InfluenzaPhase 2NCT00532298
Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
A Phase 2 study testing GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season], GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] and Fluarix [NH 2006/07 season] in people with Influenza, run by GlaxoSmithKline at 6 sites in 3 countries.
Trial summary
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season], GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] and Fluarix [NH 2006/07 season]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,596 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 20 Sep 2007to 2 Nov 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 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 aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Show all 12Show fewer
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation 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 administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular injections are contraindicated.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Norway4 sites
GSK Investigational Site
Bergen, 5094
GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Hamar, 2317
GSK Investigational Site
Stavanger, 4010
About this study
Official title: Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
- Conditions
- Influenza
- Being tested
- GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season], GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season], Fluarix [NH 2006/07 season], Fluarix [NH 2007/08 season]
- Keywords
- Fluarix, Influenza Infection, GSK Biologicals' influenza vaccine GSK576389A
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]Biological
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]Biological
Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Fluarix [NH 2006/07 season]Biological
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
Fluarix [NH 2007/08 season]Biological
Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
| Study group | Role | What they receive |
|---|---|---|
| GSK576389A- 2006/2007 Season - 1 container Group | Experimental | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container. Receives: Biological: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] |
| GSK576389A - 2006/2007 Season - 2 containers Group | Experimental | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers. Receives: Biological: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] |
| Fluarix 2006/2007 Season Group | Active comparator | Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. Receives: Biological: Fluarix [NH 2006/07 season] |
| GSK576389A - 2007/2008 Season - 1 container Group | Experimental | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container. Receives: Biological: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] |
| GSK576389A - 2007/2008 Season - 2 containers Group | Experimental | Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers. Receives: Biological: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] |
| Fluarix 2007/2008 Season Group | Active comparator | Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. Receives: Biological: Fluarix [NH 2007/08 season] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
Measured: At Days 0 and 21
Secondary outcomes (11)
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
Measured: At Days 0 and 21
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
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 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Measured: At Day 21
HI Antibody Seroconversion Factors
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Measured: At Day 21
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
Measured: At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited General AEs
Duration was defined as number of days with any grade of general symptoms.
Measured: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Measured: During a 21-day follow-up period (Day 0-20) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
Measured: During a 21-day follow-up period (Day 0-20) 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: During a 21-day follow-up period (Day 0-20) after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study start20 Sep 2007
- Primary completion1 Nov 2007
- Study completion2 Nov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,596 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
- NCT00532298
- Sponsor's protocol ID
- 110620
- Status last verified
- Nov 2016
- First submitted
- 19 Sep 2007
- 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 of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
- ClinicalTrials.gov ID
- NCT00532298
- Acronym / sponsor ID
- 110620
- Conditions
- Influenza
- Keywords
- Fluarix, Influenza Infection, GSK Biologicals' influenza vaccine GSK576389A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,596 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2007
- Primary completion
- 1 Nov 2007 (actual)
- Study completion
- 2 Nov 2007 (actual)
- First posted
- 20 Sep 2007 (estimated)
- Results
- Posted 22 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GSK576389A- 2006/2007 Season - 1 container Group | Experimental | Biological: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container. |
| GSK576389A - 2006/2007 Season - 2 containers Group | Experimental | Biological: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers. |
| Fluarix 2006/2007 Season Group | Active comparator | Biological: Fluarix [NH 2006/07 season]Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. |
| GSK576389A - 2007/2008 Season - 1 container Group | Experimental | Biological: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container. |
| GSK576389A - 2007/2008 Season - 2 containers Group | Experimental | Biological: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers. |
| Fluarix 2007/2008 Season Group | Active comparator | Biological: Fluarix [NH 2007/08 season]Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. |
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 aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study 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 |
|---|---|---|
| GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season]Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season. | Biological | GSK576389A - 2006/2007 Season - 2 containers Group, GSK576389A- 2006/2007 Season - 1 container Group |
| GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season]Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season. | Biological | GSK576389A - 2007/2008 Season - 1 container Group, GSK576389A - 2007/2008 Season - 2 containers Group |
| Fluarix [NH 2006/07 season]Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season. | Biological | Fluarix 2006/2007 Season Group |
| Fluarix [NH 2007/08 season]Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season. | Biological | Fluarix 2007/2008 Season Group |
Primary outcome
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
Time frame: At Days 0 and 21
Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
11 secondary outcomes
HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
Time frame: At Days 0 and 21
The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Time frame: At Day 21
HI Antibody Seroconversion Factors
Time frame: At Day 21
The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Time frame: At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited Local AEs
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Duration of Solicited General AEs
Time frame: During a 7-day follow-up period (Day 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Time frame: During a 21-day follow-up period (Day 0-20) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Time frame: During a 21-day follow-up period (Day 0-20) after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: During a 21-day follow-up period (Day 0-20) after vaccination
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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season], GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] and Fluarix [NH 2006/07 season] in people with Influenza, run by GlaxoSmithKline at 6 sites in 3 countries.
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 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 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 6 sites in Norway, Denmark, 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 22 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?
Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain (time frame: At Days 0 and 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 8 Nov 2026.