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Trial record 67 of 597 for:    Fluzone® | Studies With Results

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00383123
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : December 4, 2008
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Fluarix™
Biological: Fluzone
Enrollment 3327

Recruitment Details  
Pre-assignment Details Two subjects, enrolled in the Fluzone Group, were not vaccinated; therefore, they were not included in the number of subjects included under "STARTED".
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Period Title: Overall Study
Started 2115 1210
Completed 2004 1124
Not Completed 111 86
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             68             61
Protocol Violation             5             1
Withdrawal by Subject             27             18
Other reason             10             6
Arm/Group Title Fluarix Group Fluzone Group Total
Hide Arm/Group Description

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Total of all reporting groups
Overall Number of Baseline Participants 2115 1210 3325
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2115 participants 1210 participants 3325 participants
7.6  (4.97) 5.5  (4.75) 6.8  (4.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2115 participants 1210 participants 3325 participants
Female
1038
  49.1%
586
  48.4%
1624
  48.8%
Male
1077
  50.9%
624
  51.6%
1701
  51.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2115 participants 1210 participants 3325 participants
African heritage / african american
344
  16.3%
238
  19.7%
582
  17.5%
American indian or alaskan native
78
   3.7%
45
   3.7%
123
   3.7%
Asian - central/south asian heritage
13
   0.6%
7
   0.6%
20
   0.6%
Asian - east asian heritage
15
   0.7%
13
   1.1%
28
   0.8%
Asian - japanese heritage
3
   0.1%
1
   0.1%
4
   0.1%
Asian - south east asian heritage
21
   1.0%
17
   1.4%
38
   1.1%
Native hawaiian or other pacific island
14
   0.7%
10
   0.8%
24
   0.7%
White - arabic / north african heritage
29
   1.4%
17
   1.4%
46
   1.4%
White - caucasian / european heritage
1477
  69.8%
794
  65.6%
2271
  68.3%
Unspecified
121
   5.7%
68
   5.6%
189
   5.7%
1.Primary Outcome
Title Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
Hide Description GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Time Frame 21 or 28 days after last vaccine dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to < 5 years).
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 426 445
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/New Caledonia [6 to <36 months] Number Analyzed 206 participants 224 participants
52.4
(43.3 to 63.4)
101.4
(86.9 to 118.2)
A/Wisconsin [6 to <36 months] Number Analyzed 206 participants 224 participants
80.5
(62.2 to 104.1)
218.0
(185.8 to 255.8)
B/Malaysia [6 to <36 months] Number Analyzed 206 participants 224 participants
20.2
(15.9 to 25.8)
40.6
(32.3 to 51.1)
A/New Caledonia [3 to < 5 years] Number Analyzed 220 participants 221 participants
130.3
(108.6 to 156.4)
168.7
(138.7 to 205.2)
A/Wisconsin [3 to < 5 years] Number Analyzed 220 participants 221 participants
458.1
(365.3 to 574.3)
483.4
(396.8 to 588.9)
B/Malaysia [3 to < 5 years] Number Analyzed 220 participants 221 participants
54.9
(42.3 to 71.1)
64.4
(49.5 to 83.8)
2.Primary Outcome
Title Number of Seroconverted Subjects
Hide Description

Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.

Data are presented for all 3 viral strains comprised in the vaccine.

Time Frame 21 or 28 days after last vaccine dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom post-vaccination results were available.
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 425 443
Measure Type: Count of Participants
Unit of Measure: Participants
A/New Caledonia [6 to <36 months] Number Analyzed 205 participants 223 participants
105
  51.2%
179
  80.3%
A/Wisconsin [6 to <36 months] Number Analyzed 205 participants 223 participants
117
  57.1%
190
  85.2%
B/Malaysia [6 to <36 months] Number Analyzed 205 participants 223 participants
48
  23.4%
114
  51.1%
A/New Caledonia [3 to <5 years] Number Analyzed 220 participants 220 participants
160
  72.7%
159
  72.3%
A/Wisconsin [3 to <5 years] Number Analyzed 220 participants 220 participants
156
  70.9%
155
  70.5%
B/Malaysia [3 to <5 years] Number Analyzed 220 participants 220 participants
117
  53.2%
122
  55.5%
3.Primary Outcome
Title Number of Subjects Reporting Rare Serious Events
Hide Description

Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:

  • resulted in death,
  • was life-threatening,
  • required hospitalization or prolongation of existing hospitalization,
  • resulted in disability/incapacity, or
  • was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Up to 6 months after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 2115 1210
Measure Type: Count of Participants
Unit of Measure: Participants
11
   0.5%
11
   0.9%
4.Secondary Outcome
Title Number of Seroprotected Subjects
Hide Description Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Time Frame Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom results were available.
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 426 445
Measure Type: Count of Participants
Unit of Measure: Participants
A/New Caledonia [6 to <36 months] PRE Number Analyzed 205 participants 223 participants
15
   7.3%
16
   7.2%
A/New Caledonia [6 to <36 months] POST Number Analyzed 206 participants 224 participants
122
  59.2%
193
  86.2%
A/Wisconsin [6 to <36 months] PRE Number Analyzed 205 participants 223 participants
39
  19.0%
44
  19.7%
A/Wisconsin [6 to <36 months] POST Number Analyzed 206 participants 224 participants
135
  65.5%
211
  94.2%
B/Malaysia [6 to <36 months] PRE Number Analyzed 205 participants 223 participants
11
   5.4%
12
   5.4%
B/Malaysia [6 to <36 months] POST Number Analyzed 206 participants 224 participants
50
  24.3%
115
  51.3%
A/New Caledonia [3 to <5 years] PRE Number Analyzed 220 participants 220 participants
38
  17.3%
45
  20.5%
A/New Caledonia [3 to <5 years] POST Number Analyzed 220 participants 221 participants
180
  81.8%
189
  85.5%
A/Wisconsin [3 to <5 years] PRE Number Analyzed 220 participants 220 participants
131
  59.5%
122
  55.5%
A/Wisconsin [3 to <5 years] POST Number Analyzed 220 participants 221 participants
194
  88.2%
207
  93.7%
B/Malaysia [3 to <5 years] PRE Number Analyzed 220 participants 220 participants
30
  13.6%
26
  11.8%
B/Malaysia [3 to <5 years] POST Number Analyzed 220 participants 221 participants
121
  55.0%
129
  58.4%
5.Secondary Outcome
Title Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
Hide Description Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Time Frame 21 or 28 days after last vaccine dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to < 5 years and with a baseline titre < 1:40 were analysed for this Outcome Measure.
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 384 405
Measure Type: Count of Participants
Unit of Measure: Participants
A/New Caledonia [6 to <36 months] Number Analyzed 190 participants 207 participants
125
  65.8%
117
  56.5%
A/Wisconsin [6 to <36 months] Number Analyzed 166 participants 179 participants
114
  68.7%
173
  96.6%
B/Malaysia [6 to <36 months] Number Analyzed 194 participants 211 participants
74
  38.1%
129
  61.1%
A/New Caledonia [3 to <5 years] Number Analyzed 182 participants 175 participants
163
  89.6%
155
  88.6%
A/Wisconsin [3 to <5 years] Number Analyzed 89 participants 98 participants
75
  84.3%
92
  93.9%
B/Malaysia [3 to <5 years] Number Analyzed 190 participants 194 participants
115
  60.5%
125
  64.4%
6.Secondary Outcome
Title Number of Subjects Reporting Solicited Local and General Symptoms
Hide Description

Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.

Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.

Time Frame During a 4-day follow-up period after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Analysis was performed on vaccinated subjects with available data.

  • Pain, redness, swelling and fever were assessed in all age cohorts.
  • Drowsiness, irritability and loss of appetite were assessed in the 6 months to < 5 years cohort only.
  • Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to < 18 years cohort only.
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 2039 1149
Measure Type: Count of Participants
Unit of Measure: Participants
Pain [Any] Number Analyzed 2039 participants 1149 participants
1072
  52.6%
526
  45.8%
Pain [Grade 3] Number Analyzed 2039 participants 1149 participants
31
   1.5%
19
   1.7%
Redness [Any] Number Analyzed 2039 participants 1149 participants
421
  20.6%
233
  20.3%
Redness [> 50 mm] Number Analyzed 2039 participants 1149 participants
16
   0.8%
4
   0.3%
Swelling [Any] Number Analyzed 2039 participants 1149 participants
308
  15.1%
152
  13.2%
Swelling [> 50 mm] Number Analyzed 2039 participants 1149 participants
22
   1.1%
4
   0.3%
Drowsiness [Any] Number Analyzed 691 participants 697 participants
160
  23.2%
177
  25.4%
Drowsiness [Grade 3] Number Analyzed 691 participants 697 participants
15
   2.2%
16
   2.3%
Drowsiness [Related] Number Analyzed 691 participants 697 participants
127
  18.4%
125
  17.9%
Fever [≥37.5°C] Number Analyzed 2039 participants 1148 participants
152
   7.5%
85
   7.4%
Fever [> 39°C] Number Analyzed 2039 participants 1148 participants
20
   1.0%
12
   1.0%
Fever [Related] Number Analyzed 2039 participants 1148 participants
69
   3.4%
48
   4.2%
Irritability [Any] Number Analyzed 691 participants 697 participants
232
  33.6%
246
  35.3%
Irritability [Grade 3] Number Analyzed 691 participants 697 participants
20
   2.9%
18
   2.6%
Irritability [Related] Number Analyzed 691 participants 697 participants
201
  29.1%
199
  28.6%
Loss of appetite [Any] Number Analyzed 691 participants 697 participants
131
  19.0%
128
  18.4%
Loss of appetite [Grade 3] Number Analyzed 691 participants 697 participants
9
   1.3%
13
   1.9%
Loss of appetite [Related] Number Analyzed 691 participants 697 participants
103
  14.9%
96
  13.8%
Arthralgia [Any] Number Analyzed 1348 participants 451 participants
85
   6.3%
30
   6.7%
Arthralgia [Grade 3] Number Analyzed 1348 participants 451 participants
2
   0.1%
1
   0.2%
Arthralgia [Related] Number Analyzed 1348 participants 451 participants
74
   5.5%
27
   6.0%
Fatigue [Any] Number Analyzed 1348 participants 451 participants
285
  21.1%
88
  19.5%
Fatigue [Grade 3] Number Analyzed 1348 participants 451 participants
15
   1.1%
6
   1.3%
Fatigue [Related] Number Analyzed 1348 participants 451 participants
225
  16.7%
72
  16.0%
Headache [Any] Number Analyzed 1348 participants 451 participants
218
  16.2%
76
  16.9%
Headache [Grade 3] Number Analyzed 1348 participants 451 participants
8
   0.6%
4
   0.9%
Headache [Related] Number Analyzed 1348 participants 451 participants
171
  12.7%
61
  13.5%
Muscle aches [Any] Number Analyzed 1348 participants 451 participants
410
  30.4%
133
  29.5%
Muscle aches [Grade 3] Number Analyzed 1348 participants 451 participants
6
   0.4%
3
   0.7%
Muscle aches [Related] Number Analyzed 1348 participants 451 participants
367
  27.2%
121
  26.8%
Shivering [Any] Number Analyzed 1348 participants 451 participants
45
   3.3%
17
   3.8%
Shivering [Grade 3] Number Analyzed 1348 participants 451 participants
2
   0.1%
1
   0.2%
Shivering [Related] Number Analyzed 1348 participants 451 participants
37
   2.7%
14
   3.1%
7.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description

An Adverse Event 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.

Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.

Time Frame Within 28 days following vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 2115 1210
Measure Type: Count of Participants
Unit of Measure: Participants
Any
700
  33.1%
458
  37.9%
Grade 3
102
   4.8%
62
   5.1%
Related
112
   5.3%
75
   6.2%
8.Secondary Outcome
Title Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)
Hide Description

SAE: any untoward medical occurrence that

  • resulted in death,
  • was life-threatening,
  • required hospitalization or prolongation of existing hospitalization,
  • resulted in disability/incapacity, or
  • was a congenital anomaly/birth defect in the offspring of a study subject.

Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.

Time Frame Up to 6 months after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description:

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Overall Number of Participants Analyzed 2115 1210
Measure Type: Count of Participants
Unit of Measure: Participants
New onset chronic illnesses
11
   0.5%
3
   0.2%
Serious adverse events
11
   0.5%
11
   0.9%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluarix Group Fluzone Group
Hide Arm/Group Description

Subjects in this group received Fluarix and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
All-Cause Mortality
Fluarix Group Fluzone Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Fluarix Group Fluzone Group
Affected / at Risk (%) Affected / at Risk (%)
Total   11   11 
Blood and lymphatic system disorders     
Lymphadenitis *  2/2115 (0.09%)  0/1210 (0.00%) 
Gastrointestinal disorders     
Faecaloma *  1/2115 (0.05%)  0/1210 (0.00%) 
Infections and infestations     
Appendicitis *  1/2115 (0.05%)  0/1210 (0.00%) 
Cellulitis *  1/2115 (0.05%)  1/1210 (0.08%) 
Gastroenteritis *  0/2115 (0.00%)  1/1210 (0.08%) 
Gastroenteritis viral *  0/2115 (0.00%)  1/1210 (0.08%) 
Infectious mononucleosis *  1/2115 (0.05%)  0/1210 (0.00%) 
Lobar pneumonia *  1/2115 (0.05%)  0/1210 (0.00%) 
Meningitis enteroviral *  0/2115 (0.00%)  1/1210 (0.08%) 
Pharyngitis streptococcal *  0/2115 (0.00%)  1/1210 (0.08%) 
Pneumonia *  1/2115 (0.05%)  2/1210 (0.17%) 
Pneumonia viral *  1/2115 (0.05%)  0/1210 (0.00%) 
Respiratory syncytial virus bronchiolitis *  1/2115 (0.05%)  0/1210 (0.00%) 
Salmonellosis *  1/2115 (0.05%)  0/1210 (0.00%) 
Injury, poisoning and procedural complications     
Traumatic brain injury *  1/2115 (0.05%)  0/1210 (0.00%) 
Metabolism and nutrition disorders     
Dehydration *  0/2115 (0.00%)  1/1210 (0.08%) 
Nervous system disorders     
Febrile convulsion *  1/2115 (0.05%)  2/1210 (0.17%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous *  1/2115 (0.05%)  0/1210 (0.00%) 
Psychiatric disorders     
Suicide attempt *  0/2115 (0.00%)  1/1210 (0.08%) 
Respiratory, thoracic and mediastinal disorders     
Asthma *  1/2115 (0.05%)  0/1210 (0.00%) 
Pneumomediastinum *  0/2115 (0.00%)  1/1210 (0.08%) 
Pneumothorax *  0/2115 (0.00%)  1/1210 (0.08%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Fluarix Group Fluzone Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1480/2115 (69.98%)   781/1210 (64.55%) 
General disorders     
Pyrexia *  102/2115 (4.82%)  86/1210 (7.11%) 
Pain at the injection site   1072/2115 (50.69%)  526/1210 (43.47%) 
Redness at the injection site   421/2115 (19.91%)  233/1210 (19.26%) 
Swelling at the injection site   308/2115 (14.56%)  152/1210 (12.56%) 
Drowsiness   160/2115 (7.57%)  177/1210 (14.63%) 
Axillary fever   152/2115 (7.19%)  85/1210 (7.02%) 
Irritability   232/2115 (10.97%)  246/1210 (20.33%) 
Loss of appetite   131/2115 (6.19%)  128/1210 (10.58%) 
Arthralgia   85/2115 (4.02%)  30/1210 (2.48%) 
Fatigue   285/2115 (13.48%)  88/1210 (7.27%) 
Headache   218/2115 (10.31%)  76/1210 (6.28%) 
Muscle aches   410/2115 (19.39%)  133/1210 (10.99%) 
Infections and infestations     
Upper respiratory tract infection *  116/2115 (5.48%)  74/1210 (6.12%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  100/2115 (4.73%)  81/1210 (6.69%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00383123     History of Changes
Other Study ID Numbers: 104858
First Submitted: September 29, 2006
First Posted: October 2, 2006
Results First Submitted: October 15, 2008
Results First Posted: December 4, 2008
Last Update Posted: June 8, 2018