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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00383123
• Collaborator: (none)
• Enrollment: 3,327
• Locations: 40
• Arms: 2
• Duration (Months): 11.5
• Patients Per Site: 83.2
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Fluarix™; Biological: Fluzone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 3327 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)
• Study Start Date: Nov 2, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 19, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: Fluarix™; Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months. *Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.
Active Comparator: 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	Biological: Fluzone; Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months. *Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies [21 or 28 days after last vaccine dose]

   GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.

2. Number of Seroconverted Subjects [21 or 28 days after last vaccine dose]

   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.

3. Number of Subjects Reporting Rare Serious Events [Up to 6 months after vaccination]

   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.

Secondary Outcome Measures

1. Number of Seroprotected Subjects [Before (PRE) and 21 or 28 days after (POST) the last vaccine dose]

   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.

2. Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer [21 or 28 days after last vaccine dose]

   Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.

3. Number of Subjects Reporting Solicited Local and General Symptoms [During a 4-day follow-up period after each vaccination]

   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.

4. Number of Subjects Reporting Unsolicited Adverse Events [Within 28 days following vaccination]

   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.

5. Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) [Up to 6 months after vaccination]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.

• Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.

• Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.

• Female subjects of childbearing potential must agree to take a pregnancy test.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.

• History of hypersensitivity to any vaccine.

• History of allergy or reactions likely to be exacerbated by any component of the vaccine.

• Acute disease at the time of enrollment.

• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.

• Pregnant or lactating female.

• Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Antioch	California	United States	94509
2	GSK Investigational Site	Fairfield	California	United States	94533
3	GSK Investigational Site	Fresno	California	United States	93710
4	GSK Investigational Site	Pleasanton	California	United States	94588
5	GSK Investigational Site	Redwood City	California	United States	94063
6	GSK Investigational Site	Richmond	California	United States	94801
7	GSK Investigational Site	Rolling Hills Estates	California	United States	90274
8	GSK Investigational Site	Sacramento	California	United States	95815
9	GSK Investigational Site	San Francisco	California	United States	94102
10	GSK Investigational Site	San Francisco	California	United States	94115
11	GSK Investigational Site	Santa Clara	California	United States	95051
12	GSK Investigational Site	Santa Rosa	California	United States	95403
13	GSK Investigational Site	Vacaville	California	United States	95688
14	GSK Investigational Site	Vallejo	California	United States	94589
15	GSK Investigational Site	Walnut Creek	California	United States	94596
16	GSK Investigational Site	Englewood	Colorado	United States	80112
17	GSK Investigational Site	Lakewood	Colorado	United States	80401
18	GSK Investigational Site	Tifton	Georgia	United States	31794
19	GSK Investigational Site	Bardstown	Kentucky	United States	40004
20	GSK Investigational Site	Lexington	Kentucky	United States	40509
21	GSK Investigational Site	Metairie	Louisiana	United States	70006
22	GSK Investigational Site	Omaha	Nebraska	United States	68134
23	GSK Investigational Site	Whitehouse Station	New Jersey	United States	08889
24	GSK Investigational Site	Fishkill	New York	United States	12524
25	GSK Investigational Site	Hopewell Junction	New York	United States	12533
26	GSK Investigational Site	Poughkeepsie	New York	United States	12603
27	GSK Investigational Site	Rochester	New York	United States	14609
28	GSK Investigational Site	Rochester	New York	United States	14620
29	GSK Investigational Site	Cary	North Carolina	United States	27518
30	GSK Investigational Site	Sylva	North Carolina	United States	28779
31	GSK Investigational Site	Cleveland	Ohio	United States	44118
32	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15241
33	GSK Investigational Site	Uniontown	Pennsylvania	United States	15401
34	GSK Investigational Site	Austin	Texas	United States	78728
35	GSK Investigational Site	Fort Worth	Texas	United States	76135
36	GSK Investigational Site	San Angelo	Texas	United States	76904
37	GSK Investigational Site	Layton	Utah	United States	84041
38	GSK Investigational Site	Salt Lake City	Utah	United States	84121
39	GSK Investigational Site	South Jordan	Utah	United States	84095
40	GSK Investigational Site	West Jordan	Utah	United States	84084

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00383123
• Other Study ID Numbers: 104858
• First Posted: Oct 2, 2006
• Last Update Posted: Jun 8, 2018
• Last Verified: Nov 1, 2016

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

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Fluarix Group	Fluzone Group	Total
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 Participants	2115	1210	3325
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.6 (4.97)	5.5 (4.75)	6.8 (4.99)
Sex: Female, Male (Count of Participants)
Female	1038 49.1%	586 48.4%	1624 48.8%
Male	1077 50.9%	624 51.6%	1701 51.2%
Race/Ethnicity, Customized (Count of 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%	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%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
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

Outcome Measure Data

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
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
Measure Participants	426	445
A/New Caledonia [6 to <36 months]	52.4	101.4
A/Wisconsin [6 to <36 months]	80.5	218.0
B/Malaysia [6 to <36 months]	20.2	40.6
A/New Caledonia [3 to < 5 years]	130.3	168.7
A/Wisconsin [3 to < 5 years]	458.1	483.4
B/Malaysia [3 to < 5 years]	54.9	64.4

2. Primary Outcome

Title	Number of Seroconverted Subjects
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

Outcome Measure Data

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
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
Measure Participants	425	443
A/New Caledonia [6 to <36 months]	105 5%	179 14.8%
A/Wisconsin [6 to <36 months]	117 5.5%	190 15.7%
B/Malaysia [6 to <36 months]	48 2.3%	114 9.4%
A/New Caledonia [3 to <5 years]	160 7.6%	159 13.1%
A/Wisconsin [3 to <5 years]	156 7.4%	155 12.8%
B/Malaysia [3 to <5 years]	117 5.5%	122 10.1%

3. Primary Outcome

Title	Number of Subjects Reporting Rare Serious Events
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluarix Group	Fluzone Group
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
Measure Participants	2115	1210
Count of Participants [Participants]	11 0.5%	11 0.9%

4. Secondary Outcome

Title	Number of Seroprotected Subjects
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

Outcome Measure Data

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
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
Measure Participants	426	445
A/New Caledonia [6 to <36 months] PRE	15 0.7%	16 1.3%
A/New Caledonia [6 to <36 months] POST	122 5.8%	193 16%
A/Wisconsin [6 to <36 months] PRE	39 1.8%	44 3.6%
A/Wisconsin [6 to <36 months] POST	135 6.4%	211 17.4%
B/Malaysia [6 to <36 months] PRE	11 0.5%	12 1%
B/Malaysia [6 to <36 months] POST	50 2.4%	115 9.5%
A/New Caledonia [3 to <5 years] PRE	38 1.8%	45 3.7%
A/New Caledonia [3 to <5 years] POST	180 8.5%	189 15.6%
A/Wisconsin [3 to <5 years] PRE	131 6.2%	122 10.1%
A/Wisconsin [3 to <5 years] POST	194 9.2%	207 17.1%
B/Malaysia [3 to <5 years] PRE	30 1.4%	26 2.1%
B/Malaysia [3 to <5 years] POST	121 5.7%	129 10.7%

5. Secondary Outcome

Title	Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
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

Outcome Measure Data

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
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
Measure Participants	384	405
A/New Caledonia [6 to <36 months]	125 5.9%	117 9.7%
A/Wisconsin [6 to <36 months]	114 5.4%	173 14.3%
B/Malaysia [6 to <36 months]	74 3.5%	129 10.7%
A/New Caledonia [3 to <5 years]	163 7.7%	155 12.8%
A/Wisconsin [3 to <5 years]	75 3.5%	92 7.6%
B/Malaysia [3 to <5 years]	115 5.4%	125 10.3%

6. Secondary Outcome

Title	Number of Subjects Reporting Solicited Local and General Symptoms
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

Outcome Measure Data

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
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
Measure Participants	2039	1149
Pain [Any]	1072 50.7%	526 43.5%
Pain [Grade 3]	31 1.5%	19 1.6%
Redness [Any]	421 19.9%	233 19.3%
Redness [> 50 mm]	16 0.8%	4 0.3%
Swelling [Any]	308 14.6%	152 12.6%
Swelling [> 50 mm]	22 1%	4 0.3%
Drowsiness [Any]	160 7.6%	177 14.6%
Drowsiness [Grade 3]	15 0.7%	16 1.3%
Drowsiness [Related]	127 6%	125 10.3%
Fever [≥37.5°C]	152 7.2%	85 7%
Fever [> 39°C]	20 0.9%	12 1%
Fever [Related]	69 3.3%	48 4%
Irritability [Any]	232 11%	246 20.3%
Irritability [Grade 3]	20 0.9%	18 1.5%
Irritability [Related]	201 9.5%	199 16.4%
Loss of appetite [Any]	131 6.2%	128 10.6%
Loss of appetite [Grade 3]	9 0.4%	13 1.1%
Loss of appetite [Related]	103 4.9%	96 7.9%
Arthralgia [Any]	85 4%	30 2.5%
Arthralgia [Grade 3]	2 0.1%	1 0.1%
Arthralgia [Related]	74 3.5%	27 2.2%
Fatigue [Any]	285 13.5%	88 7.3%
Fatigue [Grade 3]	15 0.7%	6 0.5%
Fatigue [Related]	225 10.6%	72 6%
Headache [Any]	218 10.3%	76 6.3%
Headache [Grade 3]	8 0.4%	4 0.3%
Headache [Related]	171 8.1%	61 5%
Muscle aches [Any]	410 19.4%	133 11%
Muscle aches [Grade 3]	6 0.3%	3 0.2%
Muscle aches [Related]	367 17.4%	121 10%
Shivering [Any]	45 2.1%	17 1.4%
Shivering [Grade 3]	2 0.1%	1 0.1%
Shivering [Related]	37 1.7%	14 1.2%

7. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluarix Group	Fluzone Group
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
Measure Participants	2115	1210
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluarix Group	Fluzone Group
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
Measure Participants	2115	1210
New onset chronic illnesses	11 0.5%	3 0.2%
Serious adverse events	11 0.5%	11 0.9%

Adverse Events

Arm/Group Title	Fluarix Group		Fluzone Group
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Fluarix Group		Fluzone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/ (NaN)		11/ (NaN)
Blood and lymphatic system disorders
Lymphadenitis	2/2115 (0.1%)		0/1210 (0%)
Gastrointestinal disorders
Faecaloma	1/2115 (0%)		0/1210 (0%)
Infections and infestations
Appendicitis	1/2115 (0%)		0/1210 (0%)
Cellulitis	1/2115 (0%)		1/1210 (0.1%)
Gastroenteritis	0/2115 (0%)		1/1210 (0.1%)
Gastroenteritis viral	0/2115 (0%)		1/1210 (0.1%)
Infectious mononucleosis	1/2115 (0%)		0/1210 (0%)
Lobar pneumonia	1/2115 (0%)		0/1210 (0%)
Meningitis enteroviral	0/2115 (0%)		1/1210 (0.1%)
Pharyngitis streptococcal	0/2115 (0%)		1/1210 (0.1%)
Pneumonia	1/2115 (0%)		2/1210 (0.2%)
Pneumonia viral	1/2115 (0%)		0/1210 (0%)
Respiratory syncytial virus bronchiolitis	1/2115 (0%)		0/1210 (0%)
Salmonellosis	1/2115 (0%)		0/1210 (0%)
Injury, poisoning and procedural complications
Traumatic brain injury	1/2115 (0%)		0/1210 (0%)
Metabolism and nutrition disorders
Dehydration	0/2115 (0%)		1/1210 (0.1%)
Nervous system disorders
Febrile convulsion	1/2115 (0%)		2/1210 (0.2%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/2115 (0%)		0/1210 (0%)
Psychiatric disorders
Suicide attempt	0/2115 (0%)		1/1210 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/2115 (0%)		0/1210 (0%)
Pneumomediastinum	0/2115 (0%)		1/1210 (0.1%)
Pneumothorax	0/2115 (0%)		1/1210 (0.1%)
Other (Not Including Serious) Adverse Events
	Fluarix Group		Fluzone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1480/2115 (70%)		781/1210 (64.5%)
General disorders
Pyrexia	102/2115 (4.8%)		86/1210 (7.1%)
Pain at the injection site	1072/2115 (50.7%)		526/1210 (43.5%)
Redness at the injection site	421/2115 (19.9%)		233/1210 (19.3%)
Swelling at the injection site	308/2115 (14.6%)		152/1210 (12.6%)
Drowsiness	160/2115 (7.6%)		177/1210 (14.6%)
Axillary fever	152/2115 (7.2%)		85/1210 (7%)
Irritability	232/2115 (11%)		246/1210 (20.3%)
Loss of appetite	131/2115 (6.2%)		128/1210 (10.6%)
Arthralgia	85/2115 (4%)		30/1210 (2.5%)
Fatigue	285/2115 (13.5%)		88/1210 (7.3%)
Headache	218/2115 (10.3%)		76/1210 (6.3%)
Muscle aches	410/2115 (19.4%)		133/1210 (11%)
Infections and infestations
Upper respiratory tract infection	116/2115 (5.5%)		74/1210 (6.1%)
Respiratory, thoracic and mediastinal disorders
Cough	100/2115 (4.7%)		81/1210 (6.7%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

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