InfluenzaPhase 3NCT00938392

Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly

A Phase 3 study testing GSK investigational FluNG vaccine GSK2186877A, aged lot and GSK investigational FluNG vaccine GSK2186877A, fresh lot in people with Influenza, run by GlaxoSmithKline at 6 sites in 2 countries.

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

The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: GSK investigational FluNG vaccine GSK2186877A, aged lot and GSK investigational FluNG vaccine GSK2186877A, fresh lot
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 726 participants
Where: 6 sitesin 2 countries
Study dates: 30 Jul 2009to 5 Oct 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 65 years and older
All sexes
Healthy volunteers accepted
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. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
A man or woman 65 years of age or older at the time of vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

Who cannot join

Any confirmed or suspected influenza illness within the last 6 months.
Previous vaccination against influenza with any seasonal vaccine since December 2008.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.

Show all 14Show fewer

Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature >= 37.5°C on oral setting.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Any medical conditions in which intramuscular injections are contraindicated.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

Slovakia4 sites

GSK Investigational Site
Bratislava, 811 03
GSK Investigational Site
Bratislava, 814 66
GSK Investigational Site
Bratislava, 841 04
GSK Investigational Site
Veľký Biel, 900 24

Other trials in Slovakia

Estonia2 sites

GSK Investigational Site
Tallinn
GSK Investigational Site
Tartu, 50106

Other trials in Estonia

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.

The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.

Conditions: Influenza
Being tested: GSK investigational FluNG vaccine GSK2186877A, aged lot, GSK investigational FluNG vaccine GSK2186877A, fresh lot
Keywords: influenza infection, GSK Bio's influenza vaccine GSK2186877A
Medical subject headings: Influenza, Human

What participants receive

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

GSK investigational FluNG vaccine GSK2186877A, aged lotBiological
Single dose, intramuscular injection
GSK investigational FluNG vaccine GSK2186877A, fresh lotBiological
Single dose, intramuscular injection

Study groups in NCT00938392
Study group	Role	What they receive
FluNG Aged Group	Experimental	Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). Receives: Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot
FluNG Fresh Group	Experimental	Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). Receives: Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot

What is being measured

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

Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Measured: At Days 0 and 21

Secondary outcomes (9)

Number of Subjects Seropositive Against the 3 Vaccine Strains
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Measured: At Days 0 and 21
Number of Subjects Seroconverted for the 3 Vaccine Strains
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Measured: At Day 21
Seroconversion Factor for the 3 Vaccine Strains
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Measured: At Day 21
Number of Subjects Seroprotected for the 3 Vaccine Strains
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Measured: At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 7-day post-vaccination period
Duration of Solicited Local and General Symptoms
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.
Measured: During the 7-day post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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.
Measured: During the 21-day post-vaccination period
Number of Subjects Reporting Adverse Events of Specific Interest (AESI)
AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.
Measured: During the 21-day post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the entire study period (up to Day 21)

Timeline

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

30 Jul 20095 Oct 2009

First posted13 Jul 2009 (estimated)
Study start30 Jul 2009
Primary completion5 Oct 2009
Study completion5 Oct 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 726 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00938392
Sponsor's protocol ID: 112662
Status last verified: May 2018
First submitted: 9 Jul 2009
Last updated: 20 Aug 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 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.
ClinicalTrials.gov ID: NCT00938392
Acronym / sponsor ID: 112662
Conditions: Influenza
Keywords: influenza infection, GSK Bio's influenza vaccine GSK2186877A
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 726 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Jul 2009
Primary completion: 5 Oct 2009 (actual)
Study completion: 5 Oct 2009 (actual)
First posted: 13 Jul 2009 (estimated)
Results: Posted 17 May 2012

Clinical summary

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

The objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FluNG Aged Group	Experimental	Biological: GSK investigational FluNG vaccine GSK2186877A, aged lotSubjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
FluNG Fresh Group	Experimental	Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lotSubjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
A man or woman 65 years of age or older at the time of vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.

Key exclusion criteria (14 listed)

Any confirmed or suspected influenza illness within the last 6 months.
Previous vaccination against influenza with any seasonal vaccine since December 2008.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2.

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
GSK investigational FluNG vaccine GSK2186877A, aged lotSingle dose, intramuscular injection	Biological	FluNG Aged Group
GSK investigational FluNG vaccine GSK2186877A, fresh lotSingle dose, intramuscular injection	Biological	FluNG Fresh Group

Primary outcome

Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
Time frame: At Days 0 and 21
Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.

9 secondary outcomes

Number of Subjects Seropositive Against the 3 Vaccine Strains
Time frame: At Days 0 and 21
Number of Subjects Seroconverted for the 3 Vaccine Strains
Time frame: At Day 21
Seroconversion Factor for the 3 Vaccine Strains
Time frame: At Day 21
Number of Subjects Seroprotected for the 3 Vaccine Strains
Time frame: At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day post-vaccination period
Duration of Solicited Local and General Symptoms
Time frame: During the 7-day post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 21-day post-vaccination period
Number of Subjects Reporting Adverse Events of Specific Interest (AESI)
Time frame: During the 21-day post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the entire study period (up to Day 21)

Results and safety

Results posted to the registry on 17 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FluNG Aged Group	362	360
FluNG Fresh Group	362	358

Primary outcome: Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains

Time frame: At Days 0 and 21. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	FluNG Aged Group n = 357	FluNG Fresh Group n = 355
A/Brisbane [Day 0]	14.1 (12.7 to 15.8)	13.4 (12.1 to 14.9)
A/Brisbane [Day 21]	108.4 (95.8 to 122.6)	108.7 (95.1 to 124.1)
A/Uruguay [Day 0]	18.5 (16.1 to 21.3)	19.1 (16.7 to 21.8)
A/Uruguay [Day 21]	291.5 (251.9 to 337.4)	282.7 (244.6 to 326.8)
B/Brisbane [Day 0]	68.2 (59.3 to 78.4)	62.3 (54.8 to 70.7)
B/Brisbane [Day 21]	537.9 (483.6 to 598.3)	534.2 (483.5 to 590.3)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FluNG Aged Group	1 of 362 (0.3%)	242 of 362 (66.9%)	Not reported
FluNG Fresh Group	1 of 362 (0.3%)	252 of 362 (69.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Slovakia, Estonia. 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 17 May 2012). 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?

Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains (time frame: At Days 0 and 21). 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 NCT00938392.

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 20 Aug 2018.