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InfluenzaPhase 3NCT01198756

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

A Phase 3 study testing Quadrivalent seasonal influenza vaccine GSK2282512A, Fluarix™ VB and Fluarix™ YB in people with Influenza, run by GlaxoSmithKline at 33 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines. 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?
Quadrivalent seasonal influenza vaccine GSK2282512A, Fluarix™ VB and Fluarix™ YB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,109 participants
Where
33 sitesin 5 countries
Study dates
1 Oct 2010to 1 Jul 2011
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 6 months to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
  • A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
  • Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
  • Written informed assent obtained from the subject if/as required by local regulations.
  • Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
  • Female subjects of non-childbearing potential may be enrolled in the study.
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  • Female subjects of childbearing potential may be enrolled in the study, if the subject
  • Has practiced adequate contraception for 30 days prior to vaccination, and
  • Has a negative pregnancy urine test on the day of vaccination, and
  • Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Who cannot join

  • Child in care
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
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  • Fever at the time of enrolment.
  • Acute disease at the time of enrolment.
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Ongoing aspirin therapy.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Trial locations and contacts

33 sites in 5 countries.

33 sites in 5 countries

United States16 sites

  • GSK Investigational Site

    Barnwell, South Carolina, 29812

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Fort Worth, Texas, 76135

  • GSK Investigational Site

    Harrisburg, Arkansas, 72432

  • GSK Investigational Site

    Hermitage, Pennsylvania, 16148

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Longmont, Colorado, 80501

  • GSK Investigational Site

    Niles, Michigan, 49120

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Scottsdale, Arizona, 85288

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Thornton, Colorado, 80233

Other trials in United States

Canada9 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2C8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 6R8

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G8

  • GSK Investigational Site

    Mount Pearl, Newfoundland and Labrador, A1N 5B6

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7K 3H3

  • GSK Investigational Site

    Surrey, British Columbia, V3R 8P8

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Spain4 sites

  • GSK Investigational Site

    Alcalá de Guadaira, 41500

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Seville, 41014

Other trials in Spain

Mexico2 sites

  • GSK Investigational Site

    Mexico City, 04530

  • GSK Investigational Site

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Taiwan2 sites

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

Conditions
Influenza
Being tested
Quadrivalent seasonal influenza vaccine GSK2282512A, Fluarix™ VB, Fluarix™ YB
Keywords
Influenza
Medical subject headings
Influenza, Human

What participants receive

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

  • Quadrivalent seasonal influenza vaccine GSK2282512ABiological

    For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.

  • Fluarix™ VBBiological

    For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.

  • Fluarix™ YBBiological

    For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose

  • Quadrivalent seasonal influenza vaccine GSK2282512ABiological

    Single intramuscular dose for primed subjects, two doses for unprimed subjects.

Study groups in NCT01198756
Study groupRoleWhat they receive
GSK2282512A 1 GroupExperimentalSubjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
Victoria strain Fluarix GroupActive comparatorSubjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Fluarix™ VB
Yamagata strain Fluarix GroupActive comparatorSubjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Fluarix™ YB
GSK2282512A 2 GroupExperimentalSubjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Receives: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A

What is being measured

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

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

    Measured: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  2. Number of Subjects Seroconverted Against 4 Strains of Influenza Disease

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

    Measured: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Secondary outcomes (18)

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

    Measured: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  2. Number of Subjects Seroprotected Against 4 Strains of Influenza Disease

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.

    Measured: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  3. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains

    Measured: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  4. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

    Measured: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  5. Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

    Measured: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  6. Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

    Measured: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  7. Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

    Measured: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

  8. Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).

    Measured: During the 7-day follow-up period (Days 0-6) after vaccination

  9. Number of Days With Solicited Local Symptoms After Vaccination

    Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.

    Measured: During the 7-day follow-up period (Days 0-6) after vaccination

  10. Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms

    Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.

    Measured: During the 7-day follow-up period (Days 0-6) after vaccination

  11. Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms

    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.

    Measured: During the 7-day follow-up period (Days 0-6) after vaccination

  12. Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age

    Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.

    Measured: During the 7-day follow-up period (Days 0-6) after vaccination

  13. Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above

    Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.

    Measured: During the 7-day follow-up period (Days 0-6) after vaccination

  14. Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination

    Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.

    Measured: During the 7-day follow-up period (Days 0-6) after vaccination

  15. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    Unsolicited AE covers any AE 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 unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.

    Measured: During the 28-day follow-up period (Day 0-27) after vaccination

  16. Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination

    Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

    Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination.

    Measured: During the entire study period (from Day 0 to Day 180)

  17. Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination

    Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.

    Measured: During the entire study period (from Day 0 to Day 180)

  18. Number of Subjects With Any and Related Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

    Measured: During the entire study period (from Day 0 to Day 180)

Timeline

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

  1. First posted10 Sep 2010 (estimated)
  2. Study start1 Oct 2010
  3. Primary completion1 Jul 2011
  4. Study completion1 Jul 2011

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
3,109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01198756
Sponsor's protocol ID
113314
Status last verified
Apr 2018
First submitted
9 Sep 2010
Last updated
21 Sep 2018
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

  • Langley JM, Carmona Martinez A, Chatterjee A, Halperin SA, McNeil S, Reisinger KS, Aggarwal N, Huang LM, Peng CT, Garcia-Sicilia J, Salamanca de la Cueva I, Cabanas F, Trevino-Garza C, Rodriguez-Weber MA, de la O M, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. J Infect Dis. 2013 Aug 15;208(4):544-53. doi: 10.1093/infdis/jit263. Epub 2013 Jul 11.

    PubMed 23847058

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent seasonal influenza vaccine GSK2282512A, Fluarix™ VB and Fluarix™ YB in people with Influenza, run by GlaxoSmithKline at 33 sites in 5 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 10 inclusion and 14 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada, Spain, Mexico, Taiwan. 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 12 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?

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease (time frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)). 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 NCT01198756, 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 21 Sep 2018.

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