Clinical Trial Results:
A Phase IV, open label, randomized, monocentric study to evaluate immunogenicity and safety of GSK Biologicals' seasonal (2010-2011) influenza vaccine FluarixTM in adolescents previously vaccinated with GSK Biologicals' H1N1 vaccine (PandemrixTM).
Summary
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EudraCT number |
2010-020331-39 |
Trial protocol |
FI |
Global end of trial date |
07 Jul 2011
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Results information
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Results version number |
v3(current) |
This version publication date |
07 Jul 2022
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First version publication date |
07 Mar 2015
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Other versions |
v1 , v2 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
114452
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01190215 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue Fleming 20, Wavre, Belgium, 1300
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Sep 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Jul 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Jul 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate HI immune response against the H1N1 strain 28 days following vaccination with TIV vaccine (Fluarix) in subjects previously vaccinated with 1 dose of H1N1 adjuvanted vaccine (Pandemrix) in the TIV Group.
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Protection of trial subjects |
All subjects were supervised for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated. Subjects were followed-up until Month 6 after each/last vaccination.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Dec 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 77
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Worldwide total number of subjects |
77
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EEA total number of subjects |
77
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
77
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
Pre-assignment
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Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | |||||||||||||||
Period 1
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Period 1 title |
Up to Day 28
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fluarix Group | |||||||||||||||
Arm 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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Biological: Fluarix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One Intramuscular injection
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Arm title
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Havrix Group | |||||||||||||||
Arm description |
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. | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Biological: Havrix Junior
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Two Intramuscular injections
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Period 2
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Period 2 title |
Up to Month 6
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fluarix Group | |||||||||||||||
Arm 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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Biological: Fluarix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
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.
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Investigational medicinal product name |
Biological: Havrix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
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.
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Arm title
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Havrix Group | |||||||||||||||
Arm description |
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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Biological: Havrix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
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.
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Baseline characteristics reporting groups
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Reporting group title |
Fluarix Group
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Havrix Group
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fluarix Group
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Reporting 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. | ||
Reporting group title |
Havrix Group
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Reporting group description |
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. | ||
Reporting group title |
Fluarix Group
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Reporting 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. | ||
Reporting group title |
Havrix Group
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Reporting group description |
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. |
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End point title |
Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [1] | ||||||||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
At Day 0 and Day 28
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [2] | |||||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
At Day 0 and Day 28
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [3] [4] | ||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
At Day 28
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Day 28 data were presented for the Fluarix Group only. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [5] | |||||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
At Day 0 and Day 28
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [6] [7] | ||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
At Day 28
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Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted. [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Day 28 data were presented for the Fluarix Group only. |
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No statistical analyses for this end point |
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End point title |
Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | ||||||||||||||||||||||||||||||
End point 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). Only data for the Flu
A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 28
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No statistical analyses for this end point |
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End point title |
Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | ||||||||||||||||||||||||||||||
End point 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).
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End point type |
Secondary
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End point timeframe |
At Day 0 and at Month 6
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No statistical analyses for this end point |
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End point title |
Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | |||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 28
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No statistical analyses for this end point |
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End point title |
Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | |||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Day 0 and at Month 6
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. [8] | ||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Day 28
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Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Day 28 data were presented for the Fluarix Group only. |
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | ||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Month 6
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | |||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 28
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | |||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Month 6
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No statistical analyses for this end point |
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End point title |
Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. [9] | ||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Day 28
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Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Day 28 data were presented for the Fluarix Group only. |
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No statistical analyses for this end point |
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End point title |
Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. | |||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
At Month 6
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|
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No statistical analyses for this end point |
|
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End point title |
Geometric mean antibody titres for neutralising antibodies against all Fluarix vaccine strains. | ||||||||||||||||||||||||||||||
End point 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).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
At Day 0 and at Day 28
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Geometric mean antibody titres for neutralising antibodies against all Fluarix vaccine strains. | ||||||||||||||||||||||||||||||
End point 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). Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
At Day 0 and at Month 6
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of seroconverted subjects for neutralising antibodies against all Fluarix vaccine strains. [10] | ||||||||||||
End point 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Day 28
|
||||||||||||
Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Day 28 data were presented for the Fluarix Group only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of seroconverted subjects for neutralising antibodies against all Fluarix vaccine strains. | ||||||||||||||||||
End point 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.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
At Month 6
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects reporting any and Grade 3 solicited local symptoms. | |||||||||||||||||||||||||||
End point 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.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Within 7 days (Day 0 – Day 6) after vaccination
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects reporting any and Grade 3 solicited general symptoms. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point 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.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Within 7 days (Day 0 – Day 6) after vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of days with any solicited local symptoms. | |||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling. Inter-quartile range assessed was the 25th percentile and the 75th percentile.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Within 7 days (Day 0 – Day 6) after vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of days with grade 3 solicited local symptoms. | ||||||||||||||||||
End point 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.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Within 7 days (Day 0 – Day 6) after vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Number of days with any solicited general symptoms. | ||||||||||||||||||||||||||||||||||||
End point 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.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Within 7 days (Day 0 – Day 6) after vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of days with grade 3 solicited general symptoms. | ||||||||||||||||||||||||
End point 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.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Within 7 days (Day 0 – Day 6) after vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs). | ||||||||||||||||||
End point 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.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Within 28 days (Day 0 – Day 27) after vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting medically-attended events (MAEs). | ||||||||||||
End point 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within the 28-day (Days 0-27) post-vaccination period
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting medically-attended events (MAEs). | ||||||||||||
End point 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the entire study period (Up to Month 6)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting adverse events of specific interest (AESIs)/potential immune mediated diseases (pIMDs). | ||||||||||||
End point 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the entire study period (Up to Month 6)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting adverse events of special interest. | ||||||||||||
End point description |
Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the entire study period (Up to Month 6)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting serious adverse events (SAEs). | ||||||||||||
End point 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within the 28-day (Days 0-27) post-vaccination period
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting serious adverse events (SAEs). | ||||||||||||
End point 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the entire study period (Up to Month 6)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
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.
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
|
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Reporting groups
|
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Reporting group title |
Havrix Group
|
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluarix Group
|
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |