InfluenzaPhase 4NCT00825162

Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years

A Phase 4 study testing CSL Limited Influenza Virus Vaccine in people with Influenza, run by Seqirus at 7 sites in Australia.

Completed

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

Official record

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Trial summary

A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years Read more about this study

Who is it for?: Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: CSL Limited Influenza Virus Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,992 participants
Where: 7 sitesAustralia
Study dates: Mar 2009to Feb 2010
Phase: Phase 4
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 6 months to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy male or female participants aged ≥ 6 months to < 18 years at the time of vaccination;
Written informed consent to participate in the study and adherence to all protocol requirements. Consent will be obtained from the participant, parent or guardian as appropriate according to the applicable Independent Ethics Committee (IEC) and local requirements. Participant assent will also be obtained if required by the applicable IEC;
Good health, as determined by medical history, and a targeted physical examination;
For participants aged < 9 years, born after a normal gestation period (between 36 and 42 weeks);
Females of childbearing potential (defined as having experienced their first menstrual cycle) must be abstinent or be using adequate contraceptive precautions e.g. intrauterine contraceptive device, oral contraceptive, or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives) for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrolment.

Who cannot join

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine;
Clinical signs of significant active infection and/or an elevated temperature (≥ 38.0°C oral or ≥ 37.5°C axillary) at study entry;
Vaccination against influenza virus in the previous 6 months with a seasonal IVV;
Vaccination with an experimental IVV (e.g. a candidate pandemic IVV or a novel IVV) in the previous 6 months;
Females of child bearing potential, planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of vaccination;
Pregnant or lactating females;

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Clinically significant medical or psychiatric conditions, as follows:
For acute conditions (active or recent), the condition required hospitalisation within the last month; or
For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month:
requiring hospitalisation; ii. with significant organ function deterioration; iii. with major changes to treatment dosages; iv. requiring major new treatments; or
The Investigator feels the participant has a clinical condition that may be adversely affected through study participation.
Confirmed or suspected immune deficiency (congenital or acquired, including cancer and human immunodeficiency virus infection);
History of seizures, with the exception of a past history of a single seizure event at any age more than two years previously;
Known history of Guillain-Barré Syndrome;
Current treatment with radiotherapy or cytotoxic drugs, or treatment within the 6 months prior to administration of the Study Vaccine;
Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
Chronic or long term corticosteroids: i. Age less than 9 years: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent daily; ii. Age 9 years and above: ≥ 15 mg/day of oral prednisolone or equivalent daily;
Sporadic corticosteroids: i. Age less than 9 years: ≥ 1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days in the 3 months preceding vaccination; ii. Age 9 years and above: ≥ 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination; Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study;
Current treatment with warfarin or other anticoagulants;
Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or entry into such a study during the on study period;
Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
If, in the Investigator's opinion, the participant should not take part in the clinical study.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Australia7 sites

The Canberra Hospital
Garran, Australian Capital Territory, 2606
Royal Children's Hospital
Herston, Queensland, 4006
Murdoch Children's Research Institute
Melbourne, Victoria, 3053
Women's & Children's Hospital Adelaide
North Adelaide, South Australia, 5006
Sydney Children's Clinical Trials Centre
Randwick, New South Wales, 2031
Princess Margaret Hospital
Subiaco, Western Australia, 6008
Children's Hospital at Westmead
Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years

A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years

Conditions: Influenza
Being tested: CSL Limited Influenza Virus Vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CSL Limited Influenza Virus VaccineBiological
Single or two-vaccination regimen (0.25mL)
CSL Limited Influenza Virus VaccineBiological
Single or two-vaccination regimen (0.5mL)
CSL Limited Influenza Virus VaccineBiological
Single vaccination regimen (0.5mL)

Study groups in NCT00825162
Study group	Role	What they receive
Cohort A	Experimental	Participants aged 6 months to less than 3 years Receives: Biological: CSL Limited Influenza Virus Vaccine
Cohort B	Experimental	Participants aged 3 years to less than 9 years Receives: Biological: CSL Limited Influenza Virus Vaccine
Cohort C	Experimental	Participants aged 9 years to less than 18 years Receives: Biological: CSL Limited Influenza Virus Vaccine

What is being measured

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

Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Measured: 7 days post-vaccination
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Measured: 7 days post-vaccination
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Measured: 7 days post-vaccination
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Measured: 7 days post-vaccination
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Measured: 7 days post-vaccination
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Measured: 7 days post-vaccination

Secondary outcomes (3)

Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE stands for Unsolicited Adverse Event.
Measured: 30 days after each study vaccination
Frequency of Serious Adverse Events
Measured: 180 days after the last study vaccination
Frequency of New Onsets of Chronic Illness
Measured: 180 days after the last study vaccination

Timeline

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

Mar 2009Feb 2010

First posted19 Jan 2009 (estimated)
Study startMar 2009
Primary completionFeb 2010
Study completionFeb 2010

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 InfluenzaStudies 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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,992 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00825162
Sponsor's protocol ID: CSLCT-USF-06-29
Status last verified: Apr 2018
First submitted: 15 Jan 2009
Last updated: 23 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lambert SB, Chuk LM, Nissen MD, Nolan TM, McVernon J, Booy R, Heron L, Richmond PC, Walls T, Marshall HS, Reynolds GJ, Hartel GF, Hu W, Lai MH. Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents. Influenza Other Respir Viruses. 2013 Sep;7(5):676-85. doi: 10.1111/irv.12107. Epub 2013 Apr 2.
PubMed 23551933

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 Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
ClinicalTrials.gov ID: NCT00825162
Acronym / sponsor ID: CSLCT-USF-06-29
Conditions: Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,992 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 19 Jan 2009 (estimated)
Results: Posted 29 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort A	Experimental	Biological: CSL Limited Influenza Virus VaccineParticipants aged 6 months to less than 3 years
Cohort B	Experimental	Biological: CSL Limited Influenza Virus VaccineParticipants aged 3 years to less than 9 years
Cohort C	Experimental	Biological: CSL Limited Influenza Virus VaccineParticipants aged 9 years to less than 18 years

Who may qualify

Ages: 6 months to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Healthy male or female participants aged ≥ 6 months to < 18 years at the time of vaccination;
Written informed consent to participate in the study and adherence to all protocol requirements. Consent will be obtained from the participant, parent or guardian as appropriate according to the applicable Independent Ethics Committee (IEC) and local requirements. Participant assent will also be obtained if required by the applicable IEC;
Good health, as determined by medical history, and a targeted physical examination;
For participants aged < 9 years, born after a normal gestation period (between 36 and 42 weeks);
Females of childbearing potential (defined as having experienced their first menstrual cycle) must be abstinent or be using adequate contraceptive precautions e.g. intrauterine contraceptive device, oral contraceptive, or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives) for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrolment.

Key exclusion criteria (23 listed)

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine;
Clinical signs of significant active infection and/or an elevated temperature (≥ 38.0°C oral or ≥ 37.5°C axillary) at study entry;
Vaccination against influenza virus in the previous 6 months with a seasonal IVV;
Vaccination with an experimental IVV (e.g. a candidate pandemic IVV or a novel IVV) in the previous 6 months;
Females of child bearing potential, planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of vaccination;

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
CSL Limited Influenza Virus VaccineSingle or two-vaccination regimen (0.25mL)	Biological	Cohort A
CSL Limited Influenza Virus VaccineSingle or two-vaccination regimen (0.5mL)	Biological	Cohort B
CSL Limited Influenza Virus VaccineSingle vaccination regimen (0.5mL)	Biological	Cohort C

Primary outcome

Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Time frame: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Time frame: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Time frame: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Time frame: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Time frame: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Time frame: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

3 secondary outcomes

Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Time frame: 30 days after each study vaccination
Frequency of Serious Adverse Events
Time frame: 180 days after the last study vaccination
Frequency of New Onsets of Chronic Illness
Time frame: 180 days after the last study vaccination

Results and safety

Results posted to the registry on 29 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A	710	682
Cohort B	880	859
Cohort C	402	396

Primary outcome: Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)

Time frame: 7 days post-vaccination. Number. Unit: Participants

Measure	After First Vaccination, Cohort A n = 703	After Second Vaccination, Cohort A n = 615
Any local solicited adverse event	254 (56.6% to 64.0%)	167
Any pain	160	111
Grade 3 pain	1	2
Any redness (> 0 mm)	148	109
Grade 3 redness (> 30 mm)	2	1
Any swelling / induration (> 0 mm)	66	64
Grade 3 swelling / induration (> 30 mm)	2	0
Any systemic solicited adverse event	424	261

Population analysed: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.

Primary outcome: Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)

Time frame: 7 days post-vaccination. Mean (Standard Deviation). Unit: Days

Measure	After First Vaccination, Cohort A n = 703	After Second Vaccination, Cohort A n = 615
Any pain	1.83 (1.264)	1.76 (1.315)
Any redness (> 0 mm)	2.55 (1.930)	2.74 (2.478)
Any swelling / induration (> 0 mm)	3.06 (4.011)	3.20 (3.301)
Any fever (≥99.5°F axillary or ≥100.4 °F oral)	1.54 (1.164)	1.67 (1.148)
Any headache	2.50 (4.492)	1.23 (0.439)
Any myalgia	1.54 (1.071)	1.70 (1.129)
Any nausea / vomiting	1.87 (2.587)	2.84 (4.919)
Any diarrhea	2.43 (3.473)	2.50 (2.573)

Primary outcome: Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)

Time frame: 7 days post-vaccination. Number. Unit: Participants

Measure	After First Vaccination, Cohort B n = 875	After Second Vaccination, Cohort B n = 634
Any local solicited adverse event	512	312
Any pain	463	282
Grade 3 pain	2	2
Any redness (> 0 mm)	189	109
Grade 3 redness (> 30 mm)	18	7
Any swelling / induration (> 0 mm)	137	77
Grade 3 swelling / induration (> 30 mm)	19	8
Any systemic solicited adverse event	346	157

Primary outcome: Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)

Time frame: 7 days post-vaccination. Mean (Standard Deviation). Unit: Days

Measure	After First Vaccination, Cohort B n = 875	After Second Vaccination, Cohort B n = 634
Any pain	1.89 (1.178)	1.68 (1.030)
Any redness (> 0 mm)	2.45 (1.713)	2.21 (1.316)
Any swelling / induration (> 0 mm)	2.48 (1.688)	2.09 (1.696)
Any fever (≥99.5°F axillary or ≥100.4 °F oral)	1.40 (1.114)	1.58 (1.117)
Any headache	1.79 (1.373)	1.66 (1.311)
Any myalgia	1.74 (1.264)	1.38 (0.590)
Any nausea / vomiting	1.52 (1.305)	1.36 (0.757)
Any diarrhea	2.00 (1.593)	2.00 (1.612)

Population analysed: The Safety Population comprised all participants who received CSL's IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs were collected up to 180 days after the last study vaccination. Other adverse events were unsolicited adverse events that were collected up to 30 days after the study vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A	19 of 703 (2.7%)	531 of 703 (75.5%)	Not reported
Cohort B	5 of 875 (0.6%)	467 of 875 (53.4%)	Not reported
Cohort C	2 of 398 (0.5%)	97 of 398 (24.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23551933Lambert SB, Chuk LM, Nissen MD, Nolan TM, McVernon J, Booy R, Heron L, Richmond PC, Walls T, Marshall HS, Reynolds GJ, Hartel GF, Hu W, Lai MH. Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents. Influenza Other Respir Viruses. 2013 Sep;7(5):676-85. doi: 10.1111/irv.12107. Epub 2013 Apr 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.

Stephen Lambert, Dr principal investigator

Royal Children's Hospital, Brisbane, Herston, QLD, Australia

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CSL Limited Influenza Virus Vaccine in people with Influenza, run by Seqirus at 7 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 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 23 May 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 29 Jul 2011). 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?

Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) (time frame: 7 days post-vaccination). The study lists 6 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 NCT00825162, 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 23 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.