InfluenzaPhase 3NCT00920374

A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults

A Phase 3 study testing Fluarix™/Influsplit SSW® in people with Influenza, run by GlaxoSmithKline at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluarix™/Influsplit SSW®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 5 sitesGermany
Study dates: 16 Jun 2009to 8 Jul 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
Chronic administration 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 6 months 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 6 months preceding the study start

Show all 14Show fewer

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

GSK Investigational Site
Dresden, Saxony, 01097
GSK Investigational Site
Dresden, Saxony, 01099
GSK Investigational Site
Dresden, Saxony, 01129
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Freital, Saxony, 01705

Other trials in Germany

About this study

Official title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in People Aged 18 Years or Above

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.

Conditions: Influenza
Being tested: Fluarix™/Influsplit SSW®
Keywords: Influenza
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluarix™/Influsplit SSW®Biological
single intramuscular dose on Day 0

Study groups in NCT00920374
Study group	Role	What they receive
Fluarix Adult Group	Experimental	Subjects who are 18-60 years of age received one dose of Fluarix™ Receives: Biological: Fluarix™/Influsplit SSW®
Fluarix Elderly Group	Experimental	Subjects who are > 60 years of age received one dose of Fluarix™ Receives: Biological: Fluarix™/Influsplit SSW®

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemagglutination Inhibition (HI) Antibody Titer
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Measured: Day 0 and Day 21
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
Measured: Day 0 and Day 21
Number of Seroprotected Subjects
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
Measured: Day 0 and Day 21
Number of Seroconverted 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
Measured: Day 21
Seroconversion 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
Measured: Day 21
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
Measured: Day 21

Secondary outcomes (4)

Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
Measured: During the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever
Measured: During the 4-day (Day 0-3) post-vaccination period
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.
Measured: During the 21-day (Day 0-20) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, 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.
Measured: During the entire study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 20098 Jul 2009

First posted15 Jun 2009 (estimated)
Study start16 Jun 2009
Primary completion8 Jul 2009
Study completion8 Jul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00920374
Sponsor's protocol ID: 113018
Status last verified: Oct 2016
First submitted: 12 Jun 2009
Last updated: 21 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in People Aged 18 Years or Above
ClinicalTrials.gov ID: NCT00920374
Acronym / sponsor ID: 113018
Conditions: Influenza
Keywords: Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Jun 2009
Primary completion: 8 Jul 2009 (actual)
Study completion: 8 Jul 2009 (actual)
First posted: 15 Jun 2009 (estimated)
Results: Posted 27 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fluarix Adult Group	Experimental	Biological: Fluarix™/Influsplit SSW®Subjects who are 18-60 years of age received one dose of Fluarix™
Fluarix Elderly Group	Experimental	Biological: Fluarix™/Influsplit SSW®Subjects who are > 60 years of age received one dose of Fluarix™

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
Chronic administration 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 6 months preceding the study start.
Administration of an influenza vaccine other than the study vaccine during the entire study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluarix™/Influsplit SSW®single intramuscular dose on Day 0	Biological	Fluarix Adult Group, Fluarix Elderly Group

Primary outcome

Hemagglutination Inhibition (HI) Antibody Titer
Time frame: Day 0 and Day 21
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Number of Subjects With HI Antibody Titer Above the Cut-off Value
Time frame: Day 0 and Day 21
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
Number of Seroprotected Subjects
Time frame: Day 0 and Day 21
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
Number of Seroconverted Subjects
Time frame: Day 21
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
Seroconversion Factor
Time frame: Day 21
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
Seroprotection Power
Time frame: Day 21
Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40

4 secondary outcomes

Number of Subjects Reporting Solicited Local Symptoms
Time frame: During the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Time frame: During the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time frame: During the 21-day (Day 0-20) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
Time frame: During the entire study period

Results and safety

Results posted to the registry on 27 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluarix Adult Group	61	61
Fluarix Elderly Group	57	57

Primary outcome: Hemagglutination Inhibition (HI) Antibody Titer

Time frame: Day 0 and Day 21. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Fluarix Adult Group n = 59	Fluarix Elderly Group n = 56
A/Brisbane (Day 0)	15.5 (11.7 to 20.6)	11.4 (9.2 to 14.0)
A/Brisbane (Day 21)	139.7 (100.6 to 194.0)	55.8 (39.2 to 79.5)
A/Uruguay (Day 0)	18.2 (13.7 to 24.1)	13.2 (10.1 to 17.2)
A/Uruguay (Day 21)	151.7 (111.6 to 206.2)	112.4 (76.3 to 165.5)
B/Brisbane (Day 0)	62.8 (45.4 to 86.8)	77.6 (57.3 to 105.0)
B/Brisbane (Day 21)	393.0 (319.3 to 483.7)	371.3 (274.9 to 501.6)

Population analysed: Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data

Primary outcome: Number of Subjects With HI Antibody Titer Above the Cut-off Value

Time frame: Day 0 and Day 21. Count of participants. Unit: Participants

Measure	Fluarix Adult Group n = 59	Fluarix Elderly Group n = 56
A/Brisbane (Day 0)	39	36
A/Brisbane (Day 21)	58	56
A/Uruguay (Day 0)	44	37
A/Uruguay (Day 21)	59	56
B/Brisbane (Day 0)	56	54
B/Brisbane (Day 21)	59	56

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data

Primary outcome: Number of Seroprotected Subjects

Time frame: Day 0 and Day 21. Count of participants. Unit: Participants

Measure	Fluarix Adult Group n = 59	Fluarix Elderly Group n = 56
A/Brisbane (Day 0)	18	6
A/Brisbane (Day 21)	53	35
A/Uruguay (Day 0)	17	10
A/Uruguay (Day 21)	52	46
B/Brisbane (Day 0)	38	45
B/Brisbane (Day 21)	59	56

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data

Primary outcome: Number of Seroconverted Subjects

Time frame: Day 21. Count of participants. Unit: Participants

Measure	Fluarix Adult Group n = 59	Fluarix Elderly Group n = 56
A/Brisbane	41	24
A/Uruguay	40	41
B/Brisbane	34	30

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluarix Adult Group	0 of 61 (0%)	47 of 61 (77%)	Not reported
Fluarix Elderly Group	0 of 57 (0%)	31 of 57 (54.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluarix™/Influsplit SSW® in people with Influenza, run by GlaxoSmithKline at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemagglutination Inhibition (HI) Antibody Titer (time frame: Day 0 and Day 21). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00920374.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.