Vaccines, PneumococcalPhase 3NCT00474539

Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 27 sites in Spain.

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

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain. Read more about this study

Who is it for?: Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal
What is being tested?: 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 449 participants
Where: 27 sitesSpain
Study dates: Jul 2007to Mar 2009
Phase: Phase 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 42 to 98 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy 2-month-old infants
Available for the entire study period

Who cannot join

Previous vaccination with any vaccine before the start of the study
Known contraindication to vaccination

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

Spain27 sites

Study site
A Coruña, 15270
Study site
A Coruña, 15405
Study site
Almería, 4007
Study site
Almería, 4009
Study site
Almería, 4120
Study site
Barcelona, 8195
Study site
Barcelona, 8930
Study site
Madrid, 28041
Study site
Madrid, 28900
Study site
Madrid, 28922
Study site
Madrid, 28942
Study site
Málaga, 29015
Study site
Málaga, 29200
Study site
Ourense, 32005
Study site
Pamplona, 31008
Study site
Santiago de Compostela, 15706
Study site
Seville, 41013
Study site
Valencia, 46008
Study site
Valencia, 46011
Study site
Valencia, 46021
Study site
Valencia, 46022
Study site
Valencia, 46023
Study site
Valencia, 46024
Study site
Valencia, 46183
Study site
Valencia, 46200
Study site
Valencia, 46930
Study site
Vigo, 36204

Other trials in Spain

About this study

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain

Conditions: Vaccines, Pneumococcal
Being tested: 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine
Keywords: Vaccine

What participants receive

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

13-valent pneumococcal conjugate vaccineBiological
1 dose at 2,4,6 and 15 months of age
7-valent pneumococcal conjugate vaccineBiological
1 dose at 2,4,6 and 15 months of age

Study groups in NCT00474539
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: 13-valent pneumococcal conjugate vaccine
2	Active comparator	Not described Receives: Biological: 7-valent pneumococcal conjugate vaccine

What is being measured

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

Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Measured: One month after infant series dose (at 5 months of age)
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
Measured: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).
Measured: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Measured: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Measured: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
Measured: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)

Secondary outcomes (1)

Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Measured: One month after toddler dose (at 16 months of age)

Timeline

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

Jul 2007Mar 2009

First posted17 May 2007 (estimated)
Study startJul 2007
Primary completionMar 2009
Study completionMar 2009

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 Vaccines, PneumococcalStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 449 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00474539
Sponsor's protocol ID: 6096A1-3007
Status last verified: Jan 2013
First submitted: 15 May 2007
Last updated: 5 Mar 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
PubMed 23965217

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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Active, not recruitingPhase 1
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Pneumococcal Disease
Enrolling by invitation
Randomized Controlled Trial Of Text Messages To Increase Pneumococcal Vaccination In Adults In Chile.
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Enrolling by invitationObservational study
Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage in Vietnamese Children
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All Vaccines, Pneumococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
ClinicalTrials.gov ID: NCT00474539
Acronym / sponsor ID: 6096A1-3007
Conditions: Vaccines, Pneumococcal
Keywords: Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 449 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 17 May 2007 (estimated)
Results: Posted 5 Mar 2013

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine
2	Active comparator	Biological: 7-valent pneumococcal conjugate vaccine

Who may qualify

Ages: 42 to 98 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy 2-month-old infants
Available for the entire study period

Key exclusion criteria (2 listed)

Previous vaccination with any vaccine before the start of the study
Known contraindication to 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
13-valent pneumococcal conjugate vaccine1 dose at 2,4,6 and 15 months of age	Biological	1
7-valent pneumococcal conjugate vaccine1 dose at 2,4,6 and 15 months of age	Biological	2

Primary outcome

Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series
Time frame: One month after infant series dose (at 5 months of age)
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose
Time frame: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Time frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose
Time frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Time frame: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.

1 secondary outcome

Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: One month after toddler dose (at 16 months of age)

Results and safety

Results posted to the registry on 5 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC	223	213
7vPnC	226	220

Primary outcome: Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series

Time frame: One month after infant series dose (at 5 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC After Infant Series Dose 2 n = 206	7vPnC After Infant Series Dose 2 n = 218
Value	98.5 (95.8 to 99.7)	99.1 (96.7 to 99.9)

13vPnC After Infant Series Dose 2 vs 7vPnC After Infant Series Dose 2: Difference: -0.5 (95% CI -3.3 to 2.0)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.

Primary outcome: Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose

Time frame: One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age). Geometric mean (95% Confidence Interval). Unit: titer

Measure	13vPnC After Infant Series Dose 2 n = 206	7vPnC After Infant Series Dose 2 n = 218	13vPnC After Toddler Dose n = 164	7vPnC After Toddler Dose n = 172
Value	654.55 (557.75 to 768.16)	757.04 (648.45 to 883.81)	2573.06 (2176.29 to 3042.16)	2098.12 (1779.65 to 2473.58)

13vPnC After Infant Series Dose 2 vs 7vPnC After Infant Series Dose 2: Ratio: 0.86 (95% CI 0.69 to 1.08)
13vPnC After Toddler Dose vs 7vPnC After Toddler Dose: Ratio: 1.23 (95% CI 0.97 to 1.55)

Population analysed: The evaluable 2-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Primary outcome: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose

Time frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC After Infant Series Dose 3 n = 197	7vPnC After Infant Series Dose 3 n = 212	13vPnC After Toddler Dose n = 164	7vPnC After Toddler Dose n = 172
Diphtheria ≥0.10 IU/mL	98.5 (95.6 to 99.7)	99.1 (96.6 to 99.9)	100.0 (97.8 to 100.0)	100.0 (97.9 to 100.0)
Diphtheria ≥0.01 IU/mL	100.0 (98.1 to 100.0)	100.0 (98.3 to 100.0)	100.0 (97.8 to 100.0)	100.0 (97.9 to 100.0)
Tetanus ≥0.10 IU/mL	96.6 (92.6 to 98.7)	96.7 (93.0 to 98.8)	100.0 (97.8 to 100.0)	100.0 (97.9 to 100.0)
Tetanus ≥0.01 IU/mL	100.0 (97.9 to 100.0)	100.0 (98.0 to 100.0)	100.0 (97.8 to 100.0)	100.0 (97.9 to 100.0)

13vPnC After Infant Series Dose 3 vs 7vPnC After Infant Series Dose 3: Difference: -0.6 (95% CI -3.5 to 2.0)
13vPnC After Infant Series Dose 3 vs 7vPnC After Infant Series Dose 3: Difference: 0.0 (95% CI -1.9 to 1.7)
13vPnC After Infant Series Dose 3 vs 7vPnC After Infant Series Dose 3: Difference: -0.2 (95% CI -4.4 to 4.0)

Population analysed: The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Primary outcome: Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose

Time frame: One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	13vPnC After Infant Series Dose 3 n = 197	7vPnC After Infant Series Dose 3 n = 212	13vPnC After Toddler Dose n = 164	7vPnC After Toddler Dose n = 172
Diphtheria	0.79 (0.69 to 0.90)	0.92 (0.81 to 1.04)	3.00 (2.63 to 3.41)	3.23 (2.88 to 3.63)
Tetanus	1.10 (0.94 to 1.27)	1.20 (1.04 to 1.39)	3.29 (2.83 to 3.83)	3.28 (2.83 to 3.79)

13vPnC After Infant Series Dose 3 vs 7vPnC After Infant Series Dose 3: Ratio: 0.86 (95% CI 0.72 to 1.03)
13vPnC After Infant Series Dose 3 vs 7vPnC After Infant Series Dose 3: Ratio: 0.91 (95% CI 0.74 to 1.12)
13vPnC After Toddler Dose vs 7vPnC After Toddler Dose: Ratio: 0.93 (95% CI 0.78 to 1.10)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	6 of 218 (2.8%)	204 of 218 (93.6%)	Not reported
7vPnC Infant Series	8 of 226 (3.5%)	211 of 225 (93.8%)	Not reported
13vPnC Post-Infant Series	9 of 218 (4.1%)	6 of 218 (2.8%)	Not reported
7vPnC Post-Infant Series	6 of 226 (2.7%)	13 of 225 (5.8%)	Not reported
13vPnC Toddler Series	1 of 218 (0.5%)	171 of 209 (81.8%)	Not reported
7vPnC Toddler Series	0 of 226 (0%)	179 of 218 (82.1%)	Not reported
13vPnC 6-Month Follow-up	4 of 218 (1.8%)	4 of 218 (1.8%)	Not reported
7vPnC 6-Month Follow-up	9 of 226 (4%)	2 of 224 (0.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23965217Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

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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.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager principal investigator

For Spain: infomed@wyeth.com

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

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 2 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 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain. 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 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 5 Mar 2013). 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 Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series (time frame: One month after infant series dose (at 5 months of age)). 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 NCT00474539, 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 5 Mar 2013.