Clinical Trial Results:
A Phase III, open-label, non-randomised, multi-centre, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2013/2014 injected intramuscularly in adults (18 to 60 years of age) and in the elderly (over 60 years of age)
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Summary
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EudraCT number |
2013-000855-42 |
Trial protocol |
DE |
Global end of trial date |
02 Aug 2013
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Results information
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Results version number |
v3(current) |
This version publication date |
06 Jun 2022
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First version publication date |
19 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 |
200160
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01884519 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Aug 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Aug 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Aug 2013
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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 the humoral response [anti- Haemagglutinin (HA) antibodies tested by Haemagglutination Inhibition (HI)] against each vaccine strain in adults 18-60 years and >60 years of age, 21 days after vaccination with Fluarix/Influsplit SSW 2013/2014.
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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 for xx days after each/last vaccination.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Jul 2013
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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 |
Germany: 120
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Worldwide total number of subjects |
120
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EEA total number of subjects |
120
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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) |
0
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Adults (18-64 years) |
120
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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 |
- | |||||||||
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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. | |||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fluarix/Influsplit 18-60 Years Group | |||||||||
Arm description |
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Fluarix/Influsplit SSW® (2013-2014 season)
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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 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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Arm title
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Fluarix/Influsplit > 60 Years Group | |||||||||
Arm description |
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Fluarix/Influsplit SSW® (2013-2014 season)
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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 above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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Baseline characteristics reporting groups
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Reporting group title |
Fluarix/Influsplit 18-60 Years Group
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Reporting group description |
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluarix/Influsplit > 60 Years Group
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Reporting group description |
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fluarix/Influsplit 18-60 Years Group
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Reporting group description |
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | ||
Reporting group title |
Fluarix/Influsplit > 60 Years Group
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Reporting group description |
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. | ||
Subject analysis set title |
Fluarix/Influsplit > 60 Years Group with Vaccination
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects aged >60 years of age receiving Fluarix/Influsplit SSW 2013-2014
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Subject analysis set title |
Fluarix/Influsplit > 60 Years Group without Vaccination
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects aged >60 years of age not receiving Fluarix/Influsplit SSW 2013-2014
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Subject analysis set title |
Fluarix/Influsplit 18-60 years Group with Vaccination
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Fluarix/Influsplit 18-60 years Group with Vaccination: Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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Subject analysis set title |
Fluarix/Influsplit 18-60 years Group without Vaccination
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Fluarix/Influsplit 18-60 years Group without Vaccination: Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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End point title |
Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against each of the three vaccine influenza strains [1] | ||||||||||||||||||||||||||||||
End point description |
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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End point type |
Primary
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End point timeframe |
At Day 0 and Day 21
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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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Number of subjects who were seroprotected for anti-HI antibodies against each of the three vaccine influenza strains. [2] | |||||||||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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End point type |
Primary
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End point timeframe |
At Day 0 and Day 21
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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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Number of seroconverted subjects for anti-HA antibodies against each of the three vaccine influenza strains. [3] | ||||||||||||||||||
End point description |
A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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End point type |
Primary
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End point timeframe |
At Day 21
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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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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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) antibody titer against each of the three vaccine influenza strains. [4] | |||||||||||||||||||||
End point description |
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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End point type |
Primary
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End point timeframe |
At Day 21
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| Notes [4] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number of subjects with seroprotection power (SPP) for HI antibody titer against each of the three vaccine Influenza strains above the cut-off value. [5] | ||||||||||||||||||
End point description |
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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End point type |
Primary
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End point timeframe |
At Day 21
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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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Humoral immune response in terms of HI antibody titers against each of the three vaccine influenza strains | ||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
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End point type |
Secondary
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End point timeframe |
At Days 0 and 21
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects who were seroprotected for anti-HI antibodies against each of the three vaccine influenza strains. | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
A seroprotected subject was defined as the number of a vaccinated subjects with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 21
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of seroconverted subjects for anti-HA antibodies against each of the three vaccine influenza strains. | ||||||||||||||||||||||||||||||
End point description |
A seroconverted subjects was defined as a vaccinated subjects with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
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End point type |
Secondary
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End point timeframe |
At Day 21
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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) antibody titer against each of the three vaccine influenza strains. | |||||||||||||||||||||||||||||||||||
End point description |
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
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End point type |
Secondary
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End point timeframe |
At Day 21
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects reporting any and grade 3 solicited local symptoms. | |||||||||||||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
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End point title |
Duration of solicited local symptoms. | ||||||||||||||||||||||||
End point description |
Duration was defined as number of days with any grade of local symptoms.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Number of subjects reporting any, grade 3 and related solicited general symptoms. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Duration of solicited general symptoms. | ||||||||||||||||||||||||||||||||||||
End point description |
Duration was defined as number of days with any grade of general symptoms.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs) | ||||||||||||||||||
End point description |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
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End point type |
Secondary
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End point timeframe |
During the 21-day (Days 0-20) post-vaccination period
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of subjects reporting any and related serious adverse events (SAEs) | |||||||||||||||
End point description |
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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End point type |
Secondary
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End point timeframe |
During the entire study period (Days 0-180)
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period
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Adverse event reporting additional description |
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Fluarix/Influsplit > 60 Years Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluarix/Influsplit 18-60 Years Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
