Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00764790
• Collaborator: (none)
• Enrollment: 3,317
• Locations: 69
• Arms: 3
• Duration (Months): 8
• Patients Per Site: 48.1
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 3317 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Mar 5, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluarix Dose A Group Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Biological: Fluarix; One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Experimental: Fluarix Dose B Group Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Biological: Fluarix; One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Active Comparator: Fluzone Group Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Biological: Fluzone; One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains [Day 0 (PRE), Day 28 or Day 56 (POST)]

   GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

2. Number of Subjects Who Seroconverted [Day 28 or Day 56]

   Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA 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. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

Secondary Outcome Measures

1. Number of Seroprotected Subjects [Day 0 (PRE), Day 28 or Day 56 (POST)]

   A seroprotected subject is a subject with a serum anti-HA titer ≥ 1:40 Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

2. Seroconversion Factor [Day 28 or Day 56]

   Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0). Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

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

   Solicited local symptoms assessed include pain, redness and swelling.

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

   Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.

5. Number of Subjects Reporting Unsolicited Adverse Events (AE) [During a 28-day follow-up period after vaccination]

   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

6. Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD) [During the entire study (Day 0 until Month 6)]

   An 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. NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders

7. Number of Subjects Reporting Rare Serious Events [During the entire study (Day 0 until Month 6)]

   Rare serious events have an occurrence rate of 1/300 (0.3%).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 35 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A male or female child aged 6 to 35 months at the time of the first 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.

• Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or 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 criterion.

• 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 enrolment.

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

• Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.

• Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35205
2	GSK Investigational Site	Birmingham	Alabama	United States	35244
3	GSK Investigational Site	Dothan	Alabama	United States	36305
4	GSK Investigational Site	Benton	Arkansas	United States	72019
5	GSK Investigational Site	Conway	Arkansas	United States	72034
6	GSK Investigational Site	Fayetteville	Arkansas	United States	72703
7	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
8	GSK Investigational Site	Little Rock	Arkansas	United States	72205
9	GSK Investigational Site	Huntington Beach	California	United States	92647
10	GSK Investigational Site	Long Beach	California	United States	90806
11	GSK Investigational Site	Paramount	California	United States	90723
12	GSK Investigational Site	Sacramento	California	United States	95816
13	GSK Investigational Site	San Francisco	California	United States	94102
14	GSK Investigational Site	West Covina	California	United States	91790
15	GSK Investigational Site	Longmont	Colorado	United States	80501
16	GSK Investigational Site	Norwich	Connecticut	United States	06360
17	GSK Investigational Site	Nampa	Idaho	United States	83686
18	GSK Investigational Site	DeKalb	Illinois	United States	60115
19	GSK Investigational Site	New Albany	Indiana	United States	47150
20	GSK Investigational Site	Arkansas City	Kansas	United States	67005
21	GSK Investigational Site	Newton	Kansas	United States	67114
22	GSK Investigational Site	Wichita	Kansas	United States	67207
23	GSK Investigational Site	Bardstown	Kentucky	United States	40004
24	GSK Investigational Site	Louisville	Kentucky	United States	40207
25	GSK Investigational Site	Bossier City	Louisiana	United States	71111
26	GSK Investigational Site	Metairie	Louisiana	United States	70006
27	GSK Investigational Site	Stevensville	Michigan	United States	49127
28	GSK Investigational Site	Saint Paul	Minnesota	United States	55108
29	GSK Investigational Site	Saint Louis	Missouri	United States	63141
30	GSK Investigational Site	Omaha	Nebraska	United States	68134
31	GSK Investigational Site	Henderson	Nevada	United States	89015
32	GSK Investigational Site	Cortland	New York	United States	13045
33	GSK Investigational Site	Boone	North Carolina	United States	28607
34	GSK Investigational Site	Cary	North Carolina	United States	27518
35	GSK Investigational Site	Raleigh	North Carolina	United States	27609
36	GSK Investigational Site	Fargo	North Dakota	United States	58103
37	GSK Investigational Site	Austintown	Ohio	United States	44515
38	GSK Investigational Site	Cincinnati	Ohio	United States	45245
39	GSK Investigational Site	Cleveland	Ohio	United States	44121
40	GSK Investigational Site	Dayton	Ohio	United States	45406
41	GSK Investigational Site	Gresham	Oregon	United States	97030
42	GSK Investigational Site	Erie	Pennsylvania	United States	16505
43	GSK Investigational Site	Greenville	Pennsylvania	United States	16125
44	GSK Investigational Site	Latrobe	Pennsylvania	United States	15650
45	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15236
46	GSK Investigational Site	Uniontown	Pennsylvania	United States	15401
47	GSK Investigational Site	Wexford	Pennsylvania	United States	15090
48	GSK Investigational Site	Charleston	South Carolina	United States	29406
49	GSK Investigational Site	Clarksville	Tennessee	United States	37043
50	GSK Investigational Site	Jackson	Tennessee	United States	38305
51	GSK Investigational Site	Kingsport	Tennessee	United States	37660
52	GSK Investigational Site	Austin	Texas	United States	78705
53	GSK Investigational Site	Fort Worth	Texas	United States	76135
54	GSK Investigational Site	Houston	Texas	United States	77055
55	GSK Investigational Site	San Angelo	Texas	United States	76904
56	GSK Investigational Site	Bountiful	Utah	United States	84010
57	GSK Investigational Site	Layton	Utah	United States	84041
58	GSK Investigational Site	Murray	Utah	United States	84107
59	GSK Investigational Site	Provo	Utah	United States	84604
60	GSK Investigational Site	Roy	Utah	United States	84067
61	GSK Investigational Site	South Jordan	Utah	United States	84095
62	GSK Investigational Site	Burke	Virginia	United States	22015
63	GSK Investigational Site	Pokfulam		Hong Kong
64	GSK Investigational Site	Shatin		Hong Kong
65	GSK Investigational Site	Mexico city		Mexico	04530
66	GSK Investigational Site	Mexico		Mexico	6720
67	GSK Investigational Site	Taipei		Taiwan	104
68	GSK Investigational Site	Taipei		Taiwan
69	GSK Investigational Site	Bangkok		Thailand	10400

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: NCT00764790
• Other Study ID Numbers: 111751
• First Posted: Oct 2, 2008
• Last Update Posted: Jul 31, 2018
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Period Title: Overall Study
STARTED	1107	1106	1104
COMPLETED	1069	1065	1074
NOT COMPLETED	38	41	30

Baseline Characteristics

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group	Total
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Total of all reporting groups
Overall Participants	1107	1106	1104	3317
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	20.9 (8.07)	20.9 (8.42)	21.0 (8.23)	20.9 (8.24)
Sex: Female, Male (Count of Participants)
Female	539 48.7%	517 46.7%	560 50.7%	1616 48.7%
Male	568 51.3%	589 53.3%	544 49.3%	1701 51.3%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
Description	GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Time Frame	Day 0 (PRE), Day 28 or Day 56 (POST)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1018	1016	1031
A/Brisbane (PRE)	10.4	10.6	10.9
A/Brisbane (POST)	106.1	131.6	232.4
A/Uruguay (PRE)	12.1	11.2	11.6
A/Uruguay (POST)	125.6	158.7	280.3
B/Florida (PRE)	8.4	8.9	8.3
B/Florida (POST)	113.0	164.4	176.4

2. Primary Outcome

Title	Number of Subjects Who Seroconverted
Description	Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA 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. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Time Frame	Day 28 or Day 56

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ATP cohort for analysis of immunogenicity

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1017	1013	1030
A/Brisbane	636 57.5%	699 63.2%	929 84.1%
A/Uruguay	747 67.5%	808 73.1%	988 89.5%
B/Florida	812 73.4%	864 78.1%	904 81.9%

3. Secondary Outcome

Title	Number of Seroprotected Subjects
Description	A seroprotected subject is a subject with a serum anti-HA titer ≥ 1:40 Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Time Frame	Day 0 (PRE), Day 28 or Day 56 (POST)

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ATP cohort for analysis of immunogenicity

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1018	1016	1031
A/Brisbane (PRE)	185 16.7%	186 16.8%	206 18.7%
A/Brisbane (POST)	699 63.1%	754 68.2%	986 89.3%
A/Uruguay (PRE)	222 20.1%	193 17.5%	214 19.4%
A/Uruguay (POST)	788 71.2%	846 76.5%	1012 91.7%
B/Florida (PRE)	171 15.4%	181 16.4%	166 15%
B/Florida (POST)	872 78.8%	902 81.6%	935 84.7%

4. Secondary Outcome

Title	Seroconversion Factor
Description	Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0). Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Time Frame	Day 28 or Day 56

Outcome Measure Data

Analysis Population Description

Analysis was performed on the ATP cohort for analysis of immunogenicity

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1017	1013	1030
A/Brisbane	10.2	12.4	21.4
A/Uruguay	10.4	14.2	24.1
B/Florida	13.4	18.4	21.4

5. Secondary Outcome

Title	Number of Subjects Reporting Solicited Local Symptoms
Description	Solicited local symptoms assessed include pain, redness and swelling.
Time Frame	During a 4-day follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1081	1086	1090
Pain	403 36.4%	406 36.7%	363 32.9%
Redness	259 23.4%	249 22.5%	253 22.9%
Swelling	152 13.7%	170 15.4%	129 11.7%

6. Secondary Outcome

Title	Number of Subjects Reporting Solicited General Symptoms
Description	Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.
Time Frame	During a 4-day follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1080	1086	1090
Drowsiness	293 26.5%	317 28.7%	298 27%
Irritability	386 34.9%	387 35%	375 34%
Loss of appetite	281 25.4%	273 24.7%	270 24.5%
Temperature	67 6.1%	69 6.2%	72 6.5%

7. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events (AE)
Description	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
Time Frame	During a 28-day follow-up period after vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1107	1106	1104
Count of Participants [Participants]	565 51%	541 48.9%	562 50.9%

8. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)
Description	An 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. NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders
Time Frame	During the entire study (Day 0 until Month 6)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1107	1106	1104
SAE	35 3.2%	29 2.6%	31 2.8%
NOCD	10 0.9%	8 0.7%	9 0.8%

9. Secondary Outcome

Title	Number of Subjects Reporting Rare Serious Events
Description	Rare serious events have an occurrence rate of 1/300 (0.3%).
Time Frame	During the entire study (Day 0 until Month 6)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluarix Dose A Group	Fluarix Dose B Group	Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Measure Participants	1107	1106	1104
Pneumonia	0 0%	0 0%	3 0.3%
Bronchiolitis	0 0%	3 0.3%	3 0.3%

Adverse Events

Arm/Group Title	Fluarix Dose A Group		Fluarix Dose B Group		Fluzone Group
Arm/Group Description	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.		Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.		Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
All Cause Mortality
	Fluarix Dose A Group		Fluarix Dose B Group		Fluzone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluarix Dose A Group		Fluarix Dose B Group		Fluzone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/1107 (3.2%)		29/1106 (2.6%)		31/1104 (2.8%)
Blood and lymphatic system disorders
Neutropenia	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Thrombocytopenia	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Cardiac disorders
Cyanosis	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Congenital, familial and genetic disorders
Coarctation of the aorta	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Gastrointestinal disorders
Enterocolitis	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Gastritis	2/1107 (0.2%)		0/1106 (0%)		0/1104 (0%)
Haematochezia	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Intussusception	0/1107 (0%)		2/1106 (0.2%)		0/1104 (0%)
Vomiting	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
General disorders
Adverse drug reaction	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Infections and infestations
Acute sinusitis	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Acute tonsillitis	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Bronchiolitis	4/1107 (0.4%)		3/1106 (0.3%)		3/1104 (0.3%)
Bronchitis	1/1107 (0.1%)		2/1106 (0.2%)		1/1104 (0.1%)
Bronchopneumonia	0/1107 (0%)		1/1106 (0.1%)		1/1104 (0.1%)
Clostridium difficile colitis	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Croup infectious	1/1107 (0.1%)		1/1106 (0.1%)		0/1104 (0%)
Gastroenteritis	6/1107 (0.5%)		4/1106 (0.4%)		2/1104 (0.2%)
Gastroenteritis norovirus	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Gastroenteritis rotavirus	2/1107 (0.2%)		0/1106 (0%)		4/1104 (0.4%)
Herpes simplex	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Influenza	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Lobar pneumonia	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Oral herpes	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Otitis media	1/1107 (0.1%)		0/1106 (0%)		1/1104 (0.1%)
Otitis media acute	0/1107 (0%)		0/1106 (0%)		2/1104 (0.2%)
Pharyngitis	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Pharyngotonsillitis	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Pneumonia	4/1107 (0.4%)		4/1106 (0.4%)		3/1104 (0.3%)
Pneumonia pneumococcal	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Pneumonia primary atypical	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Pneumonia respiratory syncytial viral	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Pneumonia viral	1/1107 (0.1%)		1/1106 (0.1%)		0/1104 (0%)
Respiratory syncytial virus bronchiolitis	0/1107 (0%)		0/1106 (0%)		2/1104 (0.2%)
Respiratory syncytial virus infection	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Tonsillitis	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Upper respiratory tract infection	7/1107 (0.6%)		4/1106 (0.4%)		4/1104 (0.4%)
Urinary tract infection	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Viral rash	0/1107 (0%)		0/1106 (0%)		2/1104 (0.2%)
Viral upper respiratory tract infection	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Injury, poisoning and procedural complications
Concussion	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Electric shock	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Fall	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Femur fracture	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Foreign body trauma	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Head injury	1/1107 (0.1%)		1/1106 (0.1%)		0/1104 (0%)
Injury corneal	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Overdose	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Skull fracture	2/1107 (0.2%)		0/1106 (0%)		0/1104 (0%)
Thermal burn	0/1107 (0%)		0/1106 (0%)		2/1104 (0.2%)
Metabolism and nutrition disorders
Dehydration	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Hyponatraemia	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Nervous system disorders
Convulsion	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Febrile convulsion	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Psychiatric disorders
Mental status changes	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Respiratory, thoracic and mediastinal disorders
Apnoea	0/1107 (0%)		1/1106 (0.1%)		0/1104 (0%)
Asthma	2/1107 (0.2%)		1/1106 (0.1%)		2/1104 (0.2%)
Asthmatic crisis	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Bronchial hyperreactivity	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Hypoxia	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Pneumonitis	1/1107 (0.1%)		0/1106 (0%)		0/1104 (0%)
Skin and subcutaneous tissue disorders
Eczema	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Idiopathic urticaria	0/1107 (0%)		0/1106 (0%)		1/1104 (0.1%)
Other (Not Including Serious) Adverse Events
	Fluarix Dose A Group		Fluarix Dose B Group		Fluzone Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	805/1107 (72.7%)		791/1106 (71.5%)		808/1104 (73.2%)
Gastrointestinal disorders
Diarrhoea	62/1107 (5.6%)		42/1106 (3.8%)		60/1104 (5.4%)
General disorders
Pyrexia	53/1107 (4.8%)		52/1106 (4.7%)		62/1104 (5.6%)
Pain	403/1107 (36.4%)		406/1106 (36.7%)		363/1104 (32.9%)
Redness	259/1107 (23.4%)		249/1106 (22.5%)		253/1104 (22.9%)
Swelling	152/1107 (13.7%)		170/1106 (15.4%)		129/1104 (11.7%)
Drowsiness	293/1107 (26.5%)		317/1106 (28.7%)		298/1104 (27%)
Irritability	386/1107 (34.9%)		387/1106 (35%)		375/1104 (34%)
Loss of appetite	281/1107 (25.4%)		273/1106 (24.7%)		270/1104 (24.5%)
Temperature	67/1107 (6.1%)		69/1106 (6.2%)		72/1104 (6.5%)
Infections and infestations
Upper respiratory tract infection	135/1107 (12.2%)		116/1106 (10.5%)		139/1104 (12.6%)
Nasopharyngitis	139/1107 (12.6%)		119/1106 (10.8%)		123/1104 (11.1%)
Pharyngitis	49/1107 (4.4%)		60/1106 (5.4%)		52/1104 (4.7%)
Respiratory, thoracic and mediastinal disorders
Cough	59/1107 (5.3%)		70/1106 (6.3%)		60/1104 (5.4%)

Limitations/Caveats

[Not Specified]

More Information

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.