Trial Outcomes & Findings for Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM (NCT NCT01190215)
NCT ID: NCT01190215
Last Updated: 2018-09-07
Results Overview
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.
COMPLETED
PHASE4
77 participants
At Day 0 and Day 28
2018-09-07
Participant Flow
Participant milestones
| Measure |
Fluarix Group
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.
|
Havrix Group
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.
|
|---|---|---|
|
Up to Day 28
STARTED
|
38
|
39
|
|
Up to Day 28
COMPLETED
|
38
|
39
|
|
Up to Day 28
NOT COMPLETED
|
0
|
0
|
|
Up to Month 6
STARTED
|
38
|
39
|
|
Up to Month 6
COMPLETED
|
36
|
39
|
|
Up to Month 6
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Fluarix Group
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.
|
Havrix Group
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.
|
|---|---|---|
|
Up to Month 6
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
Baseline characteristics by cohort
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.6 Years
STANDARD_DEVIATION 2.22 • n=5 Participants
|
14.7 Years
STANDARD_DEVIATION 2.28 • n=7 Participants
|
14.7 Years
STANDARD_DEVIATION 2.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0 and Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Flu A/Cal/7/09 H1N1 [Day 0]
|
150.1 Titres
Interval 105.8 to 213.0
|
150.3 Titres
Interval 106.0 to 213.3
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Flu A/Cal/7/09 H1N1 [Day 28]
|
646.8 Titres
Interval 534.6 to 782.6
|
NA Titres
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
PRIMARY outcome
Timeframe: At Day 0 and Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Flu A/Cal/7/09 H1N1 [Day 0]
|
33 Subjects
|
39 Subjects
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Flu A/Cal/7/09 H1N1 [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
PRIMARY outcome
Timeframe: At Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
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.
|
|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
|
16 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Day 0 and Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Flu A/Cal/7/09 H1N1 [Day 0]
|
31 Subjects
|
36 Subjects
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Flu A/Cal/7/09 H1N1 [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
PRIMARY outcome
Timeframe: At Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
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.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
|
4.3 Ratio
Interval 2.9 to 6.4
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and Day 28Population: 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.
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).
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
150.1 Titres
Interval 105.8 to 213.0
|
150.3 Titres
Interval 106.0 to 213.3
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 28]
|
646.8 Titres
Interval 534.6 to 782.6
|
NA Titres
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
22.2 Titres
Interval 14.7 to 33.5
|
21.0 Titres
Interval 14.8 to 30.0
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 28]
|
320.1 Titres
Interval 216.8 to 472.6
|
NA Titres
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 0]
|
20.0 Titres
Interval 13.0 to 30.8
|
279.2 Titres
Interval 202.1 to 385.8
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 28]
|
20.3 Titres
Interval 13.9 to 29.8
|
NA Titres
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
SECONDARY outcome
Timeframe: At Day 0 and at Month 6Population: 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.
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).
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
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.
|
Havrix Group
n=37 Participants
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.
|
|---|---|---|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Month 6]
|
346.4 Titres
Interval 273.4 to 438.8
|
131.4 Titres
Interval 92.5 to 186.6
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
22.9 Titres
Interval 15.6 to 33.8
|
NA Titres
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Month 6]
|
242.4 Titres
Interval 173.9 to 337.8
|
NA Titres
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
169.7 Titres
Interval 116.2 to 247.8
|
152.7 Titres
Interval 105.6 to 220.8
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 0]
|
17.9 Titres
Interval 12.7 to 25.3
|
NA Titres
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Month 6]
|
160.1 Titres
Interval 118.1 to 217.0
|
NA Titres
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
SECONDARY outcome
Timeframe: At Day 0 and Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
33 Subjects
|
39 Subjects
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
26 Subjects
|
31 Subjects
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 0]
|
24 Subjects
|
28 Subjects
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
SECONDARY outcome
Timeframe: At Day 0 and at Month 6Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
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.
|
Havrix Group
n=37 Participants
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.
|
|---|---|---|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
29 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Month 6]
|
35 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
35 Subjects
|
37 Subjects
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Month 6]
|
35 Subjects
|
37 Subjects
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 0]
|
25 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Month 6]
|
35 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
SECONDARY outcome
Timeframe: At Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
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.
|
|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1
|
16 Subjects
|
—
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
28 Subjects
|
—
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2
|
29 Subjects
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
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.
|
Havrix Group
n=37 Participants
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.
|
|---|---|---|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
29 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1
|
8 Subjects
|
2 Subjects
|
|
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2
|
30 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
SECONDARY outcome
Timeframe: At Day 0 and Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
31 Subjects
|
36 Subjects
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
13 Subjects
|
11 Subjects
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 0]
|
12 Subjects
|
16 Subjects
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 28]
|
33 Subjects
|
NA Subjects
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
SECONDARY outcome
Timeframe: At Day 0 and Month 6Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
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.
|
Havrix Group
n=37 Participants
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.
|
|---|---|---|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
13 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Month 6]
|
33 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
33 Subjects
|
34 Subjects
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Month 6]
|
35 Subjects
|
34 Subjects
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Day 0]
|
13 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2 [Month 6]
|
34 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
SECONDARY outcome
Timeframe: At Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
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.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1
|
4.3 Ratio
Interval 2.9 to 6.4
|
—
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
14.4 Ratio
Interval 9.4 to 22.0
|
—
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2
|
14.0 Ratio
Interval 9.3 to 21.1
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
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.
|
Havrix Group
n=37 Participants
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.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
10.6 Ratio
Interval 7.5 to 14.9
|
NA Ratio
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1
|
2.0 Ratio
Interval 1.6 to 2.7
|
0.9 Ratio
Interval 0.7 to 1.1
|
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Flu A/Vic/210/09 H3N2
|
8.9 Ratio
Interval 6.6 to 12.0
|
NA Ratio
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
SECONDARY outcome
Timeframe: At Day 0 and at Day 28Population: 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.
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).
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 28]
|
1512.4 titre
Interval 1077.9 to 2122.1
|
NA titre
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Per/16/09 H3N2 [Day 0]
|
69.8 titre
Interval 50.5 to 96.5
|
72.6 titre
Interval 55.2 to 95.5
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
26.0 titre
Interval 20.2 to 33.6
|
24.5 titre
Interval 18.9 to 31.9
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 28]
|
257.9 titre
Interval 158.5 to 419.5
|
NA titre
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
119.7 titre
Interval 95.2 to 150.5
|
137.7 titre
Interval 108.0 to 175.5
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Per/16/09 H3N2 [Day 28]
|
614.5 titre
Interval 371.4 to 1016.7
|
NA titre
No blood samples were collected at Day 28 on subjects from the Havrix Group for antibody determination.
|
SECONDARY outcome
Timeframe: At Day 0 and at Month 6Population: 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.
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).
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
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.
|
Havrix Group
n=37 Participants
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.
|
|---|---|---|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Day 0]
|
25.1 titre
Interval 19.7 to 32.1
|
NA titre
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria [Month 6]
|
199.5 titre
Interval 145.8 to 273.0
|
NA titre
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Day 0]
|
119.4 titre
Interval 94.5 to 150.8
|
138.3 titre
Interval 107.5 to 178.0
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1 [Month 6]
|
390.6 titre
Interval 291.4 to 523.8
|
115.3 titre
Interval 82.4 to 161.4
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Per/16/09 H3N2 [Day 0]
|
62.5 titre
Interval 49.5 to 78.8
|
NA titre
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Per/16/09 H3N2 [Month 6]
|
266.8 titre
Interval 173.6 to 410.1
|
NA titre
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
SECONDARY outcome
Timeframe: At Day 28Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=33 Participants
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.
|
Havrix Group
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.
|
|---|---|---|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
25 Subjects
|
—
|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1
|
29 Subjects
|
—
|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Per/16/09 H3N2
|
22 Subjects
|
—
|
SECONDARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
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.
|
Havrix Group
n=37 Participants
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.
|
|---|---|---|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu B/Bri/60/08 Victoria
|
28 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Cal/7/09 H1N1
|
13 Subjects
|
2 Subjects
|
|
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Flu A/Per/16/09 H3N2
|
17 Subjects
|
NA Subjects
Data for Havrix Group was presented only for the Flu A/California/7/2009 (H1N1) strain as per protocol.
|
SECONDARY outcome
Timeframe: Within 7 days (Day 0 - Day 6) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 swelling
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any pain
|
35 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 pain
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any redness
|
6 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 redness
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any swelling
|
5 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Within 7 days (Day 0 - Day 6) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any arthralgia
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 arthralgia
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any fatigue
|
25 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 fatigue
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any gastrointestinal symptoms
|
8 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 gastrointestinal symptoms
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any headache
|
24 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 headache
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any myalgia
|
16 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 myalgia
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any shivering
|
18 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 shivering
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any sweating
|
9 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 sweating
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Any temperature >= 37.5°C
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Grade 3 temperature > 39.0°C
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Within 7 days (Day 0 - Day 6) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
Solicited local symptoms assessed were pain, redness and swelling. Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Days With Any Solicited Local Symptoms.
Pain
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 2.5
|
|
Number of Days With Any Solicited Local Symptoms.
Redness
|
2.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local Symptoms.
Swelling
|
2.0 Days
Interval 2.0 to 3.0
|
0 Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Within 7 days (Day 0 - Day 6) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Days With Grade 3 Solicited Local Symptoms.
Pain
|
1.0 Days
Interval 1.0 to 1.0
|
0 Days
Interval 0.0 to 0.0
|
|
Number of Days With Grade 3 Solicited Local Symptoms.
Swelling
|
1.0 Days
Interval 1.0 to 1.0
|
0 Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Within 7 days (Day 0 - Day 6) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Days With Any Solicited General Symptoms.
Arthralgia
|
2.0 Days
Interval 1.5 to 4.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited General Symptoms.
Fatigue
|
2.0 Days
Interval 1.0 to 4.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited General Symptoms.
Gastrointestinal
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited General Symptoms.
Headache
|
2.0 Days
Interval to 3.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited General Symptoms.
Myalgia
|
2.0 Days
Interval 1.5 to 3.5
|
2.0 Days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited General Symptoms.
Sweating
|
1.0 Days
Interval 1.0 to 1.0
|
2.0 Days
Interval 2.0 to 2.5
|
|
Number of Days With Any Solicited General Symptoms.
Shivering
|
2.0 Days
Interval 1.0 to 4.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Number of Days With Any Solicited General Symptoms.
Temperature
|
1.0 Days
Interval 1.0 to 1.5
|
1.0 Days
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Within 7 days (Day 0 - Day 6) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Days With Grade 3 Solicited General Symptoms.
Myalgia
|
0 Days
Interval 0.0 to 0.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Number of Days With Grade 3 Solicited General Symptoms.
Fatigue
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Number of Days With Grade 3 Solicited General Symptoms.
Gastrointestinal
|
1.0 Days
Interval 1.0 to 1.0
|
0 Days
Interval 0.0 to 0.0
|
|
Number of Days With Grade 3 Solicited General Symptoms.
Headache
|
1.0 Days
Interval 1.0 to 1.0
|
0 Days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Within 28 days (Day 0 - Day 27) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Grade 3
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Related to vaccination
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Any
|
12 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) post-vaccination periodPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Medically-attended Events (MAEs).
|
1 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Up to Month 6)Population: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Medically-attended Events (MAEs).
|
2 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Up to Month 6)Population: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Up to Month 6)Population: The Total Vaccinated cohort included all vaccinated subjects.
Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events of Special Interest.
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) post-vaccination periodPopulation: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Up to Month 6)Population: The Total Vaccinated cohort included all vaccinated subjects.
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.
Outcome measures
| Measure |
Fluarix Group
n=38 Participants
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.
|
Havrix Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
1 Subjects
|
0 Subjects
|
Adverse Events
Fluarix Group
Havrix Group
Serious adverse events
| Measure |
Fluarix Group
n=38 participants at risk
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.
|
Havrix Group
n=39 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Acute tonsillitis
|
2.6%
1/38 • 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.
|
0.00%
0/39 • 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.
|
Other adverse events
| Measure |
Fluarix Group
n=38 participants at risk
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.
|
Havrix Group
n=39 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
3/38 • 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.
|
5.1%
2/39 • 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.
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • 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.
|
5.1%
2/39 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/38 • 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.
|
5.1%
2/39 • 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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
2/38 • 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.
|
0.00%
0/39 • 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.
|
|
General disorders
Pain
|
92.1%
35/38 • 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.
|
61.5%
24/39 • 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.
|
|
General disorders
Redness
|
15.8%
6/38 • 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.
|
12.8%
5/39 • 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.
|
|
General disorders
Swelling
|
13.2%
5/38 • 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.
|
0.00%
0/39 • 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.
|
|
General disorders
Arthralgia
|
10.5%
4/38 • 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.
|
12.8%
5/39 • 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.
|
|
General disorders
Fatigue
|
65.8%
25/38 • 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.
|
61.5%
24/39 • 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.
|
|
General disorders
Gastrointestinal symptoms
|
21.1%
8/38 • 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.
|
7.7%
3/39 • 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.
|
|
General disorders
Headache
|
63.2%
24/38 • 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.
|
41.0%
16/39 • 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.
|
|
General disorders
Myalgia
|
42.1%
16/38 • 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.
|
41.0%
16/39 • 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.
|
|
General disorders
Shivering
|
47.4%
18/38 • 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.
|
23.1%
9/39 • 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.
|
|
General disorders
Sweating
|
23.7%
9/38 • 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.
|
10.3%
4/39 • 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.
|
|
General disorders
Temperature
|
10.5%
4/38 • 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.
|
2.6%
1/39 • 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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER