Influenza, HumanPhase 3NCT00929331

Immunogenicity & Safety Study of Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years

A Phase 3 study testing Fluviral® in people with Influenza, Human, run by GlaxoSmithKline at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: Fluviral®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteCanada
Study dates: 11 Jul 2009to 1 Aug 2009
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 years and older
All sexes
Healthy volunteers accepted
Adult, 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.
Written informed consent obtained from the subject
Male and female adults, 18 to 60 years of age and over 60 years of age.
Satisfactory baseline medical assessment by history and physical examination
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Female subjects of non-childbearing potential may be enrolled in the study.

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Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
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

Participation in previous year's (2008) Fluviral® registration study
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <38.0°C.
Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:
Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.
Any confirmed or suspected immunosuppressive condition including: History of human immunodeficiency virus (HIV) infection, Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.

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History of renal impairment.
History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
Complicated insulin-dependent diabetes mellitus.
Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
Receipt of systemic glucocorticoids within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
Presence of an active neurological disorder.
History of chronic alcohol consumption and/or drug abuse.
Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
Receipt of an influenza vaccine within 6 months prior to study enrollment.
Administration of any vaccines within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
Any known or suspected allergy to any constituent of Fluviral® and/or a history of anaphylactic type reaction to constituent of the vaccine.
A history of severe adverse reaction to a previous influenza vaccination.
Lactating/nursing female.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1

Other trials in Canada

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years.

This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years.

Conditions: Influenza, Human
Being tested: Fluviral®
Keywords: Influenza, Fluviral®
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluviral®Biological
Intramuscular injection, one dose

Study groups in NCT00929331
Study group	Role	What they receive
Fluviral Adult Group	Experimental	Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm Receives: Biological: Fluviral®
Fluviral Elderly Group	Experimental	Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm Receives: Biological: Fluviral®

What is being measured

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

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Measured: At Day 0
GMTs of HI Antibodies
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Measured: At Day 21 after vaccination
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Measured: At Day 0
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Measured: At Day 21 after vaccination
Number of Seroconverted Subjects
A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Measured: At Day 21 after vaccination
Seroconversion Factors
Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Measured: At Day 21 after vaccination
Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value
The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Measured: At Day 21 after vaccination

Secondary outcomes (7)

Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Any = Solicited local symptoms are presented regardless of their intensity grade
Measured: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the site of injection. Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm
Measured: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Any Solicited General Symptoms
Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination. For temperature this means equal to or above 38.0 degrees celsius.
Measured: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius
Measured: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Related Solicited General Symptoms
Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius. Related = general symptom assessed by the investigator as related to the vaccine
Measured: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting 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 = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.
Measured: During a 21-day (Day 0-20) follow-up period after vaccination
Number of Subjects With Serious Adverse Events
SAEs assessed include medical occurrences that result in death, is 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: From the beginning up to the end of the study (Day 0 - Day 21)

Timeline

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

11 Jul 20091 Aug 2009

First posted29 Jun 2009 (estimated)
Study start11 Jul 2009
Primary completion1 Aug 2009
Study completion1 Aug 2009

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 Influenza, HumanStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929331
Sponsor's protocol ID: 110586
Status last verified: Oct 2020
First submitted: 25 Jun 2009
Last updated: 9 Nov 2020
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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral® (2009 - 2010 Season) in Adults Aged 18 to 60 Years and Over 60 Years.
ClinicalTrials.gov ID: NCT00929331
Acronym / sponsor ID: 110586
Conditions: Influenza, Human
Keywords: Influenza, Fluviral®
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 11 Jul 2009 (actual)
Primary completion: 1 Aug 2009 (actual)
Study completion: 1 Aug 2009 (actual)
First posted: 29 Jun 2009 (estimated)
Results: Posted 13 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to test the safety and immunogenicity of Fluviral® (2009 - 2010 Season) in adults aged 18 to 60 years and over 60 years.

Study design

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

Arm	Type	Receives
Fluviral Adult Group	Experimental	Biological: Fluviral®Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
Fluviral Elderly Group	Experimental	Biological: Fluviral®Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject
Male and female adults, 18 to 60 years of age and over 60 years of age.
Satisfactory baseline medical assessment by history and physical examination
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Key exclusion criteria (23 listed)

Participation in previous year's (2008) Fluviral® registration study
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <38.0°C.
Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:
Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.

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
Fluviral®Intramuscular injection, one dose	Biological	Fluviral Adult Group, Fluviral Elderly Group

Primary outcome

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies
Time frame: At Day 0
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
GMTs of HI Antibodies
Time frame: At Day 21 after vaccination
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
Time frame: At Day 0
The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value
Time frame: At Day 21 after vaccination
The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Number of Seroconverted Subjects
Time frame: At Day 21 after vaccination
A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Seroconversion Factors
Time frame: At Day 21 after vaccination
Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value
Time frame: At Day 21 after vaccination
The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.

7 secondary outcomes

Number of Subjects Reporting Any Solicited Local Symptoms
Time frame: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Time frame: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Any Solicited General Symptoms
Time frame: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Time frame: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Related Solicited General Symptoms
Time frame: During a 4-day (Day 0-3) follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: During a 21-day (Day 0-20) follow-up period after vaccination
Number of Subjects With Serious Adverse Events
Time frame: From the beginning up to the end of the study (Day 0 - Day 21)

Results and safety

Results posted to the registry on 13 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluviral Adult Group	55	55
Fluviral Elderly Group	55	55

Primary outcome: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies

Time frame: At Day 0. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Fluviral Adult Group n = 55	Fluviral Elderly Group n = 55
A/Brisbane	27.2 (18.8 to 39.5)	22.8 (16.8 to 31.1)
A/Uruguay	33.3 (21.8 to 50.7)	45.9 (31.3 to 67.3)
B/Brisbane	36.8 (26.5 to 51.1)	48.3 (34.4 to 67.7)

Population analysed: Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.

Primary outcome: GMTs of HI Antibodies

Time frame: At Day 21 after vaccination. Geometric mean (95% Confidence Interval). Unit: titer

Measure	Fluviral Adult Group n = 55	Fluviral Elderly Group n = 55
A/Brisbane	139.2 (101.6 to 190.6)	40.2 (29.7 to 54.5)
A/Uruguay	273.3 (192.8 to 387.3)	141.0 (100.0 to 198.8)
B/Brisbane	230.6 (177.4 to 299.7)	131.5 (95.2 to 181.7)

Primary outcome: Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value

Time frame: At Day 0. Number. Unit: subjects

Measure	Fluviral Adult Group n = 55	Fluviral Elderly Group n = 55
A/Brisbane	27	18
A/Uruguay	23	32
B/Brisbane	31	38

Primary outcome: Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value

Time frame: At Day 21 after vaccination. Number. Unit: subjects

Measure	Fluviral Adult Group n = 55	Fluviral Elderly Group n = 55
A/Brisbane	51	27
A/Uruguay	54	50
B/Brisbane	55	51

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events were collected during the 21-day (Day 0-20) post-vaccination period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluviral Adult Group	0 of 55 (0%)	34 of 55 (61.8%)	0 of 55
Fluviral Elderly Group	0 of 55 (0%)	16 of 55 (29.1%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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 3 study testing Fluviral® in people with Influenza, Human, run by GlaxoSmithKline at 1 site in Canada.

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 11 inclusion and 23 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 9 Nov 2020. 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 Canada. 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 13 Aug 2010). 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?

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies (time frame: At Day 0). The study lists 7 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 NCT00929331.

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 9 Nov 2020.