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Trial record 22 of 28 for:    pandemrix AND influenza vaccine

Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM

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: NCT01190215
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : July 13, 2012
Last Update Posted : September 7, 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: FluarixTM
Biological: HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Period Title: Up to Day 28
Started 38 39
Completed 38 39
Not Completed 0 0
Period Title: Up to Month 6
Started 38 39
Completed 36 39
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
Arm/Group Title Fluarix Group Havrix Group Total
Hide Arm/Group Description Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 38 39 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 39 participants 77 participants
14.6  (2.22) 14.7  (2.28) 14.7  (2.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 39 participants 77 participants
Female
22
  57.9%
19
  48.7%
41
  53.2%
Male
16
  42.1%
20
  51.3%
36
  46.8%
1.Primary Outcome
Title Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Hide Description

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

Day 28 data were presented only for the Fluarix Group.

Titres were expressed as geometric mean antibody titre.

Time Frame At Day 0 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titres
Flu A/Cal/7/09 H1N1 [Day 0]
150.1
(105.8 to 213.0)
150.3
(106.0 to 213.3)
Flu A/Cal/7/09 H1N1 [Day 28]
646.8
(534.6 to 782.6)
NA [1] 
(NA to NA)
[1]
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
2.Primary Outcome
Title Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Hide Description

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.

Day 28 data was presented only for the Fluarix Group.

Time Frame At Day 0 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 39
Measure Type: Number
Unit of Measure: Subjects
Flu A/Cal/7/09 H1N1 [Day 0] 33 39
Flu A/Cal/7/09 H1N1 [Day 28] 33 NA [1] 
[1]
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
3.Primary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Hide Description

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 0
Measure Type: Number
Unit of Measure: Subjects
16
4.Primary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Hide Description

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 0 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 39
Measure Type: Number
Unit of Measure: Subjects
Flu A/Cal/7/09 H1N1 [Day 0] 31 36
Flu A/Cal/7/09 H1N1 [Day 28] 33 NA [1] 
[1]
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
5.Primary Outcome
Title Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Hide Description

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

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

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
4.3
(2.9 to 6.4)
6.Secondary Outcome
Title Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Day 28 data were presented for the Fluarix Group only.

Titres were expressed as geometric mean antibody titres (GMTs).

Time Frame At Day 0 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titres
Flu A/Cal/7/09 H1N1 [Day 0]
150.1
(105.8 to 213.0)
150.3
(106.0 to 213.3)
Flu A/Cal/7/09 H1N1 [Day 28]
646.8
(534.6 to 782.6)
NA [1] 
(NA to NA)
Flu B/Bri/60/08 Victoria [Day 0]
22.2
(14.7 to 33.5)
21.0
(14.8 to 30.0)
Flu B/Bri/60/08 Victoria [Day 28]
320.1
(216.8 to 472.6)
NA [1] 
(NA to NA)
Flu A/Vic/210/09 H3N2 [Day 0]
20.0
(13.0 to 30.8)
279.2
(202.1 to 385.8)
Flu A/Vic/210/09 H3N2 [Day 28]
20.3
(13.9 to 29.8)
NA [1] 
(NA to NA)
[1]
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
7.Secondary Outcome
Title Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.

Titres were expressed as geometric mean antibody titres (GMTs).

Time Frame At Day 0 and at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 35 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titres
Flu B/Bri/60/08 Victoria [Day 0]
22.9
(15.6 to 33.8)
NA [1] 
(NA to NA)
Flu B/Bri/60/08 Victoria [Month 6]
242.4
(173.9 to 337.8)
NA [1] 
(NA to NA)
Flu A/Cal/7/09 H1N1 [Day 0]
169.7
(116.2 to 247.8)
152.7
(105.6 to 220.8)
Flu A/Cal/7/09 H1N1 [Month 6]
346.4
(273.4 to 438.8)
131.4
(92.5 to 186.6)
Flu A/Vic/210/09 H3N2 [Day 0]
17.9
(12.7 to 25.3)
NA [1] 
(NA to NA)
Flu A/Vic/210/09 H3N2 [Month 6]
160.1
(118.1 to 217.0)
NA [1] 
(NA to NA)
[1]
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
8.Secondary Outcome
Title Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 0 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 39
Measure Type: Number
Unit of Measure: Subjects
Flu A/Cal/7/09 H1N1 [Day 0] 33 39
Flu A/Cal/7/09 H1N1 [Day 28] 33 NA [1] 
Flu B/Bri/60/08 Victoria [Day 0] 26 31
Flu B/Bri/60/08 Victoria [Day 28] 33 NA [1] 
Flu A/Vic/210/09 H3N2 [Day 0] 24 28
Flu A/Vic/210/09 H3N2 [Day 28] 33 NA [1] 
[1]
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
9.Secondary Outcome
Title Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.

Time Frame At Day 0 and at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 35 37
Measure Type: Number
Unit of Measure: Subjects
Flu B/Bri/60/08 Victoria [Day 0] 29 NA [1] 
Flu B/Bri/60/08 Victoria [Month 6] 35 NA [1] 
Flu A/Cal/7/09 H1N1 [Day 0] 35 37
Flu A/Cal/7/09 H1N1 [Month 6] 35 37
Flu A/Vic/210/09 H3N2 [Day 0] 25 NA [1] 
Flu A/Vic/210/09 H3N2 [Month 6] 35 NA [1] 
[1]
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
10.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 0
Measure Type: Number
Unit of Measure: Subjects
Flu A/Cal/7/09 H1N1 16
Flu B/Bri/60/08 Victoria 28
Flu A/Vic/210/09 H3N2 29
11.Secondary Outcome
Title Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.

Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 35 37
Measure Type: Number
Unit of Measure: Subjects
Flu B/Bri/60/08 Victoria 29 NA [1] 
Flu A/Cal/7/09 H1N1 8 2
Flu A/Vic/210/09 H3N2 30 NA [1] 
[1]
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
12.Secondary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 0 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 39
Measure Type: Number
Unit of Measure: Subjects
Flu A/Cal/7/09 H1N1 [Day 0] 31 36
Flu A/Cal/7/09 H1N1 [Day 28] 33 NA [1] 
Flu B/Bri/60/08 Victoria [Day 0] 13 11
Flu B/Bri/60/08 Victoria [Day 28] 33 NA [1] 
Flu A/Vic/210/09 H3N2 [Day 0] 12 16
Flu A/Vic/210/09 H3N2 [Day 28] 33 NA [1] 
[1]
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
13.Secondary Outcome
Title Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.

Time Frame At Day 0 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 35 37
Measure Type: Number
Unit of Measure: Subjects
Flu B/Bri/60/08 Victoria [Day 0] 13 NA [1] 
Flu B/Bri/60/08 Victoria [Month 6] 33 NA [1] 
Flu A/Cal/7/09 H1N1 [Day 0] 33 34
Flu A/Cal/7/09 H1N1 [Month 6] 35 34
Flu A/Vic/210/09 H3N2 [Day 0] 13 NA [1] 
Flu A/Vic/210/09 H3N2 [Month 6] 34 NA [1] 
[1]
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
14.Secondary Outcome
Title Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

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

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Flu A/Cal/7/09 H1N1
4.3
(2.9 to 6.4)
Flu B/Bri/60/08 Victoria
14.4
(9.4 to 22.0)
Flu A/Vic/210/09 H3N2
14.0
(9.3 to 21.1)
15.Secondary Outcome
Title Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

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

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.

Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 35 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Flu B/Bri/60/08 Victoria
10.6
(7.5 to 14.9)
NA [1] 
(NA to NA)
Flu A/Cal/7/09 H1N1
2.0
(1.6 to 2.7)
0.9
(0.7 to 1.1)
Flu A/Vic/210/09 H3N2
8.9
(6.6 to 12.0)
NA [1] 
(NA to NA)
[1]
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
16.Secondary Outcome
Title Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.

Day 28 data were presented for the Fluarix Group only.

Titres were expressed as geometric mean antibody titres (GMTs).

Time Frame At Day 0 and at Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: titre
Flu B/Bri/60/08 Victoria [Day 0]
26.0
(20.2 to 33.6)
24.5
(18.9 to 31.9)
Flu B/Bri/60/08 Victoria [Day 28]
257.9
(158.5 to 419.5)
NA [1] 
(NA to NA)
Flu A/Cal/7/09 H1N1 [Day 0]
119.7
(95.2 to 150.5)
137.7
(108.0 to 175.5)
Flu A/Cal/7/09 H1N1 [Day 28]
1512.4
(1077.9 to 2122.1)
NA [1] 
(NA to NA)
Flu A/Per/16/09 H3N2 [Day 0]
69.8
(50.5 to 96.5)
72.6
(55.2 to 95.5)
Flu A/Per/16/09 H3N2 [Day 28]
614.5
(371.4 to 1016.7)
NA [1] 
(NA to NA)
[1]
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
17.Secondary Outcome
Title Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Hide Description

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.

Titres were expressed as geometric mean antibody titres (GMTs).

Time Frame At Day 0 and at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 35 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: titre
Flu B/Bri/60/08 Victoria [Day 0]
25.1
(19.7 to 32.1)
NA [1] 
(NA to NA)
Flu B/Bri/60/08 Victoria [Month 6]
199.5
(145.8 to 273.0)
NA [1] 
(NA to NA)
Flu A/Cal/7/09 H1N1 [Day 0]
119.4
(94.5 to 150.8)
138.3
(107.5 to 178.0)
Flu A/Cal/7/09 H1N1 [Month 6]
390.6
(291.4 to 523.8)
115.3
(82.4 to 161.4)
Flu A/Per/16/09 H3N2 [Day 0]
62.5
(49.5 to 78.8)
NA [1] 
(NA to NA)
Flu A/Per/16/09 H3N2 [Month 6]
266.8
(173.6 to 410.1)
NA [1] 
(NA to NA)
[1]
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
18.Secondary Outcome
Title Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Hide Description

A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.

Day 28 data were presented for the Fluarix Group only.

Time Frame At Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 33 0
Measure Type: Number
Unit of Measure: Subjects
Flu B/Bri/60/08 Victoria 25
Flu A/Cal/7/09 H1N1 29
Flu A/Per/16/09 H3N2 22
19.Secondary Outcome
Title Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Hide Description

A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.

At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.

Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 35 37
Measure Type: Number
Unit of Measure: Subjects
Flu B/Bri/60/08 Victoria 28 NA [1] 
Flu A/Cal/7/09 H1N1 13 2
Flu A/Per/16/09 H3N2 17 NA [1] 
[1]
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
20.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Time Frame Within 7 days (Day 0 – Day 6) after vaccination
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Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
Any pain 35 24
Grade 3 pain 2 0
Any redness 6 5
Grade 3 redness 0 0
Any swelling 5 0
Grade 3 swelling 1 0
21.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Hide Description

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).

Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius.

Time Frame Within 7 days (Day 0 – Day 6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
Any arthralgia 4 5
Grade 3 arthralgia 0 0
Any fatigue 25 24
Grade 3 fatigue 1 1
Any gastrointestinal symptoms 8 3
Grade 3 gastrointestinal symptoms 2 0
Any headache 24 16
Grade 3 headache 1 0
Any myalgia 16 16
Grade 3 myalgia 0 1
Any shivering 18 9
Grade 3 shivering 0 0
Any sweating 9 4
Grade 3 sweating 0 0
Any temperature >= 37.5°C 4 1
Grade 3 temperature > 39.0°C 0 0
22.Secondary Outcome
Title Number of Days With Any Solicited Local Symptoms.
Hide Description

Solicited local symptoms assessed were pain, redness and swelling.

Inter-quartile range assessed was the 25th percentile and the 75th percentile.

Time Frame Within 7 days (Day 0 – Day 6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Median (Inter-Quartile Range)
Unit of Measure: Days
Pain
2.0
(1.0 to 3.0)
2.0
(1.0 to 2.5)
Redness
2.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
Swelling
2.0
(2.0 to 3.0)
0
(0 to 0)
23.Secondary Outcome
Title Number of Days With Grade 3 Solicited Local Symptoms.
Hide Description

Solicited local symptoms assessed were pain and swelling.

Grade 3 redness/swelling = redness/swelling above 50 millimetres.

Inter-quartile range assessed was the 25th percentile and the 75th percentile.

Time Frame Within 7 days (Day 0 – Day 6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Median (Inter-Quartile Range)
Unit of Measure: Days
Pain
1.0
(1.0 to 1.0)
0
(0 to 0)
Swelling
1.0
(1.0 to 1.0)
0
(0 to 0)
24.Secondary Outcome
Title Number of Days With Any Solicited General Symptoms.
Hide Description

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).

Inter-quartile range assessed was the 25th percentile and the 75th percentile.

Time Frame Within 7 days (Day 0 – Day 6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Median (Inter-Quartile Range)
Unit of Measure: Days
Arthralgia
2.0
(1.5 to 4.0)
1.0
(1.0 to 2.0)
Fatigue
2.0
(1.0 to 4.0)
2.0
(1.0 to 3.0)
Gastrointestinal
1.0
(1.0 to 2.0)
1.0
(1.0 to 3.0)
Headache
2.0
(1. to 3.0)
1.0
(1.0 to 2.0)
Myalgia
2.0
(1.5 to 3.5)
2.0
(1.0 to 3.0)
Sweating
1.0
(1.0 to 1.0)
2.0
(2.0 to 2.5)
Shivering
2.0
(1.0 to 4.0)
1.0
(1.0 to 1.0)
Temperature
1.0
(1.0 to 1.5)
1.0
(1.0 to 1.0)
25.Secondary Outcome
Title Number of Days With Grade 3 Solicited General Symptoms.
Hide Description

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.

Grade 3 symptom = general symptom that prevented normal activity.

Inter-quartile range assessed was the 25th percentile and the 75th percentile.

Time Frame Within 7 days (Day 0 – Day 6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Median (Inter-Quartile Range)
Unit of Measure: Days
Fatigue
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
Gastrointestinal
1.0
(1.0 to 1.0)
0
(0 to 0)
Headache
1.0
(1.0 to 1.0)
0
(0 to 0)
Myalgia
0
(0 to 0)
1.0
(1.0 to 1.0)
26.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Hide Description

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.

Time Frame Within 28 days (Day 0 – Day 27) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
Any 12 11
Grade 3 1 2
Related to vaccination 4 1
27.Secondary Outcome
Title Number of Subjects Reporting Medically-attended Events (MAEs).
Hide Description For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time Frame Within the 28-day (Days 0-27) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
1 3
28.Secondary Outcome
Title Number of Subjects Reporting Medically-attended Events (MAEs).
Hide Description For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time Frame During the entire study period (Up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
2 4
29.Secondary Outcome
Title Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
Hide Description Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time Frame During the entire study period (Up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
0 0
30.Secondary Outcome
Title Number of Subjects Reporting Adverse Events of Special Interest.
Hide Description Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
Time Frame During the entire study period (Up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
0 0
31.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame Within the 28-day (Days 0-27) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
0 0
32.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame During the entire study period (Up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: Subjects
1 0
Time Frame Serious adverse events were assessed up to Day 28 and during the entire study period, up to Month 6. Systematically and non-systematically assessed frequent adverse events were assessed during the 7 day and 28 day post-vaccination period respectively.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluarix Group Havrix Group
Hide Arm/Group Description Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
All-Cause Mortality
Fluarix Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluarix Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/38 (2.63%)   0/39 (0.00%) 
Infections and infestations     
Acute tonsillitis *  1/38 (2.63%)  0/39 (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 Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   37/38 (97.37%)   34/39 (87.18%) 
General disorders     
Pain   35/38 (92.11%)  24/39 (61.54%) 
Redness   6/38 (15.79%)  5/39 (12.82%) 
Swelling   5/38 (13.16%)  0/39 (0.00%) 
Arthralgia   4/38 (10.53%)  5/39 (12.82%) 
Fatigue   25/38 (65.79%)  24/39 (61.54%) 
Gastrointestinal symptoms   8/38 (21.05%)  3/39 (7.69%) 
Headache   24/38 (63.16%)  16/39 (41.03%) 
Myalgia   16/38 (42.11%)  16/39 (41.03%) 
Shivering   18/38 (47.37%)  9/39 (23.08%) 
Sweating   9/38 (23.68%)  4/39 (10.26%) 
Temperature   4/38 (10.53%)  1/39 (2.56%) 
Infections and infestations     
Upper respiratory tract infection *  3/38 (7.89%)  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders     
Neck pain *  2/38 (5.26%)  0/39 (0.00%) 
Nervous system disorders     
Headache *  1/38 (2.63%)  2/39 (5.13%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain *  1/38 (2.63%)  2/39 (5.13%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01190215     History of Changes
Other Study ID Numbers: 114452
First Submitted: August 26, 2010
First Posted: August 27, 2010
Results First Submitted: January 12, 2012
Results First Posted: July 13, 2012
Last Update Posted: September 7, 2018