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CompletedNCT00706563Updated Aug 17, 2018Results posted

A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults

A Phase 3 interventional study of Fluarix™ in Influenza, sponsored by GlaxoSmithKline. Completed at 5 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2008-2009 season.

02

Conditions studied

  • Influenza
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female aged 18 years or above at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Administration of an influenza vaccine within 1 year preceding the study start.
  • Administration of an influenza vaccine other than the study vaccine during the entire study
  • Clinically or virologically confirmed influenza infection within 1 year preceding the study start
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Not stabilized or clinically serious chronic underlying disease.
  • Lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Fluarix Adult Group

    Subjects who are 18-40 years of age received one dose of Fluarix™.

    Biological: Fluarix™

  • Experimental
    Fluarix Elderly Group

    Subjects who are ≥ 60 years of age received one dose of Fluarix™.

    Biological: Fluarix™

Interventions

  • BiologicalFluarix™

    Single intramuscular dose on Day 0

    Also known as: Influsplit

06

What researchers measure

Primary outcomes

  1. Hemagglutination Inhibition (HI) Antibody Titer

    Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

    Time frame: At Day 0 and 21

  2. Number of Subjects With HI Antibody Titer Above the Cut-off Value

    The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains

    Time frame: At Day 0 and 21

  3. Number of Seroprotected Subjects

    A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

    Time frame: At Day 0 and 21

  4. Number of Serconverted Subjects

    A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4

    Time frame: At Day 21

  5. Serconversion Factor

    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

    Time frame: At Day 21

  6. Seroprotection Power

    Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40

    Time frame: At Day 21

Secondary outcomes

  1. Number of Subjects Reporting Solicited Symptoms

    Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever

    Time frame: During the 4-day (Day 0-3) post-vaccination period

  2. Number of Subjects Reporting Unsolicited Adverse Events (AE)

    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.

    Time frame: During the 21-day (Day 0-20) post-vaccination period

  3. Number of Subjects Reporting Serious Adverse Events (SAE)

    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.

    Time frame: During the 21-day (Day 0-20) post-vaccination period

07

Results

Posted Aug 25, 2009

Participant flow

Participant flow — Overall Study
MilestoneFluarix Adult GroupFluarix Elderly Group
Started6159
Completed6159
Not completed00

Outcome measures

PrimaryHemagglutination Inhibition (HI) Antibody Titer

Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

Time frame:
At Day 0 and 21
Reported as:
Geometric mean · titer
Hemagglutination Inhibition (HI) Antibody Titer
titerFluarix Adult GroupFluarix Elderly Group
A/Brisbane (Day 0)13.6 (10.1 to 18.2)11.6 (9.1 to 14.9)
A/Brisbane (Day 21)165.5 (119.2 to 229.7)68.2 (48.4 to 96.3)
A/Uruguay (Day 0)7.6 (6.2 to 9.3)9.7 (7.3 to 12.9)
A/Uruguay (Day 21)90.7 (60.2 to 136.5)120.6 (76.1 to 191.0)
B/Brisbane (Day 0)102.1 (74.4 to 140.0)108.0 (76.9 to 151.8)
B/Brisbane (Day 21)785.3 (634.0 to 972.7)524.0 (404.9 to 678.2)
PrimaryNumber of Subjects With HI Antibody Titer Above the Cut-off Value

The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains

Time frame:
At Day 0 and 21
Reported as:
Number · subjects
Number of Subjects With HI Antibody Titer Above the Cut-off Value
subjectsFluarix Adult GroupFluarix Elderly Group
A/Brisbane (Day 0)3635
A/Brisbane (Day 21)6158
A/Uruguay (Day 0)1923
A/Uruguay (Day 21)5758
B/Brisbane (Day 0)6058
B/Brisbane (Day 21)6159
PrimaryNumber of Seroprotected Subjects

A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

Time frame:
At Day 0 and 21
Reported as:
Number · subjects
Number of Seroprotected Subjects
subjectsFluarix Adult GroupFluarix Elderly Group
A/Brisbane (Day 0)159
A/Brisbane (Day 21)5540
A/Uruguay (Day 0)58
A/Uruguay (Day 21)4743
B/Brisbane (Day 0)4850
B/Brisbane (Day 21)6159
PrimaryNumber of Serconverted Subjects

A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4

Time frame:
At Day 21
Reported as:
Number · subjects
Number of Serconverted Subjects
subjectsFluarix Adult GroupFluarix Elderly Group
A/Brisbane4430
A/Uruguay4439
B/Brisbane3930
PrimarySerconversion Factor

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

Time frame:
At Day 21
Reported as:
Number · factor
Serconversion Factor
factorFluarix Adult GroupFluarix Elderly Group
A/Brisbane12.25.9
A/Uruguay12.012.4
B/Brisbane7.74.9
PrimarySeroprotection Power

Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40

Time frame:
At Day 21
Reported as:
Number · subjects
Seroprotection Power
subjectsFluarix Adult GroupFluarix Elderly Group
A/Brisbane (N=46; 50)4032
A/Uruguay (N=56; 51)4235
B/Brisbane (N=13; 9)139
SecondaryNumber of Subjects Reporting Solicited Symptoms

Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever

Time frame:
During the 4-day (Day 0-3) post-vaccination period
Reported as:
Number · subjects
Number of Subjects Reporting Solicited Symptoms
subjectsFluarix Adult GroupFluarix Elderly Group
Ecchymosis30
Induration197
Pain3622
Redness2411
Swelling166
Arthralgia62
Fatigue108
Headache88
Myalgia157
Shivering45
Sweating54
Fever00
SecondaryNumber of Subjects Reporting Unsolicited Adverse Events (AE)

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.

Time frame:
During the 21-day (Day 0-20) post-vaccination period
Reported as:
Number · subjects
Number of Subjects Reporting Unsolicited Adverse Events (AE)
subjectsFluarix Adult GroupFluarix Elderly Group
Number of Subjects Reporting Unsolicited Adverse Events (AE)76
SecondaryNumber of Subjects Reporting Serious Adverse Events (SAE)

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.

Time frame:
During the 21-day (Day 0-20) post-vaccination period
Reported as:
Number · subjects
Number of Subjects Reporting Serious Adverse Events (SAE)
subjectsFluarix Adult GroupFluarix Elderly Group
Number of Subjects Reporting Serious Adverse Events (SAE)10

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fluarix Adult Group—1/61 (1.6%)44/61 (72.1%)
Fluarix Elderly Group—0/59 (0%)30/59 (50.8%)
Most frequent serious events
Most frequent serious events
EventFluarix Adult GroupFluarix Elderly Group
Chest painGeneral disorders1/610/59
Most frequent other events
Most frequent other events
EventFluarix Adult GroupFluarix Elderly Group
PainGeneral disorders36/6122/59
RednessGeneral disorders24/6111/59
IndurationGeneral disorders19/617/59
SwellingGeneral disorders16/616/59
MyalgiaGeneral disorders15/617/59
FatigueGeneral disorders10/618/59
HeadacheGeneral disorders8/618/59
ArthralgiaGeneral disorders6/612/59
ShiveringGeneral disorders4/615/59
SweatingGeneral disorders5/614/59

Baseline characteristics

Age, Continuous
Age, Continuous(years)Fluarix Adult GroupFluarix Elderly GroupTotal
Mean39.1 ± 13.2668.8 ± 5.2553.7 ± 18.01
Sex: Female, Male
Sex: Female, Male(Participants)Fluarix Adult GroupFluarix Elderly GroupTotal
Female363470
Male252550
08

Study locations

5 sites
  • GSK Investigational Site
    Dresden, Sachsen 01097, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01099, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01129, Germany
  • GSK Investigational Site
    Dresden, Sachsen 01277, Germany
  • GSK Investigational Site
    Freital, Sachsen 01705, Germany
09

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00706563
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 27, 2008
Start date
Jul 7, 2008
Primary completion
Jul 30, 2008
Completion
Jul 30, 2008
Results posted
Aug 25, 2009
Last update
Aug 17, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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