Infections, MeningococcalPhase 2NCT00471081
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
A Phase 2 study testing Meningococcal vaccine GSK134612 in people with Infections, Meningococcal, run by GlaxoSmithKline at 19 sites in United States.
Trial summary
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age. Read more about this study
- Who is it for?
- Ages 9 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal vaccine GSK134612
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 19 sitesUnited States
- Study dates
- 5 Jul 2007to 26 Nov 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 9 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
- Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
- Written informed consent obtained from parents/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination 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 preceding enrollment, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
- Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
- Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
- History of meningococcal diseases.
Show all 13Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrollment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
GSK Investigational Site
Amarillo, Texas, 79124
GSK Investigational Site
Antioch, California, 94509
GSK Investigational Site
Benton, Arkansas, 72015
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Birmingham, Georgia, 35244
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Erie, Pennsylvania, 16501
GSK Investigational Site
Fremont, California, 94538
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Hayward, California, 94545
GSK Investigational Site
Lakewood, Colorado, 80226
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Littleton, Colorado, 80122
GSK Investigational Site
Littleton, Colorado, 80234
GSK Investigational Site
Madera, California, 93637
GSK Investigational Site
Santa Rosa, California, 95403
GSK Investigational Site
Vacaville, California, 95688
GSK Investigational Site
Westminster, Colorado, 80234
GSK Investigational Site
Wheat Ridge, Colorado, 80033
About this study
Official title: Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
Read the detailed description
The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion \& Exclusion criteria.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal vaccine GSK134612
- Keywords
- Neisseria meningitidis;, Humans;, Meningococcal vaccines;, Safety, Vaccines, conjugate;, Toddlers;, Immunogenicity;
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccine GSK134612Biological
One or 2 intramuscular injections.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Single dose GSK134612. Receives: Biological: Meningococcal vaccine GSK134612 |
| Group B | Experimental | Two doses of GSK134612. Receives: Biological: Meningococcal vaccine GSK134612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Measured: One month after the last dose (at Month 4)
Secondary outcomes (16)
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Measured: One month after the first dose (at Month 1)
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Measured: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
Measured: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
Measured: At Month 1 (GSK 134612 2 doses Group only) and Month 4
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Measured: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
Measured: At Month 1 (GSK 134612 s doses Group only) and Month 4
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Measured: At Month 1 (GSK 134612 2 doses Group only) and Month 4
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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of Subjects With Any 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.
Measured: Up to 1 month post-vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Up to study end (Month 9)
Number of Subjects With New Onset Chronic Ilnesses (NOCI)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: Up to study end (Month 9)
Number of Subjects Reporting Rash
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Measured: Up to study end (Month 9)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Measured: Up to study end (Month 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study start5 Jul 2007
- Primary completion23 Oct 2008
- Study completion26 Nov 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infections, MeningococcalStudies 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
- None (open label)
- Enrolment
- 385 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
- NCT00471081
- Sponsor's protocol ID
- 109375
- Status last verified
- Jun 2019
- First submitted
- 8 May 2007
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Klein NP, Baine Y, Bianco V, Lestrate PR, Naz A, Blatter M, Friedland LR, Miller JM. One or two doses of quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine is immunogenic in 9- to 12-month-old children. Pediatr Infect Dis J. 2013 Jul;32(7):760-7. doi: 10.1097/INF.0b013e31828693c5.
PubMed 23348814Klein N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age
- ClinicalTrials.gov ID
- NCT00471081
- Acronym / sponsor ID
- 109375
- Conditions
- Infections, Meningococcal
- Keywords
- Neisseria meningitidis;, Humans;, Meningococcal vaccines;, Safety, Vaccines, conjugate;, Toddlers;, Immunogenicity;
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2007 (actual)
- Primary completion
- 23 Oct 2008 (actual)
- Study completion
- 26 Nov 2008 (actual)
- First posted
- 9 May 2007 (estimated)
- Results
- Posted 14 Sep 2018
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 the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
Detailed description
The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion \& Exclusion criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Meningococcal vaccine GSK134612Single dose GSK134612. |
| Group B | Experimental | Biological: Meningococcal vaccine GSK134612Two doses of GSK134612. |
Who may qualify
- Ages
- 9 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
- Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
- Written informed consent obtained from parents/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (13 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
- Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
- Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
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 |
|---|---|---|
| Meningococcal vaccine GSK134612One or 2 intramuscular injections. | Biological | Group A, Group B |
Primary outcome
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
Time frame: One month after the last dose (at Month 4)
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
16 secondary outcomes
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
Time frame: One month after the first dose (at Month 1)
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
Time frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
Time frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
Time frame: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Time frame: At Month 1 (GSK 134612 s doses Group only) and Month 4
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Time frame: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Up to 1 month post-vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Up to study end (Month 9)
Number of Subjects With New Onset Chronic Ilnesses (NOCI)
Time frame: Up to study end (Month 9)
Number of Subjects Reporting Rash
Time frame: Up to study end (Month 9)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: Up to study end (Month 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23348814Klein NP, Baine Y, Bianco V, Lestrate PR, Naz A, Blatter M, Friedland LR, Miller JM. One or two doses of quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine is immunogenic in 9- to 12-month-old children. Pediatr Infect Dis J. 2013 Jul;32(7):760-7. doi: 10.1097/INF.0b013e31828693c5.
- BackgroundKlein N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
- 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. IPD for this study will be made available via the Clinical Study Data Request 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
19 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 Meningococcal vaccine GSK134612 in people with Infections, Meningococcal, run by GlaxoSmithKline at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value (time frame: One month after the last dose (at Month 4)). 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 NCT00471081, which also lists 2 linked publications.
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 25 Jun 2019.