InfluenzaPhase 2NCT00374842

Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

A Phase 2 study testing Fluarix™ and GSK1247446A 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.

Trial summary

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluarix™ and GSK1247446A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteBelgium
Study dates: 3 Oct 2006to 30 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 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A male or female aged 18-59 years 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
Previous vaccination against influenza in 2006

Show all 10Show fewer

Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
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
Wilrijk, 2610

Other trials in Belgium

About this study

Official title: A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

Conditions: Influenza
Being tested: Fluarix™, GSK1247446A
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.

Fluarix™Biological
GlaxoSmithKline Biologicals' licensed influenza vaccine
GSK1247446ABiological
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine

Study groups in NCT00374842
Study group	Role	What they receive
GSK1247446A Formulation 1 Group	Experimental	Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK1247446A
GSK1247446A Formulation 2 Group	Experimental	Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: GSK1247446A
Fluarix Group	Active comparator	Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in 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 of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
Measured: At Day 0 and at Day 21.
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
Measured: At Day 0 and at Day 21.
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
Measured: At Day 21.
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).
Measured: At Day 21.

Secondary outcomes (4)

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
Measured: Within the 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
Measured: Within the 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: Within the 30-day follow-up period (Days 0-29) after vaccination
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. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Measured: From study start to study end, from Day 0 to Day 30

Timeline

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

3 Oct 200630 Nov 2006

First posted12 Sep 2006 (estimated)
Study start3 Oct 2006
Primary completion1 Nov 2006
Study completion30 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: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00374842
Sponsor's protocol ID: 108656
Status last verified: Oct 2016
First submitted: 8 Sep 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?

See locations

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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 Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.
ClinicalTrials.gov ID: NCT00374842
Acronym / sponsor ID: 108656
Conditions: Influenza
Keywords: Influenza vaccine, Prophylaxis Influenza vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Oct 2006
Primary completion: 1 Nov 2006 (actual)
Study completion: 30 Nov 2006 (actual)
First posted: 12 Sep 2006 (estimated)
Results: Posted 22 Apr 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 candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
GSK1247446A Formulation 1 Group	Experimental	Biological: GSK1247446ASubjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Formulation 2 Group	Experimental	Biological: GSK1247446ASubjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group	Active comparator	Biological: Fluarix™Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

A male or female aged 18-59 years at the time of the first vaccination.
Free of obvious health problems

Key exclusion criteria (10 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
Fluarix™GlaxoSmithKline Biologicals' licensed influenza vaccine	Biological	Fluarix Group
GSK1247446ALow-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine	Biological	GSK1247446A Formulation 1 Group, GSK1247446A Formulation 2 Group

Primary outcome

Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
Time frame: At Day 0 and at Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
Time frame: At Day 0 and at Day 21.
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
Time frame: At Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
Time frame: At Day 21.
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).

4 secondary outcomes

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within the 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within the 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within the 30-day follow-up period (Days 0-29) after vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Time frame: From study start to study end, from Day 0 to Day 30

Results and safety

Results posted to the registry on 22 Apr 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 Formulation 1 Group	100	100
GSK1247446A Formulation 2 Group	100	100
Fluarix Group	100	100

Primary outcome: Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.

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

Measure	GSK1247446A Formulation 1 Group n = 99	GSK1247446A Formulation 2 Group n = 99	Fluarix Group n = 98
A/CAL, Day 0	31.9 (23.5 to 43.4)	36.1 (26.9 to 48.5)	26.1 (20.5 to 33.2)
A/CAL, Day 21	475.4 (352.2 to 641.6)	399.0 (294.7 to 540.2)	380.6 (274.2 to 528.4)
A/WIS, Day 0	16.8 (13.1 to 21.5)	19.9 (15.2 to 25.9)	14.7 (11.6 to 18.6)
A/WIS, Day 21	276.2 (223.5 to 341.3)	241.9 (192.9 to 303.4)	172.3 (136.4 to 217.6)
B/MAL, Day 0	20.4 (15.9 to 26.1)	22.2 (17.6 to 27.9)	26.5 (20.9 to 33.6)
B/MAL, Day 21	268.6 (221.3 to 326.0)	301.5 (246.1 to 369.4)	219.2 (171.4 to 280.2)

Population analysed: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.

Primary outcome: Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.

Time frame: At Day 0 and at Day 21.. Number. Unit: Subject

Measure	GSK1247446A Formulation 1 Group n = 99	GSK1247446A Formulation 2 Group n = 99	Fluarix Group n = 98
A/CAL, Day 0	41	55	35
A/CAL, Day 21	95	97	93
A/WIS, Day 0	32	37	25
A/WIS, Day 21	97	97	93
B/MAL, Day 0	31	39	44
B/MAL, Day 21	97	98	94

Primary outcome: Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed

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

Measure	GSK1247446A Formulation 1 Group n = 99	GSK1247446A Formulation 2 Group n = 99	Fluarix Group n = 98
A/CAL, Day 21	69	64	66
A/WIS, Day 21	88	79	73
B/MAL, Day 21	76	82	65

Primary outcome: Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.

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

Measure	GSK1247446A Formulation 1 Group n = 99	GSK1247446A Formulation 2 Group n = 99	Fluarix Group n = 98
A/CAL, Day 21	14.9 (10.4 to 21.3)	11.0 (7.7 to 15.9)	14.6 (9.9 to 21.6)
A/WIS, Day 21	16.5 (13.0 to 20.9)	12.2 (9.2 to 16.1)	11.7 (8.8 to 15.6)
B/MAL, Day 21	13.2 (10.0 to 17.4)	13.6 (10.2 to 18.0)	8.3 (6.2 to 11.0)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1247446A Formulation 1 Group	1 of 100 (1%)	98 of 100 (98%)	Not reported
GSK1247446A Formulation 2 Group	0 of 100 (0%)	95 of 100 (95%)	Not reported
Fluarix Group	0 of 100 (0%)	81 of 100 (81%)	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 Fluarix™ and GSK1247446A 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 2 inclusion and 10 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 22 Apr 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 of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. (time frame: At Day 0 and at Day 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 NCT00374842.

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.