InfluenzaPhase 3NCT00992511
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes
A Phase 3 study testing GSK investigational vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 4 sites in Germany.
Trial summary
The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK investigational vaccine GSK2340272A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesGermany
- Study dates
- 14 Oct 2009to 9 Nov 2010
- Phase
- Phase 3
- 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
- All subjects must satisfy ALL the following criteria at study entry:
- A male or female aged 18 to 60 years of age at the time of the first vaccination.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Satisfactory baseline medical assessment by history and physical examination.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.
- Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 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 first dose of the study vaccine or planned use during the study period.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an axillary temperature >= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Show all 16Show fewer
- Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with coumarin derivatives, other vitamin K antagonists or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- Any contraindication to intramuscular administration of the influenza vaccines.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- Administration of any vaccines within 30 days before vaccination.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Freiberg, Saxony, 09599
GSK Investigational Site
Leipzig, Saxony, 04103
About this study
Official title: Immunological Non-inferiority Between Two Process-manufactured Influenza Vaccines in Adults Aged 18 to 60 Years
The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.
- Conditions
- Influenza
- Being tested
- GSK investigational vaccine GSK2340272A
- Keywords
- influenza infection, GSK Bio's influenza vaccine GSK2340272A
- 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 investigational vaccine GSK2340272ABiological
One intramuscular injection of initial process-manufactured GSK2340272A vaccine
GSK investigational vaccine GSK2340272ABiological
Two intramuscular injections of initial process-manufactured GSK2340272A vaccine
GSK investigational vaccine GSK2340272ABiological
One intramuscular injection of new process-manufactured GSK2340272A vaccine
GSK investigational vaccine GSK2340272ABiological
Two intramuscular injections of new process-manufactured GSK2340272A vaccine
| Study group | Role | What they receive |
|---|---|---|
| GSK2340272A New 1D Group | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. Receives: Biological: GSK investigational vaccine GSK2340272A |
| GSK2340272A New 2D Group | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: GSK investigational vaccine GSK2340272A |
| GSK2340272A INI 1D Group | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. Receives: Biological: GSK investigational vaccine GSK2340272A |
| GSK2340272A INI 2D Group | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. Receives: Biological: GSK investigational vaccine GSK2340272A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
Measured: At Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Day 21
Secondary outcomes (17)
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Measured: At Days 0 and 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Days 0 and 42
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
Measured: At Days 182 and 364
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Days 182 and 364
Number of Seroconverted (SCR) Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Measured: At Days 21 and 42
Number of SCR Subjects for HI Antibodies
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
Measured: At Days 182 and 364
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Measured: At Days 0, 21 and 42
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
Measured: At Days 182 and 364
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Days 21 and 42
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Days 182 and 364
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited Local Symptoms
The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and overall
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited General Symptoms
The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and overall
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Related pIMD was defined as an event assessed by the investigator as possibly related to the study vaccination.
Measured: During the entire study period (from Day 0 up to Day 364)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Day 0 up to Day 364)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study start14 Oct 2009
- Primary completion9 Nov 2010
- Study completion9 Nov 2010
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 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
- NCT00992511
- Sponsor's protocol ID
- 113809
- Status last verified
- May 2018
- First submitted
- 8 Oct 2009
- Last updated
- 31 Jan 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Non-inferiority Between Two Process-manufactured Influenza Vaccines in Adults Aged 18 to 60 Years
- ClinicalTrials.gov ID
- NCT00992511
- Acronym / sponsor ID
- 113809
- Conditions
- Influenza
- Keywords
- influenza infection, GSK Bio's influenza vaccine GSK2340272A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2009 (actual)
- Primary completion
- 9 Nov 2010 (actual)
- Study completion
- 9 Nov 2010 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GSK2340272A New 1D Group | Experimental | Biological: GSK investigational vaccine GSK2340272AHealthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. |
| GSK2340272A New 2D Group | Experimental | Biological: GSK investigational vaccine GSK2340272AHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
| GSK2340272A INI 1D Group | Experimental | Biological: GSK investigational vaccine GSK2340272AHealthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0. |
| GSK2340272A INI 2D Group | Experimental | Biological: GSK investigational vaccine GSK2340272AHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All subjects must satisfy ALL the following criteria at study entry:
- A male or female aged 18 to 60 years of age at the time of the first vaccination.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Satisfactory baseline medical assessment by history and physical examination.
Key exclusion criteria (16 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an axillary temperature >= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
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 investigational vaccine GSK2340272AOne intramuscular injection of initial process-manufactured GSK2340272A vaccine | Biological | GSK2340272A New 1D Group |
| GSK investigational vaccine GSK2340272ATwo intramuscular injections of initial process-manufactured GSK2340272A vaccine | Biological | GSK2340272A New 2D Group |
| GSK investigational vaccine GSK2340272AOne intramuscular injection of new process-manufactured GSK2340272A vaccine | Biological | GSK2340272A INI 1D Group |
| GSK investigational vaccine GSK2340272ATwo intramuscular injections of new process-manufactured GSK2340272A vaccine | Biological | GSK2340272A INI 2D Group |
Primary outcome
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Day 21
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Time frame: At Day 21
Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.
17 secondary outcomes
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Days 0 and 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Time frame: At Days 0 and 42
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Days 182 and 364
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
Time frame: At Days 182 and 364
Number of Seroconverted (SCR) Subjects for HI Antibodies
Time frame: At Days 21 and 42
Number of SCR Subjects for HI Antibodies
Time frame: At Days 182 and 364
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Days 0, 21 and 42
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Days 182 and 364
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Time frame: At Days 21 and 42
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
Time frame: At Days 182 and 364
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and overall
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Days With Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and overall
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Time frame: During the entire study period (from Day 0 up to Day 364)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Day 364)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK investigational vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 4 sites in Germany.
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 7 inclusion and 16 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 31 Jan 2019). 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 Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain (time frame: At Day 21). The study lists 2 primary outcomes in all. 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 31 Jan 2019.