InfluenzaPhase 2NCT00633074
Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
A Phase 2 study testing Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) and Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A) in people with Influenza, run by GlaxoSmithKline at 3 sites in Estonia.
Trial summary
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine. 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?
- Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) and Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 3 sitesEstonia
- Study dates
- 3 Mar 2008to 11 Apr 2008
- 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 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.
- A male or female 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 (medical history and medical history directed examination) before entering into the study.
Who cannot join
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Any medical conditions in which IM injections are contraindicated
Trial locations and contacts
3 sites in 1 country.
Estonia3 sites
GSK Investigational Site
Saku, 75501
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tartu, 50417
About this study
Official title: Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
- Conditions
- Influenza
- Being tested
- Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A), Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)Biological
Intramuscular administration, 1 dose
Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)Biological
Intramuscular administration, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Thiomersal-free FluAS25 adjuvanted vaccine group | Experimental | Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine Receives: Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) |
| Thiomersal reduced FluAS25 adjuvanted vaccine group | Experimental | Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine Receives: Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: Days 0 and 21
Secondary outcomes (11)
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against the Three 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 three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: Day 21
HI Antibody Seroconversion Factors
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Measured: Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Measured: Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Measured: During a 7-day period after vaccination
Duration of Solicited Local Symptoms
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Measured: During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Measured: During a 7-day period after vaccination
Duration of Solicited General Symptoms
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Measured: During a 7-day period after vaccination
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 a 21-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
Measured: During a 21-day period after vaccination
Number of Subjects Reporting 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.
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.
- First posted11 Mar 2008 (estimated)
- Study start3 Mar 2008
- Primary completion11 Apr 2008
- Study completion11 Apr 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633074
- Sponsor's protocol ID
- 111454
- Status last verified
- Nov 2016
- First submitted
- 29 Feb 2008
- 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.
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
- Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
- ClinicalTrials.gov ID
- NCT00633074
- Acronym / sponsor ID
- 111454
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2008
- Primary completion
- 11 Apr 2008 (actual)
- Study completion
- 11 Apr 2008 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 28 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 purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiomersal-free FluAS25 adjuvanted vaccine group | Experimental | Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine |
| Thiomersal reduced FluAS25 adjuvanted vaccine group | Experimental | Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine |
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.
- A male or female 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 (medical history and medical history directed examination) before entering into the study.
Key exclusion criteria (13 listed)
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
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 |
|---|---|---|
| Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)Intramuscular administration, 1 dose | Biological | Thiomersal-free FluAS25 adjuvanted vaccine group |
| Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)Intramuscular administration, 1 dose | Biological | Thiomersal reduced FluAS25 adjuvanted vaccine group |
Primary outcome
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Time frame: Days 0 and 21
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
11 secondary outcomes
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Time frame: Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Time frame: Day 21
HI Antibody Seroconversion Factors
Time frame: Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
Time frame: Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During a 7-day period after vaccination
Duration of Solicited Local Symptoms
Time frame: During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During a 7-day period after vaccination
Duration of Solicited General Symptoms
Time frame: During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During a 21-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Time frame: During a 21-day period after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (up to Day 21)
Results and safety
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A) and Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A) in people with Influenza, run by GlaxoSmithKline at 3 sites in Estonia.
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 13 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 3 sites in 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 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 28 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 Titer Against the Three Vaccine Strains (time frame: Days 0 and 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.