InfluenzaPhase 2NCT00363077

Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

A Phase 2 study testing GSK1247446A Group and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.

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 purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: GSK1247446A Group and Fluarix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteBelgium
Study dates: 2 Oct 2006to 17 Nov 2006
Phase: Phase 2
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 60 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 wil comply with the requirements of the protocol should be enrolled in the study.
A male or female 60 years or older at the time of the first vaccination.
Free of obvious health problems

Who cannot join

Use of non-registered products
Administration of immune-modifying drugs.
Administration of vaccine 30 days before enrolment in study.
Immunosuppressive or immunodeficient condition.
Hypersensitivity to a previous dose of influenza vaccine
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.

Show all 9Show fewer

History of confirmed influenza infection within the last 12 Months.
Acute disease at the time of enrolment/vaccination.
History of allergy or reactions likely to be exacerbated by any component of the vaccine

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Conditions: Influenza
Being tested: GSK1247446A Group, Fluarix™
Keywords: Influenza vaccine, Prophylaxis Influenza vaccine
Medical subject headings: Influenza, Human

What participants receive

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

GSK1247446A GroupBiological
Also called Low dose adjuvanted influenza vaccine
Low dose influenza vaccine adjuvanted with AS03 compared
Fluarix™Biological
GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.

Study groups in NCT00363077
Study group	Role	What they receive
GSK1247446A Group	Experimental	Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: GSK1247446A Group
Fluarix Group	Active comparator	Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Receives: Biological: Fluarix™

What is being measured

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

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Measured: At Days 0 and 21
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Measured: At Day 21
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Measured: At Day 0 and Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Measured: At Day 21

Secondary outcomes (6)

Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
Measured: At Days 0 and 21
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
Measured: At Days 0 and 21
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With 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. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.
Measured: During the 30-day (Days 0-29) post vaccination period
Number of Subjects With Any and Related 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. Related = SAE considered by the investigator to have a causal relationship to study vaccination.
Measured: During the entire study period (from Day 0 to Day 29)

Timeline

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

2 Oct 200617 Nov 2006

First posted15 Aug 2006 (estimated)
Study start2 Oct 2006
Primary completion1 Nov 2006
Study completion17 Nov 2006

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00363077
Sponsor's protocol ID: 107975
Status last verified: Oct 2016
First submitted: 7 Aug 2006
Last updated: 8 Jun 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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.
ClinicalTrials.gov ID: NCT00363077
Acronym / sponsor ID: 107975
Conditions: Influenza
Keywords: Influenza vaccine, Prophylaxis Influenza vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 Oct 2006
Primary completion: 1 Nov 2006 (actual)
Study completion: 17 Nov 2006 (actual)
First posted: 15 Aug 2006 (estimated)
Results: Posted 7 May 2013

Clinical summary

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

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
GSK1247446A Group	Experimental	Biological: GSK1247446A GroupSubjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Fluarix Group	Active comparator	Biological: Fluarix™Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
A male or female 60 years or older at the time of the first vaccination.
Free of obvious health problems

Key exclusion criteria (9 listed)

Use of non-registered products
Administration of immune-modifying drugs.
Administration of vaccine 30 days before enrolment in study.
Immunosuppressive or immunodeficient condition.
Hypersensitivity to a previous dose of influenza vaccine

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
GSK1247446A GroupAlso: Low dose adjuvanted influenza vaccineLow dose influenza vaccine adjuvanted with AS03 compared	Biological	GSK1247446A Group
Fluarix™GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.	Biological	Fluarix Group

Primary outcome

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Time frame: At Days 0 and 21
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Time frame: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Time frame: At Day 0 and Day 21
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Time frame: At Day 21
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

6 secondary outcomes

Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Time frame: At Days 0 and 21
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Time frame: At Days 0 and 21
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time frame: During the 30-day (Days 0-29) post vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Time frame: During the entire study period (from Day 0 to Day 29)

Results and safety

Results posted to the registry on 7 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK1247446A Group	75	75
Fluarix Group	75	75

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

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

Measure	GSK1247446A Group n = 74	Fluarix Group n = 74
A/New Caledonia, Day 0	45.3 (35.9 to 57.1)	81.1 (61.5 to 106.8)
A/New Caledonia, Day 21	116.4 (91.2 to 148.5)	170.9 (132.7 to 220.3)
A/Wisconsin, Day 0	28.8 (20.7 to 40.1)	41.3 (29.1 to 58.6)
A/Wisconsin, Day 21	251.9 (188.7 to 336.4)	228.4 (168.5 to 309.6)
B/Malaysia, Day 0	27.1 (21.8 to 33.6)	31.6 (25.1 to 39.8)
B/Malaysia, Day 21	161.6 (131.4 to 198.6)	131.4 (105.8 to 163.1)

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.

Primary outcome: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

Time frame: At Day 21. Number. Unit: subjects

Measure	GSK1247446A Group n = 74	Fluarix Group n = 74
A/New Caledonia	21	12
A/Wisconsin	52	40
B/Malaysia	46	31

Primary outcome: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

Time frame: At Day 0 and Day 21. Number. Unit: subjects

Measure	GSK1247446A Group n = 74	Fluarix Group n = 74
A/New Caledonia, Day 0	40	54
A/New Caledonia, Day 21	68	73
A/Wisconsin, Day 0	35	44
A/Wisconsin, Day 21	69	71
B/Malaysia, Day 0	28	39
B/Malaysia, Day 21	72	70

Primary outcome: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

Time frame: At Day 21. Geometric mean (95% Confidence Interval). Unit: fold increase

Measure	GSK1247446A Group n = 74	Fluarix Group n = 74
A/New Caledonia	2.6 (2.0 to 3.3)	2.1 (1.6 to 2.8)
A/Wisconsin	8.7 (6.3 to 12.1)	5.5 (4.0 to 7.6)
B/Malaysia	6.0 (4.6 to 7.8)	4.2 (3.2 to 5.4)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1247446A Group	0 of 75 (0%)	69 of 75 (92%)	Not reported
Fluarix Group	1 of 75 (1.3%)	45 of 75 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK1247446A Group and Fluarix™ in people with Influenza, run by GlaxoSmithKline at 1 site in Belgium.

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 3 inclusion and 9 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 May 2013). 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?

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. (time frame: At Days 0 and 21). The study lists 4 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 NCT00363077.

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 8 Jun 2018.