InfluenzaPhase 2/3NCT00973349

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

A Phase 2/3 study testing MF59-eH1N1_f in people with Influenza, run by Novartis at 21 sites in 2 countries.

Completed

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

Trial summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: MF59-eH1N1_f
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,719 participants
Where: 21 sitesin 2 countries
Study dates: Sep 2009to Dec 2010
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Who cannot join

History of serious disease.
History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
Known or suspected impairment/alteration of immune function.
Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
For additional entry criteria, please refer to protocol.

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

United States20 sites

PI-Coor Clinical Research
Burke, Virginia, 22015
Triangle Medical Research Associates
Cary, North Carolina, 27518
Research Across America
Dallas, Texas, 75234
Regional Clinical Research
Endwell, New York, 13760
West Ridge Family Practice (adult)
Erie, Pennsylvania, 16506
PI Coor Clinical Research
Fairfax, Virginia, 22030
Prestige Clinical Research
Franklin, Ohio, 45005
West Houston Clinical Research Service
Houston, Texas, 77055
Primary Physicians Research Inc. (adult)
Jefferson Hills, Pennsylvania, 15025
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
IPS Research
Oklahoma City, Oklahoma, 73103
Meridien Clinical Research
Omaha, Nebraska, 68134
Triangle Medical Research Associates
Raleigh, North Carolina, 27609
Virginia Commonwealth University
Richmond, Virginia, 23219
Rochester Clinical Research, Inc
Rochester, New York, 14609
J.Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84121
Omega Clinical Research
Warwick, Rhode Island, 02886
Carolina Medical Trials
Winston-Salem, North Carolina, 27103

Other trials in United States

Mexico1 site

Instituto Nacional de Ciencias
Tlalpan, 14000

Other trials in Mexico

About this study

Official title: A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Conditions: Influenza
Being tested: MF59-eH1N1_f
Keywords: Swine Flu, Flu, Vaccine, Adults, Elderly, Non-Elderly, Adjuvant
Medical subject headings: Influenza, Human, Orthomyxoviridae Infections

What participants receive

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

MF59-eH1N1_fBiological
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant

Study groups in NCT00973349
Study group	Role	What they receive
3.75_(50)MF59	Experimental	50% of MF59 with 3.75 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f
7.5 w/o MF59	Experimental	0% of MF59 with 7.5 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f
7.5_(50)MF59	Experimental	50% of MF59 with 7.5 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f
7.5_(100)MF59	Experimental	100% of MF59 with 7.5 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f
15 w/o MF59	Experimental	0% of MF59 with 15 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f
15_(50)MF59	Experimental	50% of MF59 with 15 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f
15_(100)MF59	Experimental	100% of MF59 with 15 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f
30 w/o MF59	Experimental	0% of MF59 with 30 µg A/H1N1 antigen Receives: Biological: MF59-eH1N1_f

What is being measured

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

Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Measured: 21 days after each vaccination
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Measured: 21 days after each vaccination

Secondary outcomes (8)

Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Geometric mean hemagglutinin inhibition (HI) titer = GMT
Measured: 21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
Measured: 21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
Measured: 21 days after each vaccination
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
Measured: 21 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Measured: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Measured: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Measured: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Measured: 7 days after vaccination

Timeline

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

Sep 2009Dec 2010

First posted9 Sep 2009 (estimated)
Study startSep 2009
Primary completionNov 2009
Study completionDec 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.
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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 2,719 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00973349
Sponsor's protocol ID: V112_01
Status last verified: Oct 2015
First submitted: 2 Sep 2009
Last updated: 7 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
ClinicalTrials.gov ID: NCT00973349
Acronym / sponsor ID: V112_01
Conditions: Influenza
Keywords: Swine Flu, Flu, Vaccine, Adults, Elderly, Non-Elderly, Adjuvant
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,719 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Sep 2009
Primary completion: Nov 2009 (actual)
Study completion: Dec 2010 (actual)
First posted: 9 Sep 2009 (estimated)
Results: Posted 25 May 2011

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 evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
3.75_(50)MF59	Experimental	Biological: MF59-eH1N1_f50% of MF59 with 3.75 µg A/H1N1 antigen
7.5 w/o MF59	Experimental	Biological: MF59-eH1N1_f0% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(50)MF59	Experimental	Biological: MF59-eH1N1_f50% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(100)MF59	Experimental	Biological: MF59-eH1N1_f100% of MF59 with 7.5 µg A/H1N1 antigen
15 w/o MF59	Experimental	Biological: MF59-eH1N1_f0% of MF59 with 15 µg A/H1N1 antigen
15_(50)MF59	Experimental	Biological: MF59-eH1N1_f50% of MF59 with 15 µg A/H1N1 antigen
15_(100)MF59	Experimental	Biological: MF59-eH1N1_f100% of MF59 with 15 µg A/H1N1 antigen
30 w/o MF59	Experimental	Biological: MF59-eH1N1_f0% of MF59 with 30 µg A/H1N1 antigen

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Key exclusion criteria (6 listed)

History of serious disease.
History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
Known or suspected impairment/alteration of immune function.
Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.

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
MF59-eH1N1_f8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant	Biological	15 w/o MF59, 15_(100)MF59, 15_(50)MF59, 3.75_(50)MF59, 30 w/o MF59, 7.5 w/o MF59, 7.5_(100)MF59, 7.5_(50)MF59

Primary outcome

Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Time frame: 21 days after each vaccination
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Time frame: 21 days after each vaccination
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

8 secondary outcomes

Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Time frame: 21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Time frame: 21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Time frame: 21 days after each vaccination
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Time frame: 21 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Time frame: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Time frame: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Time frame: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Time frame: 7 days after vaccination

Results and safety

Results posted to the registry on 25 May 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
3.75_(50)MF59 (18-64 Years)	170	166
7.5 w/o MF59 (18-64 Years)	168	165
7.5_(50)MF59 (18-64 Years)	171	166
7.5_(100)MF59 (18-64 Years)	168	163
15 w/o MF59 (18-64 Years)	170	165
15_(50)MF59 (18-64 Years)	169	165
15_(100)MF59 (18-64 Years)	174	172
30 w/o MF59(18-64 Years)	169	166
3.75_(50)MF59 (≥ 65 Years)	171	167
7.5 w/o MF59 (≥ 65 Years)	169	163
7.5_(50)MF59 (≥ 65 Years)	174	174
7.5_(100)MF59 (≥ 65 Years)	169	167
15 w/o MF59 (≥ 65 Years)	169	168
15_(50)MF59 (≥ 65 Years)	171	171
15_(100)MF59 (≥ 65 Years)	170	168
30 w/o MF59(≥ 65 Years)	167	165

Primary outcome: Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age

Time frame: 21 days after each vaccination. Number. Unit: Participants

Measure	3.75_(50)MF59 n = 146	7.5 w/o MF59 n = 142	7.5_(50)MF59 n = 142	7.5_(100)MF59 n = 141	15 w/o MF59 n = 141	15_(50)MF59 n = 138	15_(100)MF59 n = 149	30 w/o MF59 n = 144
Seroprotection Day 22	129	126	135	134	133	135	147	141
Seroconversion Day 22	113	100	123	126	127	124	135	130
Seroprotection Day 43	138	133	136	137	135	137	145	142
Seroconversion Day 43	118	104	123	129	126	125	139	132
Seroprotection Day 202 (N=79,65,78,80,73,74,74,76)	68	51	67	70	56	59	65	69
Seroconversion Day 202 (N=79,65,78,80,73,74,74,76)	50	32	48	53	49	49	51	55
Seroprotection Day 387(N=105,95,88,84,91,91,106,84	76	78	66	67	66	74	89	69
Seroconversion Day387(N=105,95,88,84,91,91,106,84)	52	48	50	53	58	62	71	54

Population analysed: The analysis was based on the per protocol population.

Primary outcome: Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age

Time frame: 21 days after each vaccination. Number. Unit: Participants

Measure	3.75_(50)MF59 n = 150	7.5 w/o MF59 n = 147	7.5_(50)MF59 n = 164	7.5_(100)MF59 n = 148	15 w/o MF59 n = 159	15_(50)MF59 n = 155	15_(100)MF59 n = 154	30 w/o MF59 n = 150
Seroprotection Day 22	122	119	126	122	136	141	142	135
Seroconversion Day 22	89	76	102	92	104	110	111	108
Seroprotection Day 43	131	116	132	131	126	136	143	136
Seroconversion Day 43	90	75	103	95	94	106	113	103
Seroprotection Day 202 (N=80,71,85,79,84,82,87,82)	54	41	45	52	55	45	63	57
Seroconversion Day 202 (N=80,71,85,79,84,82,87,82)	31	16	30	31	35	27	38	36
Seroprotection Day 387(N=84,87,98,86,106,93,89,99)	50	56	55	57	67	55	65	69
Seroconversion Day 387(N=84,87,98,86,106,93,89,99)	30	25	26	33	37	30	47	32

Population analysed: The analysis was on the per protocol set.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All solicited AEs were collected for the first 3 weeks after each vaccination. SAEs, new onset of chronic diseases, AEs that led to withdrawal from study and AEs associated with medically attended visits, were collected for the whole study (days 1-387).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3.75_(50)MF59	5 of 170 (2.9%)	125 of 170 (73.5%)	Not reported
7.5 w/o MF59	5 of 168 (3%)	108 of 168 (64.3%)	Not reported
7.5_(50)MF59	5 of 171 (2.9%)	121 of 171 (70.8%)	Not reported
7.5_(100)MF59	5 of 165 (3%)	128 of 165 (77.6%)	Not reported
15 w/o MF59	6 of 170 (3.5%)	113 of 170 (66.5%)	Not reported
15_(50)MF59	6 of 169 (3.6%)	122 of 169 (72.2%)	Not reported
15_(100)MF59	5 of 174 (2.9%)	130 of 174 (74.7%)	Not reported
30 w/o MF59	7 of 168 (4.2%)	110 of 168 (65.5%)	Not reported
3.75_(50)MF59 (Above 65 Yrs)	9 of 170 (5.3%)	102 of 170 (60%)	Not reported
7.5 w/o MF59 (≥65 Yrs)	16 of 166 (9.6%)	88 of 166 (53%)	Not reported
7.5_(50)MF59 (≥65 Yrs)	18 of 173 (10.4%)	101 of 173 (58.4%)	Not reported
7.5_(100)MF59 (≥65 Yrs)	11 of 169 (6.5%)	118 of 169 (69.8%)	Not reported
15 w/o MF59 (≥ 65 Yrs)	12 of 169 (7.1%)	104 of 169 (61.5%)	Not reported
15_(50)MF59 (≥65 Yrs)	20 of 171 (11.7%)	109 of 171 (63.7%)	Not reported
15_(100)MF59 (≥65 Yrs)	14 of 169 (8.3%)	97 of 169 (57.4%)	Not reported
30 w/o MF59 (≥65 Yrs)	10 of 167 (6%)	99 of 167 (59.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Novartis Vaccine and Diagnostics study director

Novartis

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MF59-eH1N1_f in people with Influenza, run by Novartis at 21 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Mexico. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 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?

Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age (time frame: 21 days after each vaccination). 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 NCT00973349.

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 7 Dec 2015.