at Day 0 (n=297, 292)
|
29.3 Titer
Interval 25.3 to 33.9
|
30.0 Titer
Interval 25.8 to 34.9
|
SECONDARY outcome
Timeframe: At Day 21.Population: Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.
The table shows the number of participants who have either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a prevaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.
Outcome measures
| Measure |
Old Bulk
n=297 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=291 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Number of Participants Who Seroconverted.
Anti-H1N1
|
218 participants
|
197 participants
|
|
Number of Participants Who Seroconverted.
Anti-H3N2
|
212 participants
|
187 participants
|
|
Number of Participants Who Seroconverted.
Anti-B
|
205 participants
|
185 participants
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.
The table presents the number of participants with a serum haemagglutination inhibition (HI) titer \>= 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Old Bulk
n=298 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=292 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Number of Seroprotected Participants.
Anti-H1N1 at Day 0 (n=297, 292)
|
80 participants
|
90 participants
|
|
Number of Seroprotected Participants.
Anti-H1N1 at Day 21 (n=298, 291)
|
276 participants
|
266 participants
|
|
Number of Seroprotected Participants.
Anti-H3N2 at Day 0 (n=297, 292)
|
149 participants
|
154 participants
|
|
Number of Seroprotected Participants.
Anti-H3N2 at Day 21 (n=298, 291)
|
293 participants
|
286 participants
|
|
Number of Seroprotected Participants.
Anti-B antibody GMT at Day 0 (n=297, 292)
|
144 participants
|
150 participants
|
|
Number of Seroprotected Participants.
Anti-B antibody GMT at Day21 (n=298, 291)
|
295 participants
|
285 participants
|
SECONDARY outcome
Timeframe: At Day 21 compared to Day 0Population: Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.
Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.
Outcome measures
| Measure |
Old Bulk
n=297 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=291 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1
|
12.5 Factor
|
10.8 Factor
|
SECONDARY outcome
Timeframe: At Day 21 compared to Day 0Population: Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.
The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The "fold increase" corresponds to the Unit of Measure "Factor."
Outcome measures
| Measure |
Old Bulk
n=297 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=291 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B
Anti-H3N2
|
12.1 Factor
|
9.2 Factor
|
|
The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B
Anti-B
|
9.2 Factor
|
8.1 Factor
|
SECONDARY outcome
Timeframe: During the 4-day follow up period following vaccination.Population: Analysis was performed on the Total Vaccinated cohort.
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Old Bulk
n=500 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=500 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Number of Participants Reporting Solicited Local Symptoms
Pain
|
271 participants
|
290 participants
|
|
Number of Participants Reporting Solicited Local Symptoms
Redness
|
88 participants
|
97 participants
|
|
Number of Participants Reporting Solicited Local Symptoms
Swelling
|
59 participants
|
63 participants
|
SECONDARY outcome
Timeframe: During the 4-day period following each vaccination.Population: Analysis was performed on the Total Vaccinated cohort.
Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face
Outcome measures
| Measure |
Old Bulk
n=500 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=500 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Number of Participants Reporting Solicited General Symptoms
Swelling of the face
|
9 participants
|
11 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Bronchospasm
|
26 participants
|
24 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Chills
|
60 participants
|
45 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Cough
|
50 participants
|
53 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Fatigue
|
113 participants
|
113 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Axillary fever >= 37.5° Celsius (C)
|
18 participants
|
9 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Headache
|
110 participants
|
101 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Joint pain at other location
|
55 participants
|
50 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Muscle aches
|
141 participants
|
138 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Red eyes
|
32 participants
|
31 participants
|
|
Number of Participants Reporting Solicited General Symptoms
Sore throat
|
61 participants
|
62 participants
|
SECONDARY outcome
Timeframe: During the 21-day period following each vaccination.Population: The analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Old Bulk
n=500 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=500 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AE).
|
127 participants
|
129 participants
|
SECONDARY outcome
Timeframe: Within 21 days after vaccinationAn 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.
Outcome measures
| Measure |
Old Bulk
n=500 Participants
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=500 Participants
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAE)
Fatal SAE
|
0 participants
|
0 participants
|
|
Number of Participants Reporting Serious Adverse Events (SAE)
Any SAE
|
0 participants
|
4 participants
|
Adverse Events
Old Bulk
Serious events: 0 serious events
Other events: 271 other events
Deaths: 0 deaths
New Bulk
Serious events: 4 serious events
Other events: 290 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Old Bulk
n=500 participants at risk
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=500 participants at risk
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
0.40%
2/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
0.20%
1/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
0.20%
1/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
Loss of consciousness
|
0.00%
0/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
0.20%
1/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
Other adverse events
| Measure |
Old Bulk
n=500 participants at risk
This group received a full dose of Fluviral made from aged bulk material
|
New Bulk
n=500 participants at risk
This group received a full dose of Fluviral made from new material
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.8%
19/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
5.2%
26/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
Pain
|
54.2%
271/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
58.0%
290/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
Redness
|
17.6%
88/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
19.4%
97/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
Swelling
|
11.8%
59/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
12.6%
63/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
Bronchospasm
|
5.2%
26/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
4.8%
24/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
|
12.0%
60/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
9.0%
45/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
|
10.0%
50/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
10.6%
53/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
|
22.6%
113/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
22.6%
113/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
|
22.0%
110/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
20.2%
101/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
|
11.0%
55/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
10.0%
50/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
|
28.2%
141/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
27.6%
138/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
Red eyes
|
6.4%
32/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
6.2%
31/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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
Sore throat
|
12.2%
61/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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.
|
12.4%
62/500 • Solicited AEs were reported during the 4-day follow up period following vaccination; unsolicited AEs during the 21-day period following each vaccination and SAEs during the entire study period (within 21 days after vaccination)
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