Infections, MeningococcalPhase 3NCT00464815

Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

A Phase 3 study testing Meningococcal vaccine GSK134612 and Mencevax™ ACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 7 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. Read more about this study

Who is it for?: Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: Meningococcal vaccine GSK134612 and Mencevax™ ACWY
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,025 participants
Where: 7 sitesin 3 countries
Study dates: 2 May 2007to 10 Sep 2008
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 11 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
Previous vaccination with tetanus toxoid within the last month.

Show all 16Show fewer

History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
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(s).
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

India4 sites

GSK Investigational Site
Goa, 403202
GSK Investigational Site
Indore, 452001
GSK Investigational Site
New Delhi, 110002
GSK Investigational Site
Pune, 411 011

Other trials in India

Taiwan2 sites

GSK Investigational Site
Taipei, 100
GSK Investigational Site
Tao Yuan County, 333

Other trials in Taiwan

Philippines1 site

GSK Investigational Site
City of Muntinlupa, 1781

Other trials in Philippines

About this study

Official title: Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Read the detailed description

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions: Infections, Meningococcal
Being tested: Meningococcal vaccine GSK134612, Mencevax™ ACWY
Keywords: immunogenicity, safety, meningococcal vaccine
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 intramuscular dose
Mencevax™ ACWYBiological
One subcutaneous dose

Study groups in NCT00464815
Study group	Role	What they receive
Group A	Experimental	Subjects of 11-17 years of age who will receive GSK134612 Receives: Biological: Meningococcal vaccine GSK134612
Group B	Active comparator	Subjects of 11-17 years of age who will receive MencevaxTM ACWY Receives: Biological: Mencevax™ ACWY

What is being measured

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

Number of Subjects With Vaccine Response to Meningococcal Antigens
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
Measured: One month post-vaccination (At Month 1)
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).
Measured: During the 4-day (Days 0-3) period after vaccination

Secondary outcomes (11)

Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: Prior to (Month 0) and one month after vaccination (Month 1)
Meningococcal rSBA Antibody Titers
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
Measured: Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).
Measured: Prior to (Month 0) and one month after vaccination (Month 1)
Anti-TT Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Measured: Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal Polysaccharide Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Measured: Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
Measured: During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any Unsolicited Adverse Events
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: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Any 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 6)
Number of Subjects With Specific Adverse Events
These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).
Measured: Up to study end (Month 6)

Timeline

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

2 May 200710 Sep 2008

First posted24 Apr 2007 (estimated)
Study start2 May 2007
Primary completion16 Apr 2008
Study completion10 Sep 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 (1)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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,025 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00464815
Sponsor's protocol ID: 109069
Status last verified: Mar 2018
First submitted: 23 Apr 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.

Publications

Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 1.
PubMed 21343698

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?

See locations

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All Infections, Meningococcal trials

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: Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY
ClinicalTrials.gov ID: NCT00464815
Acronym / sponsor ID: 109069
Conditions: Infections, Meningococcal
Keywords: immunogenicity, safety, meningococcal vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,025 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 May 2007 (actual)
Primary completion: 16 Apr 2008 (actual)
Study completion: 10 Sep 2008 (actual)
First posted: 24 Apr 2007 (estimated)
Results: Posted 2 Apr 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 this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Detailed description

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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 GSK134612Subjects of 11-17 years of age who will receive GSK134612
Group B	Active comparator	Biological: Mencevax™ ACWYSubjects of 11-17 years of age who will receive MencevaxTM ACWY

Who may qualify

Ages: 11 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.

Key exclusion criteria (16 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 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 intramuscular dose	Biological	Group A
Mencevax™ ACWYOne subcutaneous dose	Biological	Group B

Primary outcome

Number of Subjects With Vaccine Response to Meningococcal Antigens
Time frame: One month post-vaccination (At Month 1)
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
Time frame: During the 4-day (Days 0-3) period after vaccination
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).

11 secondary outcomes

Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Meningococcal rSBA Antibody Titers
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Anti-TT Antibody Concentrations
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal Polysaccharide Concentrations
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any Unsolicited Adverse Events
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: Up to study end (Month 6)
Number of Subjects With Specific Adverse Events
Time frame: Up to study end (Month 6)

Results and safety

Results posted to the registry on 2 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nimenrix Group	768	762
Mencevax ACWY Group	257	254

Primary outcome: Number of Subjects With Vaccine Response to Meningococcal Antigens

Time frame: One month post-vaccination (At Month 1). Count of participants. Unit: Participants

Measure	Nimenrix Group n = 657	Mencevax ACWY Group n = 219
rSBA-MenA	472	148
rSBA-MenC	625	204
rSBA-MenW-135	616	189
rSBA-MenY	616	172

Nimenrix Group vs Mencevax ACWY Group: Rate difference: 7.87 (95% CI 1.63 to 14.87)
Nimenrix Group vs Mencevax ACWY Group: Rate Difference: 0.67 (95% CI -1.65 to 4.18)
Nimenrix Group vs Mencevax ACWY Group: Rate difference: 8.9 (95% CI 4.78 to 14.14)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.

Primary outcome: Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms

Time frame: During the 4-day (Days 0-3) period after vaccination. Count of participants. Unit: Participants

Measure	Nimenrix Group n = 768	Mencevax ACWY Group n = 257
Value	12	1

Nimenrix Group vs Mencevax ACWY Group: Risk Ratio (RR): 4.02 (95% CI 0.68 to 24.6), p = 0.1456, Chi-squared

Population analysed: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general adverse events (AEs): during the 4-day (Days 0-3) period after vaccination. Unsolicited AEs: up to one month after vaccination (Month 1). SAEs and specific AEs: up to study end (Month 6).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimenrix Group	3 of 768 (0.4%)	311 of 768 (40.5%)	0 of 768
Mencevax ACWY Group	2 of 257 (0.8%)	99 of 257 (38.5%)	0 of 257

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.
Derived from this study: PubMed 21343698Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 1.
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.

Related trials for Infections, Meningococcal

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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Active, not recruitingPhase 2
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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

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal vaccine GSK134612 and Mencevax™ ACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 7 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 6 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 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 7 sites in India, Taiwan, Philippines. 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 2 Apr 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 Vaccine Response to Meningococcal Antigens (time frame: One month post-vaccination (At Month 1)). 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?

On the ClinicalTrials.gov record for NCT00464815, which also lists 1 linked publication.

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.