Clinical Trial Results:
A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ / Influsplit SSW® 2009/2010 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years).
Summary
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EudraCT number |
2009-010811-34 |
Trial protocol |
DE |
Global end of trial date |
08 Jul 2009
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Results information
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Results version number |
v1 |
This version publication date |
11 May 2016
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First version publication date |
04 Dec 2014
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Other versions |
v2 |
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 |
113018
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00920374 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium,
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Jul 2009
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Jul 2009
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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-hemagglutinin antibody tested by hemagglutination inhibition) against each vaccine strain in adults aged 18 years or above, 21 days after vaccination with Fluarix™/Influsplit SSW® 2009-2010.
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Protection of trial subjects |
As with all injectable vaccines, appropriate medical treatment was always readily available in case of rare anaphylactic reactions following the administration of the vaccine.
For this reason, the vaccine remained under medical supervision for 30 minutes after vaccination.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Jun 2009
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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: 118
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Worldwide total number of subjects |
118
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EEA total number of subjects |
118
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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) |
61
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From 65 to 84 years |
57
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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 |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
118 | |||||||||
Number of subjects completed |
118 | |||||||||
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 | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Fluarix Adult Group | |||||||||
Arm description |
Subjects who are 18-60 years of age received one dose of Fluarix™ | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Fluarix™/Influsplit SSW®
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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 and intravenous use
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Dosage and administration details |
single intramuscular dose on Day 0
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Arm title
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Fluarix Elderly Group | |||||||||
Arm description |
Subjects who are > 60 years of age received one dose of Fluarix™ | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Fluarix™/Influsplit SSW®
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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 |
single intramuscular dose on Day 0
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Baseline characteristics reporting groups
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Reporting group title |
Fluarix Adult Group
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Reporting group description |
Subjects who are 18-60 years of age received one dose of Fluarix™ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluarix Elderly Group
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Reporting group description |
Subjects who are > 60 years of age received one dose of Fluarix™ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fluarix Adult Group
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Reporting group description |
Subjects who are 18-60 years of age received one dose of Fluarix™ | ||
Reporting group title |
Fluarix Elderly Group
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Reporting group description |
Subjects who are > 60 years of age received one dose of Fluarix™ |
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End point title |
Hemagglutination Inhibition (HI) Antibody Titre [1] | ||||||||||||||||||||||||||||||
End point description |
Titres given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
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End point type |
Primary
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End point timeframe |
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 With HI Antibody Titre Above the Cut-off Value [2] | |||||||||||||||||||||||||||
End point description |
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
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End point type |
Primary
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End point timeframe |
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 Seroprotected Subjects [3] | |||||||||||||||||||||||||||
End point description |
A seroprotected subject is a subject with a serum HI antibody titre ≥ 1:40
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End point type |
Primary
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End point timeframe |
Day 0 and 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 |
Number of Seroconverted Subjects [4] | ||||||||||||||||||
End point description |
A seroconverted subject is a subject with a pre-vaccination serum HI titre< 1:10 and a post-vaccination serum HI titre ≥ 1:40, or a pre-vaccination serum HI titre ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
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End point type |
Primary
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End point timeframe |
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 |
Seroconversion Factor [5] | |||||||||||||||||||||
End point description |
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
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End point type |
Primary
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End point timeframe |
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 |
Seroprotection Power [6] | ||||||||||||||||||
End point description |
Seroprotection power is defined as the number of subject who had a pre-vaccination titre < 1:40 and a post-vaccination titre ≥ 1:40
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End point type |
Primary
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End point timeframe |
Day 21
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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 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 Reporting Solicited Local Symptoms | ||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Day 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 Solicited General Symptoms | ||||||||||||||||||||||||||||||
End point description |
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever
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End point type |
Secondary
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End point timeframe |
During the 4-day (Day 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 Unsolicited Adverse Events (AE) | ||||||||||||
End point description |
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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End point type |
Secondary
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End point timeframe |
During the 21-day (Day 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 Serious Adverse Events (SAE) | ||||||||||||
End point description |
An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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End point type |
Secondary
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End point timeframe |
During the entire study period
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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 21; 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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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 Adult Group
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Reporting group description |
Subjects who are 18-60 years of age received one dose of Fluarix™ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluarix Elderly Group
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Reporting group description |
Subjects who are > 60 years of age received one dose of Fluarix™ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |