MalariaPhase 2NCT00360230
Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
A Phase 2 study testing GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 and Rabipur in people with Malaria, run by GlaxoSmithKline at 2 sites in Ghana.
Trial summary
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study
- Who is it for?
- Ages 5 to 17 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 and Rabipur
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 2 sitesGhana
- Study dates
- 30 Aug 2006to 30 May 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 5 to 17 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female child between 5 months and 17 months of age at the time of first vaccination.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
Who cannot join
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
- Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
- Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Show all 13Show fewer
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Simultaneous participation in any other clinical trial;
- Previous participation in any other malaria vaccine trial;
- Any twins
- History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.
- Conditions
- Malaria
- Being tested
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Rabipur
- Keywords
- Vaccine, Prophylaxis Plasmodium falciparum malaria, Plasmodium falciparum, Malaria
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Biological
Also called RTS, S vaccine
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
RabipurBiological
3-dose intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| SB257049 F2 0-1 M Group | Experimental | Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
| SB257049 F1 0-1 M Group | Experimental | Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
| SB257049 F2 0-1-2 M Group | Experimental | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
| SB257049 F1 0-1-2 M Group | Experimental | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
| SB257049 F2 0-1-7 M Group | Experimental | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
| SB257049 F1 0-1-7 M Group | Active comparator | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. Receives: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
| Rabipur 0-1-2 M Group | Active comparator | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. Receives: Biological: Rabipur |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: From Day 0 to Month 10
Secondary outcomes (5)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 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 (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
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: During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)
Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: At Day 0, at Month 2, at Month 7 and at Month 10
Titers for Anti-Hepatitis B (Anti-HBs)
Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL).
Measured: At Day 0 and at Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study start30 Aug 2006
- Primary completion25 Aug 2007
- Study completion30 May 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 MalariaStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 540 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
- NCT00360230
- Sponsor's protocol ID
- 106367
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2006
- Last updated
- 19 Feb 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
Ansong D, Asante KP, Vekemans J, Owusu SK, Owusu R, Brobby NA, Dosoo D, Osei-Akoto A, Osei-Kwakye K, Asafo-Adjei E, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Janssens MH, Lievens MJ, Olivier AC, Jongert E, Dubois P, Savarese BM, Cohen J, Antwi S, Greenwood BM, Evans JA, Agbenyega T, Moris PJ, Owusu-Agyei S. T cell responses to the RTS,S/AS01(E) and RTS,S/AS02(D) malaria candidate vaccines administered according to different schedules to Ghanaian children. PLoS One. 2011 Apr 27;6(4):e18891. doi: 10.1371/journal.pone.0018891.
PubMed 21556142Owusu-Agyei S, Ansong D, Asante K, Kwarteng Owusu S, Owusu R, Wireko Brobby NA, Dosoo D, Osei Akoto A, Osei-Kwakye K, Adjei EA, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Vekemans J, Ofori-Anyinam O, Leach A, Lievens M, Demoitie MA, Dubois MC, Cohen J, Ballou WR, Savarese B, Chandramohan D, Gyapong JO, Milligan P, Antwi S, Agbenyega T, Greenwood B, Evans J. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 2009 Oct 2;4(10):e7302. doi: 10.1371/journal.pone.0007302.
PubMed 19806184
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana
- ClinicalTrials.gov ID
- NCT00360230
- Acronym / sponsor ID
- 106367
- Conditions
- Malaria
- Keywords
- Vaccine, Prophylaxis Plasmodium falciparum malaria, Plasmodium falciparum, Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2006 (actual)
- Primary completion
- 25 Aug 2007 (actual)
- Study completion
- 30 May 2008 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Posted 19 Feb 2018
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 investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SB257049 F2 0-1 M Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1 M Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F2 0-1-2 M Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1-2 M Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F2 0-1-7 M Group | Experimental | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1-7 M Group | Active comparator | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| Rabipur 0-1-2 M Group | Active comparator | Biological: RabipurHealthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
Who may qualify
- Ages
- 5 to 17 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A male or female child between 5 months and 17 months of age at the time of first vaccination.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
Key exclusion criteria (13 listed)
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
- Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
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 |
|---|---|---|
| GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049Also: RTS, S vaccine2 different formulations are tested. For each formulation, 3 different dosing schedules are tested | Biological | SB257049 F1 0-1 M Group, SB257049 F1 0-1-2 M Group, SB257049 F1 0-1-7 M Group, SB257049 F2 0-1 M Group, SB257049 F2 0-1-2 M Group, SB257049 F2 0-1-7 M Group |
| Rabipur3-dose intramuscular injection. | Biological | Rabipur 0-1-2 M Group |
Primary outcome
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 to Month 10
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.
5 secondary outcomes
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)
Time frame: At Day 0, at Month 2, at Month 7 and at Month 10
Titers for Anti-Hepatitis B (Anti-HBs)
Time frame: At Day 0 and at Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21556142Ansong D, Asante KP, Vekemans J, Owusu SK, Owusu R, Brobby NA, Dosoo D, Osei-Akoto A, Osei-Kwakye K, Asafo-Adjei E, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Janssens MH, Lievens MJ, Olivier AC, Jongert E, Dubois P, Savarese BM, Cohen J, Antwi S, Greenwood BM, Evans JA, Agbenyega T, Moris PJ, Owusu-Agyei S. T cell responses to the RTS,S/AS01(E) and RTS,S/AS02(D) malaria candidate vaccines administered according to different schedules to Ghanaian children. PLoS One. 2011 Apr 27;6(4):e18891. doi: 10.1371/journal.pone.0018891.
- Background: PubMed 19806184Owusu-Agyei S, Ansong D, Asante K, Kwarteng Owusu S, Owusu R, Wireko Brobby NA, Dosoo D, Osei Akoto A, Osei-Kwakye K, Adjei EA, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Vekemans J, Ofori-Anyinam O, Leach A, Lievens M, Demoitie MA, Dubois MC, Cohen J, Ballou WR, Savarese B, Chandramohan D, Gyapong JO, Milligan P, Antwi S, Agbenyega T, Greenwood B, Evans J. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 2009 Oct 2;4(10):e7302. doi: 10.1371/journal.pone.0007302.
- 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 Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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
2 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 GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 and Rabipur in people with Malaria, run by GlaxoSmithKline at 2 sites in Ghana.
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 4 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana. 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 19 Feb 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 Serious Adverse Events (SAEs) (time frame: From Day 0 to Month 10). 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 NCT00360230, 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 19 Feb 2018.