InfluenzaPhase 2NCT00545025

Revaccination With Influenza Vaccine GSK1247446A

A Phase 2 study testing Influenza Vaccine GSK1247446A and Fluarix™ in people with Influenza and Influenza, Human, 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

Search all trials

Trial summary

The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Influenza, Human
What is being tested?: Influenza Vaccine GSK1247446A and Fluarix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 243 participants
Where: 1 siteBelgium
Study dates: 15 Oct 2007to 12 Dec 2007
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
Free of obvious health problems 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 of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period
Previous vaccination against influenza since January 2007.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

Show all 12Show fewer

Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
History of hypersensitivity to a previous dose of influenza vaccine.
History of confirmed influenza infection within the last 12 months.
Pregnancy.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
Acute disease at the time of enrolment.

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: Safety and Immunogenicity of a Second Vaccination With GSK Biologicals' Influenza Vaccine GSK1247446A in Subjects 18-60 Years Previously Vaccinated in Study 108656

The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.

Read the detailed description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions: Influenza, Influenza, Human
Being tested: Influenza Vaccine GSK1247446A, Fluarix™
Keywords: Influenza, 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.

Influenza Vaccine GSK1247446ABiological
Single dose, Intramuscular injection
Fluarix™Biological
Single dose, Intramuscular injection

Study groups in NCT00545025
Study group	Role	What they receive
GSK1247446A Group	Experimental	Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862. Receives: Biological: Influenza Vaccine GSK1247446A
Fluarix Group	Active comparator	Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltiod region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. Receives: Biological: Fluarix™

What is being measured

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

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 everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.
Measured: During a 7-day (Days 0-6) follow-up period after re-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)], headache, myalgia, nausea 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 a 7-day (Days 0-6) follow-up after re-vaccination
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 normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Measured: During a 30-day (Days 0-29) follow-up period after re-vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Serious adverse events (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 assessed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (Days 0-30)

Secondary outcomes (4)

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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Measured: At Day 0 and 21
Seroconversion Factor for 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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Measured: At Day 21

Timeline

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

15 Oct 200712 Dec 2007

First posted16 Oct 2007 (estimated)
Study start15 Oct 2007
Primary completion12 Dec 2007
Study completion12 Dec 2007

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00545025
Sponsor's protocol ID: 110674
Other IDs: 2007-002783-10
Status last verified: Jun 2019
First submitted: 15 Oct 2007
Last updated: 26 Jun 2019
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 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of a Second Vaccination With GSK Biologicals' Influenza Vaccine GSK1247446A in Subjects 18-60 Years Previously Vaccinated in Study 108656
ClinicalTrials.gov ID: NCT00545025
Acronym / sponsor ID: 110674
Conditions: Influenza, Influenza, Human
Keywords: Influenza, Influenza vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Oct 2007 (actual)
Primary completion: 12 Dec 2007 (actual)
Study completion: 12 Dec 2007 (actual)
First posted: 16 Oct 2007 (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 protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.

Detailed description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study design

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

Arm	Type	Receives
GSK1247446A Group	Experimental	Biological: Influenza Vaccine GSK1247446ASubjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
Fluarix Group	Active comparator	Biological: Fluarix™Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltiod region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject.
Free of obvious health problems 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 of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Key exclusion criteria (12 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period
Previous vaccination against influenza since January 2007.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.

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
Influenza Vaccine GSK1247446ASingle dose, Intramuscular injection	Biological	GSK1247446A Group
Fluarix™Single dose, Intramuscular injection	Biological	Fluarix Group

Primary outcome

Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Time frame: During a 7-day (Days 0-6) follow-up period after re-vaccination
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 everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During a 7-day (Days 0-6) follow-up after re-vaccination
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)], headache, myalgia, nausea 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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During a 30-day (Days 0-29) follow-up period after re-vaccination
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 normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (Days 0-30)
Serious adverse events (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 assessed by the investigator as causally related to the study vaccination.

4 secondary outcomes

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Time frame: At Days 0 and 21
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Time frame: At Day 21
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Time frame: At Day 0 and 21
Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.
Time frame: At Day 21

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	160	160
Fluarix Group	83	83

Primary outcome: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

Time frame: During a 7-day (Days 0-6) follow-up period after re-vaccination. Number. Unit: Subjects

Measure	GSK1247446A Group n = 160	Fluarix Group n = 83
Any Ecchymosis	8	5
Ecchymosis > 50mm	1	2
Any Pain	143	57
Grade 3 Pain	9	2
Any Redness	24	10
Redness > 50mm	2	1
Any Swelling	29	13
Swelling > 50mm	4	2

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Primary outcome: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

Time frame: During a 7-day (Days 0-6) follow-up after re-vaccination. Number. Unit: Subjects

Measure	GSK1247446A Group n = 160	Fluarix Group n = 83
Any Arthralgia	28	5
Grade 3 Arthralgia	3	0
Related Arthralgia	26	5
Any Fatigue	72	12
Grade 3 Fatigue	7	2
Related Fatigue	71	10
Fever ≥37.5°C	27	2
Fever >39.0°C	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Primary outcome: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Time frame: During a 30-day (Days 0-29) follow-up period after re-vaccination. Number. Unit: Subjects

Measure	GSK1247446A Group n = 160	Fluarix Group n = 83
Any AEs	69	31
Grade 3 AEs	16	10
Related AEs	35	8

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Primary outcome: Number of Subjects With Any and Related Serious Adverse Events (SAEs)

Time frame: During the entire study period (Days 0-30). Number. Unit: Subjects

Measure	GSK1247446A Group n = 160	Fluarix Group n = 83
Any SAEs	0	1
Related SAEs	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1247446A Group	0 of 160 (0%)	143 of 160 (89.4%)	0 of 160
Fluarix Group	1 of 83 (1.2%)	57 of 83 (68.7%)	0 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
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 Influenza Vaccine GSK1247446A and Fluarix™ in people with Influenza and Influenza, Human, 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 5 inclusion and 12 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 26 Jun 2019. 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?

Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms (time frame: During a 7-day (Days 0-6) follow-up period after re-vaccination). 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 NCT00545025.

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 26 Jun 2019.