SmallpoxPhase 2NCT00316524
A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects
A Phase 2 study testing MVA-BN® (IMVAMUNE) in people with Smallpox, run by Bavarian Nordic at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects. In addition the study further investigates the cardiac safety profile of MVA-BN® in a healthy population compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- MVA-BN® (IMVAMUNE)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 745 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Aug 2007
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects between 18 and 55 years of age.
- Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
- Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
- Lab values without clinically significant findings
- Electrocardiogram (ECG) without abnormal findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV-node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, 2 premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia).
- Groups 1, 2 and 3 (All vaccinia-naïve subjects) additionally:
Show all 11Show fewer
- No history of known or suspected previous smallpox vaccination.
- No detectable vaccinia scar.
- Group 4 (All previously vaccinated subjects) additionally:
- History of previous smallpox vaccination (documented and/or typical vaccinia scar).
- Most recent smallpox vaccination ≥ 5 years.
Who cannot join
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
- History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
- History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
Show all 11Show fewer
- Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool. (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
- History of anaphylaxis or severe allergic reaction.
- Immune modulatory therapy.
- History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
- History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Partially Randomized, Partially Double-blind, Placebo-controlled Phase II Non-inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-55 Year Old Healthy Subjects
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.
In addition the study further investigates the cardiac safety profile of MVA-BN® in a healthy population compared to placebo.
Read the detailed description
The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.
- Conditions
- Smallpox
- Being tested
- MVA-BN® (IMVAMUNE), Placebo
- Keywords
- Smallpox, Vaccination, Prevention
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-BN® (IMVAMUNE)Biological
1x 10E8_TCID50
PlaceboBiological
Tris-Buffer
| Study group | Role | What they receive |
|---|---|---|
| GP 1: two x 1x10E08 TCID, MVA-BN® s.c., vaccinia naive | Experimental | vaccinia naive subjects receiving two subcutanenous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID) Receives: Biological: MVA-BN® (IMVAMUNE) |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., vaccinia naive | Experimental | vaccinica naive subjects receiving one vaccination with 0.5ml MVA-BN® IMVAMUNE(1x10E08 TCID), followed by one vaccination Placebo (0.5ml Tris Buffer) Receives: Biological: MVA-BN® (IMVAMUNE); Biological: Placebo |
| GP 3: two x Placebo, s.c., vaccinia naive | Placebo comparator | vaccinia naive subjects, receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer). Receives: Biological: Placebo |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., vaccinia experienced | Experimental | vaccinia experienced subjects, receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID). Receives: Biological: MVA-BN® (IMVAMUNE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Number of Participants With ECG Changes
Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6).
Measured: within 2 weeks after each vaccination
Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI])
Occurrence and relationship of any other cardiac symptom at any time during the study
Measured: within 32 weeks
Secondary outcomes (8)
Percentage of Participants With Seroconversion by ELISA
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Percentage of Participants With Seroconversion by PRNT
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Percentage of Participants With Seroconversion by PRNT
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Number of Participants With Related Serious Adverse Events
Number of participants with any serious adverse event possibly, probably or definitely related to the study vaccine at any time during the study
Measured: within 32 weeks
Number of Participants With Solicited Local Adverse Events
Number of participants with solicited local AEs (pain, erythema, swelling and induration) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.
Measured: within 8 days after any vaccination
Number of Participants With Solicited General Adverse Events
Number of participants with solicited systemic/general AEs (body temperature increased, headache, myalgia, nausea, and fatigue) within 8 days after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Percentages based on subjects with at least one completed diary card.
Measured: within 8 days after any vaccination
Number of Participants With Related Grade>=3 Adverse Events
Number of participants with any Grade >=3 AE probably, possibly, or definitely related to the study vaccine within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0). Pooled solicited (local and general) and unsolicited AEs.
Measured: within 4 weeks after any vaccination
Number of Participants With Unsolicited Non-serious Adverse Events
Number of participants with non-serious unsolicited AEs within 4 weeks after any vaccination (vaccinations for Groups 1-3: Days 0 and 28; Group 4: Day 0).
Measured: within 4 weeks after any vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2007
- Study completionAug 2007
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 SmallpoxStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank von Sonnenburg, Prof, Principal investigator, Section of International Medicine & Public Health, Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians Unviersity Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316524
- Sponsor's protocol ID
- POX-MVA-005
- Other IDs
- DMID 05-0128, EudraCT No. 2005-001781-14
- Status last verified
- Feb 2019
- First submitted
- 19 Apr 2006
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zitzmann-Roth EM, von Sonnenburg F, de la Motte S, Arndtz-Wiedemann N, von Krempelhuber A, Uebler N, Vollmar J, Virgin G, Chaplin P. Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population. PLoS One. 2015 Apr 16;10(4):e0122653. doi: 10.1371/journal.pone.0122653. eCollection 2015.
PubMed 25879867Ilchmann H, Samy N, Reichhardt D, Schmidt D, Powell JD, Meyer TPH, Silbernagl G, Nichols R, Weidenthaler H, De Moerlooze L, Chen L, Chaplin P. One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines. J Infect Dis. 2023 May 12;227(10):1203-1213. doi: 10.1093/infdis/jiac455.
PubMed 36408618
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially Randomized, Partially Double-blind, Placebo-controlled Phase II Non-inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-55 Year Old Healthy Subjects
- ClinicalTrials.gov ID
- NCT00316524
- Acronym / sponsor ID
- POX-MVA-005
- Conditions
- Smallpox
- Keywords
- Smallpox, Vaccination, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 745 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2006 (actual)
- Primary completion
- Feb 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Posted 9 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.
In addition the study further investigates the cardiac safety profile of MVA-BN® in a healthy population compared to placebo.
Detailed description
The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GP 1: two x 1x10E08 TCID, MVA-BN® s.c., vaccinia naive | Experimental | Biological: MVA-BN® (IMVAMUNE)vaccinia naive subjects receiving two subcutanenous vaccinations with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID) |
| GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., vaccinia naive | Experimental | Biological: MVA-BN® (IMVAMUNE), Biological: Placebovaccinica naive subjects receiving one vaccination with 0.5ml MVA-BN® IMVAMUNE(1x10E08 TCID), followed by one vaccination Placebo (0.5ml Tris Buffer) |
| GP 3: two x Placebo, s.c., vaccinia naive | Placebo comparator | Biological: Placebovaccinia naive subjects, receiving two subcutaneous vaccinations with Placebo (0.5ml Tris Buffer). |
| GP 4: 1x10E08 TCID, MVA-BN®, s.c., vaccinia experienced | Experimental | Biological: MVA-BN® (IMVAMUNE)vaccinia experienced subjects, receiving one subcutaneous vaccination with 0.5ml MVA-BN® IMVAMUNE (1x10E08 TCID). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female subjects between 18 and 55 years of age.
- Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
- Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
- Lab values without clinically significant findings
- Electrocardiogram (ECG) without abnormal findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV-node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, 2 premature ventricular contractions (PVC) in a row, ST elevation consistent with ischemia).
Key exclusion criteria (11 listed)
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
- History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
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 |
|---|---|---|
| MVA-BN® (IMVAMUNE)1x 10E8_TCID50 | Biological | GP 1: two x 1x10E08 TCID, MVA-BN® s.c., vaccinia naive, GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., vaccinia naive, GP 4: 1x10E08 TCID, MVA-BN®, s.c., vaccinia experienced |
| PlaceboTris-Buffer | Biological | GP 2: 1x10E08 TCID, MVA-BN®, 1x Placebo, s.c., vaccinia naive, GP 3: two x Placebo, s.c., vaccinia naive |
Primary outcome
Percentage of Participants With Seroconversion by ELISA
Time frame: 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Number of Participants With ECG Changes
Time frame: within 2 weeks after each vaccination
Occurrence of any specific or unspecific ECG change. Assessments at Screening (SCR), Visit 2 (Week 2) and Visit 4 (Week 6).
Number of Cardiac Adverse Events (Adverse Events of Special Interest [AESI])
Time frame: within 32 weeks
Occurrence and relationship of any other cardiac symptom at any time during the study
8 secondary outcomes
Percentage of Participants With Seroconversion by ELISA
Time frame: 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Percentage of Participants With Seroconversion by PRNT
Time frame: 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)
Percentage of Participants With Seroconversion by PRNT
Time frame: 4 weeks following the last vaccination (Week 8 for Groups 1-3, Week 4 for Group 4)
Number of Participants With Related Serious Adverse Events
Time frame: within 32 weeks
Number of Participants With Solicited Local Adverse Events
Time frame: within 8 days after any vaccination
Number of Participants With Solicited General Adverse Events
Time frame: within 8 days after any vaccination
Number of Participants With Related Grade>=3 Adverse Events
Time frame: within 4 weeks after any vaccination
Number of Participants With Unsolicited Non-serious Adverse Events
Time frame: within 4 weeks after any vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25879867Zitzmann-Roth EM, von Sonnenburg F, de la Motte S, Arndtz-Wiedemann N, von Krempelhuber A, Uebler N, Vollmar J, Virgin G, Chaplin P. Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population. PLoS One. 2015 Apr 16;10(4):e0122653. doi: 10.1371/journal.pone.0122653. eCollection 2015.
- Derived from this study: PubMed 36408618Ilchmann H, Samy N, Reichhardt D, Schmidt D, Powell JD, Meyer TPH, Silbernagl G, Nichols R, Weidenthaler H, De Moerlooze L, Chen L, Chaplin P. One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines. J Infect Dis. 2023 May 12;227(10):1203-1213. doi: 10.1093/infdis/jiac455.
Related trials for Smallpox
Active, not recruitingPhase 2
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
Smallpox
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
RecruitingPhase 2
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Mpox (Monkeypox), Smallpox
Enrolling by invitationObservational study
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
Complication of Smallpox Vaccination
Active, not recruitingPhase 3
Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC
Mpox (Monkeypox), Vaccination
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.
Frank von Sonnenburg, Prof principal investigator
Section of International Medicine & Public Health, Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians Unviersity Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-BN® (IMVAMUNE) in people with Smallpox, run by Bavarian Nordic at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 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 6 Mar 2019. 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 Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 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 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Seroconversion by ELISA (time frame: 2 weeks following the last vaccination (Week 6 for Groups 1-3, Week 2 for Group 4)). The study lists 3 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 NCT00316524, 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 6 Mar 2019.