DenguePhase 1NCT01477580
Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
A Phase 1 study testing Low-dose V180 with low-dose ISCOMATRIX™ adjuvant, Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant and Medium-dose V180 (non-adjuvanted) in people with Dengue, run by Merck Sharp & Dohme LLC.
Trial summary
This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Low-dose V180 with low-dose ISCOMATRIX™ adjuvant, Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant and Medium-dose V180 (non-adjuvanted)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 23 Jul 2012to 11 Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Selected Inclusion Criteria:
- In good health
- Voluntarily agrees to participate by giving written informed consent
- Able to read, understand, and complete study questionnaires
- Able to complete all scheduled visits and comply with study procedures
- Access to a telephone
- Agrees to avoid unusual, vigorous exercise from 72 hours before any dose of study vaccine/placebo through 15 days after that dose
- Weighs ≥110 pounds (50 kg) and has a body mass index (BMI) of 19 to 32 kg/m^2
- No fever (temperature ≥100.4°F/38.0°C) for 72 hours prior to vaccination
- Females of reproductive potential agree to remain abstinent or to use 2 acceptable methods of birth control from enrollment through 6 weeks after the last dose of study vaccine/placebo
Selected Exclusion Criteria:
- History of receiving any flavivirus vaccine (e.g. Japanese encephalitis, tick-borne encephalitis, or yellow fever) or planned receipt of any such vaccine during the study period
- History of any flavivirus infection or serologic evidence of any flavivirus infection, including West Nile, dengue, yellow fever, Saint Louis encephalitis (if available), Kunjin, Murray Valley encephalitis, and Japanese encephalitis
- History of residence for a cumulative period of >1 year in a country where dengue, Japanese encephalitis virus, or yellow fever virus is common
- Planned travel to an area where dengue is common through 28 days after receiving the last dose of study vaccine/placebo
- Known hypersensitivity to any component of the dengue vaccine
- Abuse of drugs or alcohol within 12 months prior to screening
- Pregnant or breastfeeding, or expecting to conceive in the time from enrollment through 6 weeks after the last dose of study vaccine/placebo
- Positive serum test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and/or hepatitis C antibody
- Known, suspected, or a history of immunocompromise
- History of malignancy within 5 years prior to enrollment
- Poorly controlled diabetes mellitus
- Use of any immunosuppressive therapy (except topical and inhaled/nebulized steroids)
- Receipt of any licensed non-live vaccine within 14 days prior to the first dose of study vaccine/placebo or plans to receive a licensed non-live vaccine during the time between receiving the first dose and 28 days after receiving the last dose of study vaccine/placebo
- Receipt of any licensed live vaccine within 30 days prior to the first dose of study vaccine/placebo or plans to receive a licensed live vaccine during the time between receiving the first dose and 28 after receiving the last dose of study vaccine/placebo
- Received investigational drugs or vaccines within 2 months prior to the first dose of study vaccine/placebo
- History of receiving 1 or more doses of an investigational dengue vaccine
- Participation in another clinical study within 42 days prior to enrollment, or plans to participate in another clinical study from enrollment through 1 year after the last dose of study vaccine/placebo
- Planned donation of eggs or sperm from the time of enrollment through 28 days after the last dose of study vaccine/placebo
- Prior receipt of a blood transfusion or blood products within 6 months prior to the first dose of study vaccine/placebo
- Hospitalization for acute illness within 3 months prior to the first dose of vaccine/placebo
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults
This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.
- Conditions
- Dengue
- Being tested
- Low-dose V180 with low-dose ISCOMATRIX™ adjuvant, Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant, Medium-dose V180 (non-adjuvanted), Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant, Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose V180 with low-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Low-dose V180 with medium-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Medium-dose V180 (non-adjuvanted)Biological
Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
Medium-dose V180 with low-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Medium-dose V180 with Alhydrogel™ adjuvantBiological
Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
High-dose V180 (non-adjuvanted)Biological
Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
High-dose V180 with low-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
High-dose V180 with medium-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Low-dose V180 with high-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
Medium-dose V180 with high-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
High-dose V180 with high-dose ISCOMATRIX™ adjuvantBiological
Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
PlaceboBiological
Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
| Study group | Role | What they receive |
|---|---|---|
| Low-dose V180 with low-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Medium-dose Non-adjuvanted V180 | Experimental | Not described Receives: Biological: Medium-dose V180 (non-adjuvanted) |
| Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Medium-Dose V180 with Alhydrogel™ adjuvant | Experimental | Not described Receives: Biological: Medium-dose V180 with Alhydrogel™ adjuvant |
| High-dose Non-adjuvanted V180 | Experimental | Not described Receives: Biological: High-dose V180 (non-adjuvanted) |
| High-dose V180 with low-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: High-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| High-dose V180 with medium-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Low-dose V180 with high-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| High-dose V180 with high-dose ISCOMATRIX™ adjuvant | Experimental | Not described Receives: Biological: High-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate for each serotype
Measured: 28 days postdose 3 (Day 84)
Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype
Measured: 28 days postdose 3 (Day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study start23 Jul 2012
- Primary completion23 Jan 2014
- Study completion11 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477580
- Sponsor's protocol ID
- V180-001
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2011
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Manoff SB, Sausser M, Falk Russell A, Martin J, Radley D, Hyatt D, Roberts CC, Lickliter J, Krishnarajah J, Bett A, Dubey S, Finn T, Coller BA. Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naive adults. Hum Vaccin Immunother. 2019;15(9):2195-2204. doi: 10.1080/21645515.2018.1546523. Epub 2019 Jun 3.
PubMed 30427741Manoff SB, George SL, Bett AJ, Yelmene ML, Dhanasekaran G, Eggemeyer L, Sausser ML, Dubey SA, Casimiro DR, Clements DE, Martyak T, Pai V, Parks DE, Coller BA. Preclinical and clinical development of a dengue recombinant subunit vaccine. Vaccine. 2015 Dec 10;33(50):7126-34. doi: 10.1016/j.vaccine.2015.09.101. Epub 2015 Oct 14.
PubMed 26458804Durbin AP, Pierce KK, Kirkpatrick BD, Grier P, Sabundayo BP, He H, Sausser M, Russell AF, Martin J, Hyatt D, Cook M, Sachs JR, Lee AW, Wang L, Coller BA, Whitehead SS. Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. Am J Trop Med Hyg. 2020 Aug;103(2):855-863. doi: 10.4269/ajtmh.20-0042. Epub 2020 May 7.
PubMed 32394880
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01477580
- Acronym / sponsor ID
- V180-001
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2012 (actual)
- Primary completion
- 23 Jan 2014 (actual)
- Study completion
- 11 Dec 2014 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Low-dose V180 with low-dose ISCOMATRIX™ adjuvant | Experimental | Biological: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant | Experimental | Biological: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Medium-dose Non-adjuvanted V180 | Experimental | Biological: Medium-dose V180 (non-adjuvanted) |
| Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant | Experimental | Biological: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant | Experimental | Biological: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Medium-Dose V180 with Alhydrogel™ adjuvant | Experimental | Biological: Medium-dose V180 with Alhydrogel™ adjuvant |
| High-dose Non-adjuvanted V180 | Experimental | Biological: High-dose V180 (non-adjuvanted) |
| High-dose V180 with low-dose ISCOMATRIX™ adjuvant | Experimental | Biological: High-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| High-dose V180 with medium-dose ISCOMATRIX™ adjuvant | Experimental | Biological: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Low-dose V180 with high-dose ISCOMATRIX™ adjuvant | Experimental | Biological: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant | Experimental | Biological: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| High-dose V180 with high-dose ISCOMATRIX™ adjuvant | Experimental | Biological: High-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Low-dose V180 with low-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | Low-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| Low-dose V180 with medium-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 (non-adjuvanted)Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2 | Biological | Medium-dose Non-adjuvanted V180 |
| Medium-dose V180 with low-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 with Alhydrogel™ adjuvantThree 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2 | Biological | Medium-Dose V180 with Alhydrogel™ adjuvant |
| High-dose V180 (non-adjuvanted)Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2 | Biological | High-dose Non-adjuvanted V180 |
| High-dose V180 with low-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | High-dose V180 with low-dose ISCOMATRIX™ adjuvant |
| High-dose V180 with medium-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | High-dose V180 with medium-dose ISCOMATRIX™ adjuvant |
| Low-dose V180 with high-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | Low-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| Medium-dose V180 with high-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| High-dose V180 with high-dose ISCOMATRIX™ adjuvantThree 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2 | Biological | High-dose V180 with high-dose ISCOMATRIX™ adjuvant |
| PlaceboThree 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2 | Biological | Placebo |
Primary outcome
Seroconversion rate for each serotype
Time frame: 28 days postdose 3 (Day 84)
Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype
Time frame: 28 days postdose 3 (Day 84)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 30427741Manoff SB, Sausser M, Falk Russell A, Martin J, Radley D, Hyatt D, Roberts CC, Lickliter J, Krishnarajah J, Bett A, Dubey S, Finn T, Coller BA. Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naive adults. Hum Vaccin Immunother. 2019;15(9):2195-2204. doi: 10.1080/21645515.2018.1546523. Epub 2019 Jun 3.
- Results publication: PubMed 26458804Manoff SB, George SL, Bett AJ, Yelmene ML, Dhanasekaran G, Eggemeyer L, Sausser ML, Dubey SA, Casimiro DR, Clements DE, Martyak T, Pai V, Parks DE, Coller BA. Preclinical and clinical development of a dengue recombinant subunit vaccine. Vaccine. 2015 Dec 10;33(50):7126-34. doi: 10.1016/j.vaccine.2015.09.101. Epub 2015 Oct 14.
- Derived from this study: PubMed 32394880Durbin AP, Pierce KK, Kirkpatrick BD, Grier P, Sabundayo BP, He H, Sausser M, Russell AF, Martin J, Hyatt D, Cook M, Sachs JR, Lee AW, Wang L, Coller BA, Whitehead SS. Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. Am J Trop Med Hyg. 2020 Aug;103(2):855-863. doi: 10.4269/ajtmh.20-0042. Epub 2020 May 7.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low-dose V180 with low-dose ISCOMATRIX™ adjuvant, Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant and Medium-dose V180 (non-adjuvanted) in people with Dengue, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seroconversion rate for each serotype (time frame: 28 days postdose 3 (Day 84)). 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 NCT01477580, which also lists 3 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 15 Jan 2019.