Trial Outcomes & Findings for Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children (NCT NCT00383123)
NCT ID: NCT00383123
Last Updated: 2018-06-08
Results Overview
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3327 participants
Primary outcome timeframe
21 or 28 days after last vaccine dose
Results posted on
2018-06-08
Participant Flow
Two subjects, enrolled in the Fluzone Group, were not vaccinated; therefore, they were not included in the number of subjects included under "STARTED".
Participant milestones
| Measure |
Fluarix Group
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
|
Fluzone Group
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 Study
STARTED
|
2115
|
1210
|
|
Overall Study
COMPLETED
|
2004
|
1124
|
|
Overall Study
NOT COMPLETED
|
111
|
86
|
Reasons for withdrawal
| Measure |
Fluarix Group
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
|
Fluzone Group
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 Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
68
|
61
|
|
Overall Study
Protocol Violation
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
27
|
18
|
|
Overall Study
Other reason
|
10
|
6
|
Baseline Characteristics
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
Baseline characteristics by cohort
| Measure |
Fluarix Group
n=2115 Participants
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
|
Fluzone Group
n=1210 Participants
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
n=3325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.6 years
STANDARD_DEVIATION 4.97 • n=5 Participants
|
5.5 years
STANDARD_DEVIATION 4.75 • n=7 Participants
|
6.8 years
STANDARD_DEVIATION 4.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1038 Participants
n=5 Participants
|
586 Participants
n=7 Participants
|
1624 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1077 Participants
n=5 Participants
|
624 Participants
n=7 Participants
|
1701 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African heritage / african american
|
344 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
582 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American indian or alaskan native
|
78 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - central/south asian heritage
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - east asian heritage
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - japanese heritage
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - south east asian heritage
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native hawaiian or other pacific island
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - arabic / north african heritage
|
29 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - caucasian / european heritage
|
1477 Participants
n=5 Participants
|
794 Participants
n=7 Participants
|
2271 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
121 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 or 28 days after last vaccine dosePopulation: Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to \< 5 years).
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Outcome measures
| Measure |
Fluarix Group
n=426 Participants
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
|
Fluzone Group
n=445 Participants
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
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
A/New Caledonia [6 to <36 months]
|
52.4 Titer
Interval 43.3 to 63.4
|
101.4 Titer
Interval 86.9 to 118.2
|
|
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
A/Wisconsin [6 to <36 months]
|
80.5 Titer
Interval 62.2 to 104.1
|
218.0 Titer
Interval 185.8 to 255.8
|
|
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
B/Malaysia [6 to <36 months]
|
20.2 Titer
Interval 15.9 to 25.8
|
40.6 Titer
Interval 32.3 to 51.1
|
|
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
A/New Caledonia [3 to < 5 years]
|
130.3 Titer
Interval 108.6 to 156.4
|
168.7 Titer
Interval 138.7 to 205.2
|
|
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
A/Wisconsin [3 to < 5 years]
|
458.1 Titer
Interval 365.3 to 574.3
|
483.4 Titer
Interval 396.8 to 588.9
|
|
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
B/Malaysia [3 to < 5 years]
|
54.9 Titer
Interval 42.3 to 71.1
|
64.4 Titer
Interval 49.5 to 83.8
|
PRIMARY outcome
Timeframe: 21 or 28 days after last vaccine dosePopulation: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=425 Participants
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
|
Fluzone Group
n=443 Participants
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
|
|---|---|---|
|
Number of Seroconverted Subjects
A/New Caledonia [6 to <36 months]
|
105 Participants
|
179 Participants
|
|
Number of Seroconverted Subjects
A/Wisconsin [6 to <36 months]
|
117 Participants
|
190 Participants
|
|
Number of Seroconverted Subjects
B/Malaysia [6 to <36 months]
|
48 Participants
|
114 Participants
|
|
Number of Seroconverted Subjects
A/New Caledonia [3 to <5 years]
|
160 Participants
|
159 Participants
|
|
Number of Seroconverted Subjects
A/Wisconsin [3 to <5 years]
|
156 Participants
|
155 Participants
|
|
Number of Seroconverted Subjects
B/Malaysia [3 to <5 years]
|
117 Participants
|
122 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after vaccinationRare 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.
Outcome measures
| Measure |
Fluarix Group
n=2115 Participants
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
|
Fluzone Group
n=1210 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Rare Serious Events
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Before (PRE) and 21 or 28 days after (POST) the last vaccine dosePopulation: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=426 Participants
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
|
Fluzone Group
n=445 Participants
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
|
|---|---|---|
|
Number of Seroprotected Subjects
A/New Caledonia [6 to <36 months] PRE
|
15 Participants
|
16 Participants
|
|
Number of Seroprotected Subjects
A/New Caledonia [6 to <36 months] POST
|
122 Participants
|
193 Participants
|
|
Number of Seroprotected Subjects
A/Wisconsin [6 to <36 months] PRE
|
39 Participants
|
44 Participants
|
|
Number of Seroprotected Subjects
A/Wisconsin [6 to <36 months] POST
|
135 Participants
|
211 Participants
|
|
Number of Seroprotected Subjects
B/Malaysia [6 to <36 months] PRE
|
11 Participants
|
12 Participants
|
|
Number of Seroprotected Subjects
B/Malaysia [6 to <36 months] POST
|
50 Participants
|
115 Participants
|
|
Number of Seroprotected Subjects
A/New Caledonia [3 to <5 years] PRE
|
38 Participants
|
45 Participants
|
|
Number of Seroprotected Subjects
A/New Caledonia [3 to <5 years] POST
|
180 Participants
|
189 Participants
|
|
Number of Seroprotected Subjects
A/Wisconsin [3 to <5 years] PRE
|
131 Participants
|
122 Participants
|
|
Number of Seroprotected Subjects
A/Wisconsin [3 to <5 years] POST
|
194 Participants
|
207 Participants
|
|
Number of Seroprotected Subjects
B/Malaysia [3 to <5 years] PRE
|
30 Participants
|
26 Participants
|
|
Number of Seroprotected Subjects
B/Malaysia [3 to <5 years] POST
|
121 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: 21 or 28 days after last vaccine dosePopulation: 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.
Initially unprotected subjects are subjects with a baseline HI titer \< 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Outcome measures
| Measure |
Fluarix Group
n=384 Participants
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
|
Fluzone Group
n=405 Participants
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
|
|---|---|---|
|
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
A/New Caledonia [6 to <36 months]
|
125 Participants
|
117 Participants
|
|
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
A/Wisconsin [6 to <36 months]
|
114 Participants
|
173 Participants
|
|
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
B/Malaysia [6 to <36 months]
|
74 Participants
|
129 Participants
|
|
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
A/New Caledonia [3 to <5 years]
|
163 Participants
|
155 Participants
|
|
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
A/Wisconsin [3 to <5 years]
|
75 Participants
|
92 Participants
|
|
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
B/Malaysia [3 to <5 years]
|
115 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period after each vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=2039 Participants
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
|
Fluzone Group
n=1149 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Pain [Any]
|
1072 Participants
|
526 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Pain [Grade 3]
|
31 Participants
|
19 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Redness [Any]
|
421 Participants
|
233 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Redness [> 50 mm]
|
16 Participants
|
4 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Swelling [Any]
|
308 Participants
|
152 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Swelling [> 50 mm]
|
22 Participants
|
4 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Drowsiness [Any]
|
160 Participants
|
177 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Drowsiness [Grade 3]
|
15 Participants
|
16 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Drowsiness [Related]
|
127 Participants
|
125 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever [≥37.5°C]
|
152 Participants
|
85 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever [> 39°C]
|
20 Participants
|
12 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever [Related]
|
69 Participants
|
48 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Irritability [Any]
|
232 Participants
|
246 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Irritability [Grade 3]
|
20 Participants
|
18 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Irritability [Related]
|
201 Participants
|
199 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Loss of appetite [Any]
|
131 Participants
|
128 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Loss of appetite [Grade 3]
|
9 Participants
|
13 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Loss of appetite [Related]
|
103 Participants
|
96 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Arthralgia [Any]
|
85 Participants
|
30 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Arthralgia [Grade 3]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Arthralgia [Related]
|
74 Participants
|
27 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fatigue [Any]
|
285 Participants
|
88 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fatigue [Grade 3]
|
15 Participants
|
6 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fatigue [Related]
|
225 Participants
|
72 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Headache [Any]
|
218 Participants
|
76 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Headache [Grade 3]
|
8 Participants
|
4 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Headache [Related]
|
171 Participants
|
61 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Muscle aches [Any]
|
410 Participants
|
133 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Muscle aches [Grade 3]
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Muscle aches [Related]
|
367 Participants
|
121 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Shivering [Any]
|
45 Participants
|
17 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Shivering [Grade 3]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Shivering [Related]
|
37 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Within 28 days following vaccinationAn 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.
Outcome measures
| Measure |
Fluarix Group
n=2115 Participants
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
|
Fluzone Group
n=1210 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events
Any
|
700 Participants
|
458 Participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events
Grade 3
|
102 Participants
|
62 Participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events
Related
|
112 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after vaccinationSAE: 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.
Outcome measures
| Measure |
Fluarix Group
n=2115 Participants
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
|
Fluzone Group
n=1210 Participants
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
|
|---|---|---|
|
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)
New onset chronic illnesses
|
11 Participants
|
3 Participants
|
|
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)
Serious adverse events
|
11 Participants
|
11 Participants
|
Adverse Events
Fluarix Group
Serious events: 11 serious events
Other events: 1480 other events
Deaths: 0 deaths
Fluzone Group
Serious events: 11 serious events
Other events: 781 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluarix Group
n=2115 participants at risk
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
|
Fluzone Group
n=1210 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.09%
2/2115
|
0.00%
0/1210
|
|
Gastrointestinal disorders
Faecaloma
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Infections and infestations
Appendicitis
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Infections and infestations
Cellulitis
|
0.05%
1/2115
|
0.08%
1/1210
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2115
|
0.08%
1/1210
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2115
|
0.08%
1/1210
|
|
Infections and infestations
Infectious mononucleosis
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Infections and infestations
Lobar pneumonia
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Infections and infestations
Meningitis enteroviral
|
0.00%
0/2115
|
0.08%
1/1210
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/2115
|
0.08%
1/1210
|
|
Infections and infestations
Pneumonia
|
0.05%
1/2115
|
0.17%
2/1210
|
|
Infections and infestations
Pneumonia viral
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Infections and infestations
Salmonellosis
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2115
|
0.08%
1/1210
|
|
Nervous system disorders
Febrile convulsion
|
0.05%
1/2115
|
0.17%
2/1210
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/2115
|
0.08%
1/1210
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.05%
1/2115
|
0.00%
0/1210
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/2115
|
0.08%
1/1210
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2115
|
0.08%
1/1210
|
Other adverse events
| Measure |
Fluarix Group
n=2115 participants at risk
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
|
Fluzone Group
n=1210 participants at risk
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
|
|---|---|---|
|
General disorders
Pyrexia
|
4.8%
102/2115
|
7.1%
86/1210
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
116/2115
|
6.1%
74/1210
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
100/2115
|
6.7%
81/1210
|
|
General disorders
Pain at the injection site
|
50.7%
1072/2115
|
43.5%
526/1210
|
|
General disorders
Redness at the injection site
|
19.9%
421/2115
|
19.3%
233/1210
|
|
General disorders
Swelling at the injection site
|
14.6%
308/2115
|
12.6%
152/1210
|
|
General disorders
Drowsiness
|
7.6%
160/2115
|
14.6%
177/1210
|
|
General disorders
Axillary fever
|
7.2%
152/2115
|
7.0%
85/1210
|
|
General disorders
Irritability
|
11.0%
232/2115
|
20.3%
246/1210
|
|
General disorders
Loss of appetite
|
6.2%
131/2115
|
10.6%
128/1210
|
|
General disorders
Arthralgia
|
4.0%
85/2115
|
2.5%
30/1210
|
|
General disorders
Fatigue
|
13.5%
285/2115
|
7.3%
88/1210
|
|
General disorders
Headache
|
10.3%
218/2115
|
6.3%
76/1210
|
|
General disorders
Muscle aches
|
19.4%
410/2115
|
11.0%
133/1210
|
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