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Trial record 3 of 28 for:    pandemrix

Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™

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: NCT01196026
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : June 28, 2012
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Fluarix™
Biological: Havrix™ Junior
Enrollment 162

Recruitment Details

Primed subjects =subjects who had been previously vaccinated with a seasonal influenza vaccine whereas unprimed subjects had not.

  • children ≥ 9 years + primed children < 9 years=1 dose of Fluarix
  • unprimed children < 9 years=2 doses of Fluarix. To complete the vaccination schedule, a 2nd dose of Havrix vaccine was given outside the study setting
Pre-assignment Details 162 subjects were enrolled in the study but only 154 subjects were vaccinated. The remaining 8 subjects gave their consent withdrawal and were not included in the study.Enrollment was stratified according to the age at first Pandemrix vaccination: 6-11 months, 12-35 months, 3-9 years. Also, subjects were grouped from 3-5 and from 6-9 years.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Period Title: Overall Study
Started 10 44 23 10 43 24
Completed at Day 28 9 41 23 10 42 24
Completed 9 36 23 10 42 24
Not Completed 1 8 0 0 1 0
Reason Not Completed
Withdrawal by Subject             1             4             0             0             0             0
Lost to Follow-up             0             3             0             0             1             0
Other             0             1             0             0             0             0
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Total
Hide Arm/Group Description Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine. Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. Total of all reporting groups
Overall Number of Baseline Participants 10 44 23 10 43 24 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 44 participants 23 participants 10 participants 43 participants 24 participants 154 participants
1.0  (0.00) 2.3  (0.52) 6.4  (1.99) 1.0  (0.00) 2.4  (0.58) 7.5  (1.53) 3.58  (2.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 44 participants 23 participants 10 participants 43 participants 24 participants 154 participants
Female
5
  50.0%
21
  47.7%
13
  56.5%
4
  40.0%
16
  37.2%
13
  54.2%
72
  46.8%
Male
5
  50.0%
23
  52.3%
10
  43.5%
6
  60.0%
27
  62.8%
11
  45.8%
82
  53.2%
1.Primary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Hide Description Antibody titers were expressed as Geometric mean titers (GMTs).
Time Frame Day 0 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Overall Number of Participants Analyzed 0 0 0 0 0 0 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
120.7
(100.8 to 144.4)
Day 28
1079.3
(915.8 to 1272.0)
2.Primary Outcome
Title Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Hide Description Seropositivity was defined as antibody titers greater than or equal to 1:10.
Time Frame Day 0-28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Overall Number of Participants Analyzed 0 0 0 0 0 0 65
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0
65
 100.0%
Day 28
65
 100.0%
3.Primary Outcome
Title Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Hide Description A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Time Frame Day 0-28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Overall Number of Participants Analyzed 0 0 0 0 0 0 65
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0
63
  96.9%
Day 28
65
 100.0%
4.Primary Outcome
Title Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Hide Description A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Overall Number of Participants Analyzed 0 0 0 0 0 0 65
Measure Type: Count of Participants
Unit of Measure: Participants
55
  84.6%
5.Primary Outcome
Title Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Hide Description MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Overall Number of Participants Analyzed 0 0 0 0 0 0 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
8.9
(7.1 to 11.2)
6.Secondary Outcome
Title HI Antibody Titers Against All Fluarix Vaccine Strains
Hide Description Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.
Time Frame Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 35 23 10 43 24 65 77
Mean (95% Confidence Interval)
Unit of Measure: titer
H1N1 Day 0
176.6
(79.3 to 393.4)
124.9
(97.1 to 160.5)
102.0
(77.2 to 134.9)
171.4
(118.9 to 247.2)
186.5
(148.8 to 233.8)
105.3
(75.4 to 147.0)
120.7
(100.8 to 144.4)
154.4
(129.8 to 183.7)
H1N1 Day 28
1810.2
(775.2 to 4226.8)
1345.0
(1141.9 to 1584.1)
659.7
(524.1 to 830.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
1079.3
(915.8 to 1272.0)
NA [1] 
(NA to NA)
Victoria Day 0
16.4
(3.7 to 71.9)
15.1
(10.6 to 21.5)
21.9
(14.0 to 34.1)
13.6
(7.6 to 24.6)
19.1
(14.4 to 25.4)
19.1
(12.3 to 29.6)
17.4
(13.2 to 22.8)
18.3
(14.8 to 22.7)
Victoria Day 28
176.8
(28.1 to 1111.2)
142.2
(93.5 to 216.2)
188.8
(103.7 to 343.8)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
160.9
(115.0 to 225.2)
NA [1] 
(NA to NA)
H3N2 Day 0
5.0
(5.0 to 5.0)
21.2
(13.7 to 32.8)
31.0
(19.0 to 50.5)
5.0
(5.0 to 5.0)
8.9
(6.4 to 12.4)
26.7
(16.6 to 42.9)
20.8
(15.2 to 28.3)
11.7
(8.9 to 15.2)
H3N2 Day 28
88.4
(35.9 to 217.6)
448.3
(265.9 to 755.8)
518.6
(304.1 to 884.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
396.3
(276.3 to 568.5)
NA [1] 
(NA to NA)
[1]
Data not planned to be collected at Day 28, but rather at Month 6.
7.Secondary Outcome
Title HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Time Frame Day 0 and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
H1N1 Day 0
201.6
(81.1 to 501.1)
126.4
(93.2 to 171.4)
96.9
(73.9 to 126.9)
172.8
(113.9 to 262.1)
195.6
(155.1 to 246.6)
100.3
(71.8 to 140.1)
119.7
(97.9 to 146.3)
154.6
(128.8 to 185.5)
H1N1 Month 6
1437.0
(595.7 to 3466.6)
565.5
(458.1 to 698.2)
335.5
(253.1 to 444.7)
93.4
(48.6 to 179.5)
172.0
(127.9 to 231.4)
74.3
(55.4 to 99.6)
509.0
(416.9 to 621.5)
120.7
(97.2 to 149.8)
Victoria Day 0
17.8
(2.9 to 110.0)
16.2
(10.6 to 24.6)
21.6
(13.6 to 34.5)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
18.3
(13.5 to 24.8)
NA [1] 
(NA to NA)
Victoria Month 6
302.0
(115.6 to 788.8)
148.4
(97.9 to 225.1)
134.5
(82.2 to 220.1)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
154.1
(115.3 to 205.9)
NA [1] 
(NA to NA)
H3N2 Day 0
5.0
(5.0 to 5.0)
20.3
(12.4 to 33.0)
29.7
(17.9 to 49.2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
20.3
(14.5 to 28.2)
NA [1] 
(NA to NA)
H3N2 Month 6
127.0
(70.1 to 230.0)
160.0
(119.1 to 214.8)
252.7
(186.3 to 342.8)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
186.8
(152.9 to 228.2)
NA [1] 
(NA to NA)
[1]
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
8.Secondary Outcome
Title Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
Hide Description Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Time Frame Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 35 23 10 43 24 65 77
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Day 0
7
 100.0%
35
 100.0%
23
 100.0%
10
 100.0%
43
 100.0%
24
 100.0%
65
 100.0%
77
 100.0%
H1N1 Day 28
7
 100.0%
35
 100.0%
23
 100.0%
NA [1]  NA [1]  NA [1] 
65
 100.0%
NA [1] 
Victoria Day 0
4
  57.1%
25
  71.4%
20
  87.0%
9
  90.0%
39
  90.7%
20
  83.3%
49
  75.4%
68
  88.3%
Victoria Day 28
7
 100.0%
35
 100.0%
23
 100.0%
NA [1]  NA [1]  NA [1] 
65
 100.0%
NA [1] 
H3N2 Day 0
0
   0.0%
22
  62.9%
19
  82.6%
0
   0.0%
11
  25.6%
19
  79.2%
41
  63.1%
30
  39.0%
H3N2 Day 28
7
 100.0%
35
 100.0%
23
 100.0%
NA [1]  NA [1]  NA [1] 
65
 100.0%
NA [1] 
[1]
Data not planned to be collected at Day 28, but rather at Month 6.
9.Secondary Outcome
Title Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Time Frame Day 0 and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Day 0
6
 100.0%
28
 100.0%
22
 100.0%
9
 100.0%
38
 100.0%
23
 100.0%
56
 100.0%
70
 100.0%
H1N1 Month 6
6
 100.0%
28
 100.0%
22
 100.0%
9
 100.0%
38
 100.0%
23
 100.0%
56
 100.0%
70
 100.0%
Victoria Day 0
3
  50.0%
21
  75.0%
19
  86.4%
NA [1]  NA [1]  NA [1] 
43
  76.8%
NA [1] 
Victoria Month 6
6
 100.0%
28
 100.0%
22
 100.0%
NA [1]  NA [1]  NA [1] 
56
 100.0%
NA [1] 
H3N2 Day 0
0
   0.0%
17
  60.7%
18
  81.8%
NA [1]  NA [1]  NA [1] 
35
  62.5%
NA [1] 
H3N2 Month 6
6
 100.0%
28
 100.0%
22
 100.0%
NA [1]  NA [1]  NA [1] 
56
 100.0%
NA [1] 
[1]
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
10.Secondary Outcome
Title Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
Hide Description

A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.

Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 35 23 0 0 0 65 0
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1
5
  71.4%
31
  88.6%
19
  82.6%
55
  84.6%
Victoria
7
 100.0%
30
  85.7%
18
  78.3%
55
  84.6%
H3N2
7
 100.0%
35
 100.0%
22
  95.7%
64
  98.5%
11.Secondary Outcome
Title Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description

A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.

Time Frame Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1
5
  83.3%
18
  64.3%
12
  54.5%
0
   0.0%
1
   2.6%
0
   0.0%
35
  62.5%
1
   1.4%
Victoria
5
  83.3%
22
  78.6%
15
  68.2%
NA [1]  NA [1]  NA [1] 
42
  75.0%
NA [1] 
H3N2
6
 100.0%
22
  78.6%
18
  81.8%
NA [1]  NA [1]  NA [1] 
46
  82.1%
NA [1] 
[1]
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
12.Secondary Outcome
Title Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
Hide Description A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Time Frame Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 35 23 10 43 24 65 77
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Day 0
7
 100.0%
33
  94.3%
23
 100.0%
10
 100.0%
43
 100.0%
24
 100.0%
63
  96.9%
77
 100.0%
H1N1 Day 28
7
 100.0%
35
 100.0%
23
 100.0%
NA [1]  NA [1]  NA [1] 
65
 100.0%
NA [1] 
Victoria Day 0
2
  28.6%
5
  14.3%
7
  30.4%
1
  10.0%
9
  20.9%
7
  29.2%
14
  21.5%
17
  22.1%
Victoria Day 28
7
 100.0%
35
 100.0%
21
  91.3%
NA [1]  NA [1]  NA [1] 
63
  96.9%
NA [1] 
H3N2 Day 0
0
   0.0%
17
  48.6%
13
  56.5%
0
   0.0%
6
  14.0%
12
  50.0%
30
  46.2%
18
  23.4%
H3N2 Day 28
7
 100.0%
35
 100.0%
23
 100.0%
NA [1]  NA [1]  NA [1] 
65
 100.0%
NA [1] 
[1]
Data not planned to be collected at Day 28, but rather at Month 6.
13.Secondary Outcome
Title Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Time Frame Day 0 and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Day 0
6
 100.0%
26
  92.9%
22
 100.0%
9
 100.0%
38
 100.0%
23
 100.0%
54
  96.4%
70
 100.0%
H1N1 Month 6
6
 100.0%
28
 100.0%
22
 100.0%
8
  88.9%
36
  94.7%
21
  91.3%
56
 100.0%
65
  92.9%
Victoria Day 0
2
  33.3%
5
  17.9%
7
  31.8%
NA [1]  NA [1]  NA [1] 
14
  25.0%
NA [1] 
Victoria Month 6
6
 100.0%
26
  92.9%
20
  90.9%
NA [1]  NA [1]  NA [1] 
52
  92.9%
NA [1] 
H3N2 Day 0
0
   0.0%
13
  46.4%
12
  54.5%
NA [1]  NA [1]  NA [1] 
25
  44.6%
NA [1] 
H3N2 Month 6
6
 100.0%
28
 100.0%
22
 100.0%
NA [1]  NA [1]  NA [1] 
56
 100.0%
NA [1] 
[1]
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
14.Secondary Outcome
Title Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
Hide Description MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 35 23 0 0 0 65 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
H1N1
10.2
(3.0 to 34.8)
10.8
(7.9 to 14.7)
6.5
(4.7 to 8.8)
8.9
(7.1 to 11.2)
Victoria
10.8
(5.9 to 19.6)
9.4
(6.8 to 12.9)
8.6
(5.5 to 13.6)
9.3
(7.3 to 11.7)
H3N2
17.7
(7.2 to 43.5)
21.1
(16.3 to 27.4)
16.7
(11.4 to 24.6)
19.1
(15.6 to 23.4)
15.Secondary Outcome
Title Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description

MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.

Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.

Time Frame Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
H1N1
7.1
(2.0 to 25.5)
4.5
(3.3 to 6.0)
3.5
(2.6 to 4.7)
0.5
(0.4 to 0.8)
0.9
(0.7 to 1.1)
0.7
(0.7 to 0.8)
4.3
(3.4 to 5.3)
0.8
(0.7 to 0.9)
Victoria
17.0
(3.1 to 93.9)
9.2
(5.9 to 14.2)
6.2
(3.8 to 10.2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
8.4
(6.1 to 11.6)
NA [1] 
(NA to NA)
H3N2
25.4
(14.0 to 46.0)
7.9
(5.5 to 11.4)
8.5
(5.9 to 12.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
9.2
(7.2 to 11.8)
NA [1] 
(NA to NA)
[1]
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
16.Secondary Outcome
Title Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Hide Description Antibody titers were expressed as Geometric Mean Titers (GMTs).
Time Frame Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 35 23 0 0 0 65 0
Geometric Mean (90% Confidence Interval)
Unit of Measure: titer
H1N1 Day 0 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
359.1
(159.7 to 807.4)
235.4
(180.5 to 307.0)
237.6
(154.7 to 364.8)
247.3
(199.6 to 306.5)
H1N1 Day 28 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
5706.2
(3382.6 to 9626.0)
5860.4
(5072.5 to 6770.7)
2052.3
(1395.1 to 3019.0)
4007.7
(3274.8 to 4904.6)
Victoria Day 0 Number Analyzed 7 participants 35 participants 23 participants 0 participants 0 participants 0 participants 65 participants 0 participants
20.2
(8.3 to 49.2)
19.1
(13.9 to 26.2)
25.4
(16.6 to 38.9)
21.3
(16.8 to 26.9)
Victoria Day 28 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
49.3
(6.9 to 349.5)
42.3
(20.9 to 85.5)
80.8
(34.8 to 187.9)
54.3
(33.0 to 89.3)
H3N2 Day 0 Number Analyzed 7 participants 35 participants 23 participants 0 participants 0 participants 0 participants 65 participants 0 participants
30.0
(13.5 to 66.9)
84.9
(53.7 to 134.5)
139.5
(100.8 to 193.0)
90.5
(67.4 to 121.6)
H3N2 Day 28 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
90.1
(50.1 to 162.0)
1011.6
(509.5 to 2008.6)
1229.9
(586.5 to 2579.3)
832.9
(514.7 to 1347.8)
17.Secondary Outcome
Title Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Time Frame Day 0 and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
H1N1 Day 0 Number Analyzed 6 participants 27 participants 22 participants 9 participants 38 participants 23 participants 55 participants 70 participants
419.1
(172.0 to 1021.2)
254.8
(184.0 to 352.8)
221.2
(145.0 to 337.6)
292.0
(170.8 to 499.1)
441.3
(317.5 to 613.5)
212.8
(142.3 to 318.1)
254.2
(200.2 to 322.9)
329.3
(260.0 to 417.2)
H1N1 Month 6 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
5080.1
(2169.7 to 11894.4)
2359.7
(1852.0 to 3006.4)
892.2
(585.7 to 1359.0)
292.6
(173.6 to 493.0)
528.9
(377.5 to 741.0)
221.6
(155.0 to 316.8)
1748.2
(1347.3 to 2268.4)
368.3
(290.1 to 467.5)
Victoria Day 0 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
21.4
(7.2 to 64.0)
20.7
(13.9 to 30.7)
26.1
(16.8 to 40.6)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
22.7
(17.4 to 29.7)
NA [1] 
(NA to NA)
Victoria Month 6 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
284.5
(89.4 to 905.6)
140.0
(81.7 to 240.0)
113.1
(58.2 to 219.7)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
138.9
(95.2 to 202.6)
NA [1] 
(NA to NA)
H3N2 Day 0 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
34.1
(13.6 to 85.3)
78.4
(47.0 to 131.1)
136.5
(97.4 to 191.3)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
89.2
(65.5 to 121.5)
NA [1] 
(NA to NA)
H3N2 Month 6 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
264.1
(136.0 to 512.9)
618.2
(435.1 to 878.5)
638.2
(381.1 to 1068.8)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
571.5
(435.5 to 749.8)
NA [1] 
(NA to NA)
[1]
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
18.Secondary Outcome
Title Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
Hide Description Seropositivity was defined as antibody titers greater than or equal to 1:28.
Time Frame Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 35 23 0 0 0 65 0
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Day 0 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
7
 100.0%
34
 100.0%
23
 100.0%
64
 100.0%
H1N1 Day 28 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
7
 100.0%
34
 100.0%
23
 100.0%
64
 100.0%
Victoria Day 0 Number Analyzed 7 participants 35 participants 23 participants 0 participants 0 participants 0 participants 65 participants 0 participants
1
  14.3%
5
  14.3%
7
  30.4%
13
  20.0%
Victoria Day 28 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
3
  42.9%
15
  44.1%
12
  52.2%
30
  46.9%
H3N2 Day 0 Number Analyzed 7 participants 35 participants 23 participants 0 participants 0 participants 0 participants 65 participants 0 participants
4
  57.1%
26
  74.3%
22
  95.7%
52
  80.0%
H3N2 Day28 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
7
 100.0%
34
 100.0%
23
 100.0%
64
 100.0%
19.Secondary Outcome
Title Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Time Frame Day 0 and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Day 0 Number Analyzed 6 participants 27 participants 22 participants 9 participants 38 participants 23 participants 55 participants 70 participants
6
 100.0%
27
 100.0%
22
 100.0%
9
 100.0%
38
 100.0%
23
 100.0%
55
 100.0%
70
 100.0%
H1N1 Month 6 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
6
 100.0%
28
 100.0%
22
 100.0%
9
 100.0%
38
 100.0%
23
 100.0%
56
 100.0%
70
 100.0%
Victoria Day 0 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
1
  16.7%
5
  17.9%
7
  31.8%
NA [1]  NA [1]  NA [1] 
13
  23.2%
NA [1] 
Victoria Month 6 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
6
 100.0%
28
 100.0%
18
  81.8%
NA [1]  NA [1]  NA [1] 
52
  92.9%
NA [1] 
H3N2 Day 0 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
4
  66.7%
20
  71.4%
21
  95.5%
NA [1]  NA [1]  NA [1] 
45
  80.4%
NA [1] 
H3N2 Month 6 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
6
 100.0%
28
 100.0%
22
 100.0%
NA [1]  NA [1]  NA [1] 
56
 100.0%
NA [1] 
[1]
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
20.Secondary Outcome
Title Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
Hide Description Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 7 34 23 0 0 0 64 0
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Number Analyzed 7 participants 33 participants 23 participants 0 participants 0 participants 0 participants 63 participants 0 participants
6
  85.7%
33
 100.0%
17
  73.9%
56
  88.9%
Victoria Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
3
  42.9%
11
  32.4%
11
  47.8%
25
  39.1%
H3N2 Number Analyzed 7 participants 34 participants 23 participants 0 participants 0 participants 0 participants 64 participants 0 participants
4
  57.1%
32
  94.1%
16
  69.6%
52
  81.3%
21.Secondary Outcome
Title Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Hide Description

Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.

Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.

Time Frame Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
Overall Number of Participants Analyzed 6 28 22 9 38 23 56 70
Measure Type: Count of Participants
Unit of Measure: Participants
H1N1 Number Analyzed 6 participants 27 participants 22 participants 9 participants 38 participants 23 participants 55 participants 70 participants
5
  83.3%
22
  81.5%
10
  45.5%
0
   0.0%
2
   5.3%
0
   0.0%
37
  67.3%
2
   2.9%
Victoria Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
6
 100.0%
23
  82.1%
13
  59.1%
NA [1]  NA [1]  NA [1] 
42
  75.0%
NA [1] 
H3N2 Number Analyzed 6 participants 28 participants 22 participants 9 participants 38 participants 23 participants 56 participants 70 participants
5
  83.3%
21
  75.0%
13
  59.1%
NA [1]  NA [1]  NA [1] 
39
  69.6%
NA [1] 
[1]
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
22.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.
Time Frame During the 7 days (Day 0 – 6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 10 43 23 10 43 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
3
  30.0%
28
  65.1%
21
  91.3%
5
  50.0%
19
  44.2%
14
  58.3%
Grade 3 Pain
0
   0.0%
1
   2.3%
1
   4.3%
0
   0.0%
1
   2.3%
0
   0.0%
Any Redness
7
  70.0%
33
  76.7%
19
  82.6%
2
  20.0%
15
  34.9%
9
  37.5%
Grade 3 Redness
2
  20.0%
8
  18.6%
6
  26.1%
0
   0.0%
0
   0.0%
0
   0.0%
Any Swelling
5
  50.0%
23
  53.5%
11
  47.8%
1
  10.0%
10
  23.3%
5
  20.8%
Grade 3 Swelling
1
  10.0%
3
   7.0%
2
   8.7%
0
   0.0%
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Duration of Any Solicited Local Symptom
Hide Description Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.
Time Frame During the 7 days (Days 0 – 6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 6 30 20 5 19 14
Median (Inter-Quartile Range)
Unit of Measure: days
Pain [Dose 1] Number Analyzed 3 participants 23 participants 20 participants 5 participants 19 participants 14 participants
1.0
(1.0 to 2.0)
2.0
(1.0 to 5.0)
2.0
(1.0 to 5.0)
1.0
(1.0 to 5.0)
1.0
(1.0 to 7.0)
2.0
(1.0 to 4.0)
Redness [Dose 1] Number Analyzed 6 participants 30 participants 16 participants 2 participants 15 participants 9 participants
4.0
(1.0 to 6.0)
3.0
(1.0 to 7.0)
3.0
(1.0 to 6.0)
1.5
(1.0 to 2.0)
3.0
(1.0 to 7.0)
2.0
(1.0 to 5.0)
Swelling [Dose 1] Number Analyzed 5 participants 18 participants 9 participants 1 participants 10 participants 5 participants
2.0
(1.0 to 5.0)
3.0
(1.0 to 6.0)
2.0
(1.0 to 6.0)
1.0
(1.0 to 1.0)
2.0
(1.0 to 7.0)
2.0
(1.0 to 3.0)
Pain [Dose 2] Number Analyzed 2 participants 21 participants 14 participants 5 participants 19 participants 14 participants
1.5
(1.0 to 2.0)
1.0
(1.0 to 3.0)
2.0
(1.0 to 3.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Redness [Dose 2] Number Analyzed 4 participants 23 participants 13 participants 5 participants 19 participants 14 participants
3.0
(3.0 to 7.0)
3.0
(1.0 to 6.0)
2.0
(1.0 to 5.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Swelling [Dose 2] Number Analyzed 2 participants 16 participants 8 participants 5 participants 19 participants 14 participants
3.0
(2.0 to 4.0)
2.0
(1.0 to 6.0)
2.0
(1.0 to 4.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
24.Secondary Outcome
Title Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Time Frame During the 7 days (Days 0–6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 10 43 11 10 43 2
Measure Type: Count of Participants
Unit of Measure: Participants
Any Diarrhoea
5
  50.0%
8
  18.6%
2
  18.2%
2
  20.0%
7
  16.3%
0
   0.0%
Grade 3 Diarrhoea
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
Related Diarrhoea
5
  50.0%
3
   7.0%
1
   9.1%
2
  20.0%
3
   7.0%
0
   0.0%
Any Drowsiness
6
  60.0%
16
  37.2%
2
  18.2%
2
  20.0%
15
  34.9%
0
   0.0%
Grade 3 Drowsiness
0
   0.0%
3
   7.0%
1
   9.1%
0
   0.0%
2
   4.7%
0
   0.0%
Related Drowsiness
5
  50.0%
10
  23.3%
2
  18.2%
2
  20.0%
9
  20.9%
0
   0.0%
Any Irritability
6
  60.0%
20
  46.5%
4
  36.4%
5
  50.0%
14
  32.6%
0
   0.0%
Grade 3 Irritability
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
2
   4.7%
0
   0.0%
Related Irritability
5
  50.0%
14
  32.6%
3
  27.3%
4
  40.0%
10
  23.3%
0
   0.0%
Any Loss of Appetite
6
  60.0%
14
  32.6%
4
  36.4%
3
  30.0%
6
  14.0%
0
   0.0%
Grade 3 Loss of Appetite
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Loss of Appetite
4
  40.0%
8
  18.6%
4
  36.4%
2
  20.0%
3
   7.0%
0
   0.0%
Any Fever
5
  50.0%
14
  32.6%
4
  36.4%
3
  30.0%
11
  25.6%
0
   0.0%
Grade 3 Fever
1
  10.0%
1
   2.3%
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever
4
  40.0%
11
  25.6%
3
  27.3%
0
   0.0%
4
   9.3%
0
   0.0%
25.Secondary Outcome
Title Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Hide Description Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.
Time Frame During a 7-day follow-up period (Day 0-6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 5 14 3 5 15 0
Median (Inter-Quartile Range)
Unit of Measure: days
Diarrhoea [Dose 1] Number Analyzed 3 participants 6 participants 1 participants 2 participants 7 participants 0 participants
2.0
(2.0 to 3.0)
2.0
(1.0 to 4.0)
1.0
(1.0 to 1.0)
3.5
(1.0 to 6.0)
1.0
(1.0 to 3.0)
Drowsiness [Dose 1] Number Analyzed 4 participants 11 participants 1 participants 2 participants 15 participants 0 participants
1.5
(1.0 to 6.0)
1.0
(1.0 to 4.0)
3.0
(3.0 to 3.0)
2.0
(2.0 to 2.0)
2.0
(1.0 to 6.0)
Irritability [Dose 1] Number Analyzed 4 participants 14 participants 3 participants 5 participants 14 participants 0 participants
2.5
(1.0 to 4.0)
2.0
(1.0 to 5.0)
1.0
(1.0 to 2.0)
2.0
(1.0 to 6.0)
1.0
(1.0 to 5.0)
Loss of Appetite [Dose 1] Number Analyzed 5 participants 11 participants 3 participants 3 participants 6 participants 0 participants
2.0
(1.0 to 6.0)
3.0
(1.0 to 5.0)
1.0
(1.0 to 3.0)
2.0
(1.0 to 7.0)
1.5
(1.0 to 3.0)
Fever [Dose 1] Number Analyzed 3 participants 10 participants 2 participants 3 participants 11 participants 0 participants
4.0
(1.0 to 6.0)
1.5
(1.0 to 3.0)
1.5
(1.0 to 2.0)
2.0
(2.0 to 2.0)
2.0
(1.0 to 6.0)
Diarrhoea [Dose 2] Number Analyzed 4 participants 4 participants 1 participants 5 participants 15 participants 0 participants
1.0
(1.0 to 3.0)
1.0
(1.0 to 4.0)
1.0
(1.0 to 1.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Drowsiness [Dose 2] Number Analyzed 4 participants 9 participants 2 participants 5 participants 15 participants 0 participants
1.5
(1.0 to 3.0)
1.0
(1.0 to 2.0)
1.0
(1.0 to 1.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Irritability [Dose 2] Number Analyzed 5 participants 12 participants 2 participants 5 participants 15 participants 0 participants
2.0
(2.0 to 7.0)
2.0
(1.0 to 4.0)
2.0
(1.0 to 3.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Loss of Appetite [Dose 2] Number Analyzed 4 participants 9 participants 2 participants 5 participants 15 participants 0 participants
2.0
(1.0 to 5.0)
2.0
(1.0 to 4.0)
1.0
(1.0 to 1.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Fever [Dose 2] Number Analyzed 3 participants 9 participants 2 participants 5 participants 15 participants 0 participants
2.0
(1.0 to 2.0)
1.0
(1.0 to 7.0)
1.0
(1.0 to 1.0)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
None of the subjects in any of the Havrix Groups received a second vaccine dose.
26.Secondary Outcome
Title Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Time Frame During a 7-day follow-up period (Day 0-6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 0 0 12 0 0 22
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia
0
   0.0%
0
   0.0%
Grade 3 Arthralgia
0
   0.0%
0
   0.0%
Related Arthralgia
0
   0.0%
0
   0.0%
Any Fatigue
5
  41.7%
8
  36.4%
Grade 3 Fatigue
0
   0.0%
0
   0.0%
Related Fatigue
4
  33.3%
6
  27.3%
Any Gatrointestinal Symptoms
1
   8.3%
1
   4.5%
Grade 3 Gatrointestinal Symptoms
0
   0.0%
0
   0.0%
Related Gatrointestinal Symptoms
1
   8.3%
1
   4.5%
Any Headache
4
  33.3%
4
  18.2%
Grade 3 Headache
0
   0.0%
0
   0.0%
Related Headache
3
  25.0%
3
  13.6%
Any Myalgia
1
   8.3%
2
   9.1%
Grade 3 Myalgia
0
   0.0%
0
   0.0%
Related Myalgia
1
   8.3%
2
   9.1%
Any Shivering
2
  16.7%
0
   0.0%
Grade 3 Shivering
0
   0.0%
0
   0.0%
Related Shivering
2
  16.7%
0
   0.0%
Any Sweating
0
   0.0%
0
   0.0%
Grade 3 Sweating
0
   0.0%
0
   0.0%
Related Sweating
0
   0.0%
0
   0.0%
Any Fever
3
  25.0%
0
   0.0%
Grade 3 Fever
0
   0.0%
0
   0.0%
Related Fever
2
  16.7%
0
   0.0%
27.Secondary Outcome
Title Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Hide Description Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.
Time Frame During a 7-day follow-up period (Day 0-6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 0 0 4 0 0 8
Median (Inter-Quartile Range)
Unit of Measure: days
Fatigue [Dose 1] Number Analyzed 0 participants 0 participants 4 participants 0 participants 0 participants 8 participants
1.5
(1.0 to 5.0)
1.0
(1.0 to 2.0)
Fatigue [Dose 2] Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants 8 participants
4.0
(1.0 to 7.0)
NA [1] 
(NA to NA)
Gastrointestinal Symptoms [Dose 1] Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 1 participants
2.0
(2.0 to 2.0)
1.0
(1.0 to 1.0)
Gastrointestinal symptoms [Dose 2] Number Analyzed 0 participants 0 participants 4 participants 0 participants 0 participants 8 participants
NA [2] 
(NA to NA)
NA [1] 
(NA to NA)
Headache [Dose 1] Number Analyzed 0 participants 0 participants 4 participants 0 participants 0 participants 4 participants
3.0
(2.0 to 4.0)
3.0
(1.0 to 7.0)
Headache [Dose 2] Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants 8 participants
3.5
(3.0 to 4.0)
NA [1] 
(NA to NA)
Myalgia [Dose 1] Number Analyzed 0 participants 0 participants 4 participants 0 participants 0 participants 2 participants
NA [3] 
(NA to NA)
1.0
(1.0 to 1.0)
Myalgia [Dose 2] Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 8 participants
1.0
(1.0 to 1.0)
NA [1] 
(NA to NA)
Shivering [Dose 1] Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants 8 participants
1.0
(1.0 to 1.0)
NA [3] 
(NA to NA)
Shivering [Dose 2] Number Analyzed 0 participants 0 participants 4 participants 0 participants 0 participants 8 participants
NA [2] 
(NA to NA)
NA [1] 
(NA to NA)
Fever [Dose 1] Number Analyzed 0 participants 0 participants 4 participants 0 participants 0 participants 8 participants
1.0
(1.0 to 1.0)
NA [3] 
(NA to NA)
Fever [Dose2] Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 8 participants
1.0
(1.0 to 1.0)
NA [1] 
(NA to NA)
[1]
Dose 2 involved subjects in Group receiving Fluarix vaccine.
[2]
None of the subjects aged above 6 years in this group experienced this symptom
[3]
None of the subjects aged above 6 years in this group experienced this symptom.
28.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Any was defined as any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination.

Time Frame During a 28 day follow-up period (Day 0-27) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 10 44 23 10 43 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
6
  60.0%
20
  45.5%
7
  30.4%
3
  30.0%
15
  34.9%
7
  29.2%
Grade 3 AEs
3
  30.0%
4
   9.1%
1
   4.3%
0
   0.0%
1
   2.3%
1
   4.2%
Related AEs
2
  20.0%
1
   2.3%
2
   8.7%
0
   0.0%
1
   2.3%
0
   0.0%
29.Secondary Outcome
Title Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
Hide Description

MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.

AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis.

Time Frame During the entire study period (up to Month 6)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 10 44 23 10 43 24
Measure Type: Count of Participants
Unit of Measure: Participants
MAEs
4
  40.0%
11
  25.0%
2
   8.7%
3
  30.0%
7
  16.3%
1
   4.2%
AESIs / pIMDs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AEs of special interest
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
30.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Up to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 10 44 23 10 43 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
31.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Up to Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description:
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
Overall Number of Participants Analyzed 10 44 23 10 43 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
  10.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
Adverse Event Reporting Description The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
 
Arm/Group Title Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Hide Arm/Group Description Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status. Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine. Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
All-Cause Mortality
Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   1/44 (2.27%)   0/23 (0.00%)   0/10 (0.00%)   0/43 (0.00%)   0/24 (0.00%) 
Infections and infestations             
Upper respiratory tract infection *  0/10 (0.00%)  1/44 (2.27%)  0/23 (0.00%)  0/10 (0.00%)  0/43 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications             
Head injury *  1/10 (10.00%)  0/44 (0.00%)  0/23 (0.00%)  0/10 (0.00%)  0/43 (0.00%)  0/24 (0.00%) 
*
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 5%
Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   41/44 (93.18%)   23/23 (100.00%)   9/10 (90.00%)   34/43 (79.07%)   20/24 (83.33%) 
Gastrointestinal disorders             
Lip haemorrhage *  0/10 (0.00%)  0/44 (0.00%)  0/23 (0.00%)  1/10 (10.00%)  0/43 (0.00%)  0/24 (0.00%) 
Tooth discolouration *  1/10 (10.00%)  0/44 (0.00%)  0/23 (0.00%)  0/10 (0.00%)  0/43 (0.00%)  0/24 (0.00%) 
Vomiting *  1/10 (10.00%)  1/44 (2.27%)  0/23 (0.00%)  0/10 (0.00%)  0/43 (0.00%)  0/24 (0.00%) 
General disorders             
Pain   3/10 (30.00%)  28/43 (65.12%)  21/23 (91.30%)  5/10 (50.00%)  19/43 (44.19%)  14/24 (58.33%) 
Redness   7/10 (70.00%)  33/43 (76.74%)  19/23 (82.61%)  2/10 (20.00%)  15/43 (34.88%)  9/24 (37.50%) 
Swelling   5/10 (50.00%)  23/43 (53.49%)  11/23 (47.83%)  1/10 (10.00%)  10/43 (23.26%)  5/24 (20.83%) 
Diarrhoea   5/10 (50.00%)  8/43 (18.60%)  2/11 (18.18%)  2/10 (20.00%)  7/43 (16.28%)  0/2 (0.00%) 
Drowsiness   6/10 (60.00%)  16/43 (37.21%)  2/11 (18.18%)  2/10 (20.00%)  15/43 (34.88%)  0/2 (0.00%) 
Irritability   6/10 (60.00%)  20/43 (46.51%)  4/11 (36.36%)  5/10 (50.00%)  14/43 (32.56%)  0/2 (0.00%) 
Loss of Appetite   6/10 (60.00%)  14/43 (32.56%)  4/11 (36.36%)  3/10 (30.00%)  6/43 (13.95%)  0/2 (0.00%) 
Fever  [1]  5/10 (50.00%)  14/43 (32.56%)  4/11 (36.36%)  3/10 (30.00%)  11/43 (25.58%)  0/2 (0.00%) 
Pyrexia *  1/10 (10.00%)  1/44 (2.27%)  0/23 (0.00%)  0/10 (0.00%)  2/43 (4.65%)  0/24 (0.00%) 
Infections and infestations             
Upper respiratory tract infection *  2/10 (20.00%)  9/44 (20.45%)  0/23 (0.00%)  0/10 (0.00%)  6/43 (13.95%)  0/24 (0.00%) 
Gastroenteritis *  0/10 (0.00%)  4/44 (9.09%)  0/23 (0.00%)  0/10 (0.00%)  1/43 (2.33%)  0/24 (0.00%) 
Nasopharyngitis *  1/10 (10.00%)  0/44 (0.00%)  2/23 (8.70%)  0/10 (0.00%)  1/43 (2.33%)  2/24 (8.33%) 
Ear infection *  1/10 (10.00%)  0/44 (0.00%)  0/23 (0.00%)  0/10 (0.00%)  0/43 (0.00%)  0/24 (0.00%) 
Varicella *  1/10 (10.00%)  0/44 (0.00%)  0/23 (0.00%)  0/10 (0.00%)  0/43 (0.00%)  0/24 (0.00%) 
Nervous system disorders             
Loss of consciousness *  0/10 (0.00%)  0/44 (0.00%)  0/23 (0.00%)  1/10 (10.00%)  0/43 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough *  0/10 (0.00%)  0/44 (0.00%)  1/23 (4.35%)  1/10 (10.00%)  2/43 (4.65%)  1/24 (4.17%) 
Dysphonia *  0/10 (0.00%)  0/44 (0.00%)  0/23 (0.00%)  1/10 (10.00%)  0/43 (0.00%)  0/24 (0.00%) 
Oropharyngeal pain *  0/10 (0.00%)  0/44 (0.00%)  1/23 (4.35%)  1/10 (10.00%)  0/43 (0.00%)  1/24 (4.17%) 
Asthma *  1/10 (10.00%)  0/44 (0.00%)  0/23 (0.00%)  0/10 (0.00%)  0/43 (0.00%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders             
Erythema *  1/10 (10.00%)  0/44 (0.00%)  1/23 (4.35%)  0/10 (0.00%)  1/43 (2.33%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
For subjects less than 6 years old
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01196026     History of Changes
Other Study ID Numbers: 114451
First Submitted: September 3, 2010
First Posted: September 8, 2010
Results First Submitted: March 12, 2012
Results First Posted: June 28, 2012
Last Update Posted: September 24, 2018