Infections, MeningococcalPhase 3NCT01154088

Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

A Phase 3 study testing Mencevax ACWY and GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] in people with Infections, Meningococcal, run by GlaxoSmithKline at 3 sites in 3 countries.

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 the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. Read more about this study

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: Mencevax ACWY and GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,170 participants
Where: 3 sitesin 3 countries
Study dates: 27 Aug 2010to 30 Dec 2010
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 18 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

All subjects must satisfy all of the following criteria at study entry:
Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
A male or female between, and including, 18 and 25 years of age the time of the vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.

Show all 10Show fewer

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 test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.

Who cannot join

The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the 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 vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).
Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine.
Previous vaccination with meningococcal polysaccharide vaccine within the last five years.
Previous vaccination with meningococcal conjugate vaccine.

Show all 21Show fewer

Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month.
History of meningococcal disease.
Seropositive for HIV or HBsAg (for subjects in the Philippines only).
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient has been demonstrated.
History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
History of any neurologic disorders, including Guillain-Barré Syndrome.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Panama1 site

GSK Investigational Site
Panama City

Other trials in Panama

Philippines1 site

GSK Investigational Site
City of Muntinlupa

Other trials in Philippines

Thailand1 site

GSK Investigational Site
Bangkok, 10400

Other trials in Thailand

About this study

Official title: Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Mencevax™ ACWY in Healthy Subjects Aged 18-25 Years

Conditions: Infections, Meningococcal
Being tested: Mencevax ACWY, GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Keywords: Adolescent, Vaccine, conjugate, Adult, Neisseria meningitidis, Immunogenicity, Meningococcal vaccine, Safety
Medical subject headings: Meningococcal Infections

What participants receive

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

Mencevax ACWYBiological
One dose, Subcutaneous injection
GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]Biological
One dose, Intramuscular injection

Study groups in NCT01154088
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Group B	Experimental	Not described Receives: Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Group C	Active comparator	Not described Receives: Biological: Mencevax ACWY

What is being measured

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

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
Measured: At Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
Measured: At Month 1

Secondary outcomes (10)

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Measured: At Day 0 and at Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Measured: At Day 0 and Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs). The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Measured: At Day 0 and at Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the GSK rSBA assay.
Measured: At Day 0 and at Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs). The analysis was performed with the GSK rSBA assay.
Measured: At Day 0
Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Measured: At Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Measured: Within 4-days (Days 0-3) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within 4-days (Days 0-3) post-vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Within 31-days (Days 0-30) post-vaccination
Number of Subjects With New Onset Chronic Illnesses (NOCI)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: Within 31-days (Days 0-30) post-vaccination

Timeline

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

27 Aug 201030 Dec 2010

First posted30 Jun 2010 (estimated)
Study start27 Aug 2010
Primary completion30 Dec 2010
Study completion30 Dec 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 Infections, MeningococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01154088
Sponsor's protocol ID: 114248
Status last verified: May 2018
First submitted: 29 Jun 2010
Last updated: 26 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Lupisan S, Limkittikul K, Sosa N, Chanthavanich P, Bianco V, Baine Y, Van der Wielen M, Miller JM. Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years. Clin Vaccine Immunol. 2013 Oct;20(10):1499-507. doi: 10.1128/CVI.00162-13. Epub 2013 Jul 24.
PubMed 23885033

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 Infections, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Mencevax™ ACWY in Healthy Subjects Aged 18-25 Years
ClinicalTrials.gov ID: NCT01154088
Acronym / sponsor ID: 114248
Conditions: Infections, Meningococcal
Keywords: Adolescent, Vaccine, conjugate, Adult, Neisseria meningitidis, Immunogenicity, Meningococcal vaccine, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,170 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Aug 2010
Primary completion: 30 Dec 2010 (actual)
Study completion: 30 Dec 2010 (actual)
First posted: 30 Jun 2010 (estimated)
Results: Posted 26 Nov 2018

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Group B	Experimental	Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Group C	Active comparator	Biological: Mencevax ACWY

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
A male or female between, and including, 18 and 25 years of age the time of the vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.

Key exclusion criteria (21 listed)

The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the 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 vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).
Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine.
Previous vaccination with meningococcal polysaccharide vaccine within the last five years.

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
Mencevax ACWYOne dose, Subcutaneous injection	Biological	Group C
GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]One dose, Intramuscular injection	Biological	Group A, Group B

Primary outcome

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
Time frame: At Month 1
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Time frame: At Month 1
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.

10 secondary outcomes

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Time frame: At Day 0 and at Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Time frame: At Day 0 and Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Time frame: At Day 0 and at Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
Time frame: At Day 0 and at Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Time frame: At Day 0
Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Time frame: At Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within 4-days (Days 0-3) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within 4-days (Days 0-3) post-vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 31-days (Days 0-30) post-vaccination
Number of Subjects With New Onset Chronic Illnesses (NOCI)
Time frame: Within 31-days (Days 0-30) post-vaccination

Results and safety

Results posted to the registry on 26 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nimenrix-A Group	390	386
Nimenrix-B Group	390	384
Mencevax Group	390	383

Primary outcome: Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies

Time frame: At Month 1. Count of participants. Unit: Participants

Measure	Nimenrix-A Group n = 358	Nimenrix-B Group n = 353	Mencevax Group n = 357
rSBA-MenA	239	238	216
rSBA-MenC	324	327	332
rSBA-MenW-135	328	312	304
rSBA-MenY	334	324	308

Nimenrix-A Group vs Mencevax Group: Difference in vaccine response rate: 5.42 (95% CI -1.41 to 12.25)
Nimenrix-A Group vs Mencevax Group: Difference in vaccine response rate: -0.41 (95% CI -4.11 to 3.25)
Nimenrix-A Group vs Mencevax Group: Difference in vaccine response rate: 6.83 (95% CI 3.28 to 10.78)

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Mencevax Group only.

Primary outcome: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers

Time frame: At Month 1. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Nimenrix-A Group n = 375	Nimenrix-B Group n = 371	Mencevax Group n = 373
rSBA-MenA	4846.0 (4459.8 to 5265.7)	5064.6 (4657.5 to 5507.2)	3421.0 (3134.7 to 3733.4)
rSBA-MenC	6025.4 (5269.0 to 6890.2)	7070.7 (6225.3 to 8030.9)	5953.1 (5188.2 to 6830.7)
rSBA-MenW-135	9836.7 (8939.2 to 10824.3)	8855.5 (8021.8 to 9775.9)	4675.1 (4145.9 to 5272.0)
rSBA-MenY	11632.5 (10675.1 to 12675.8)	10386.7 (9557.5 to 11287.9)	6315.9 (5787.9 to 6892.1)

Nimenrix-A Group vs Nimenrix-B Group: Adjusted GMT ratio: 1.04 (95% CI 0.92 to 1.17)
Nimenrix-A Group vs Nimenrix-B Group: Adjusted GMT ratio: 1.15 (95% CI 0.96 to 1.37)
Nimenrix-A Group vs Nimenrix-B Group: Adjusted GMT ratio: 0.91 (95% CI 0.8 to 1.04)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Nimenrix-B Group only.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimenrix-A Group	0 of 390 (0%)	274 of 390 (70.3%)	0 of 390
Nimenrix-B Group	1 of 390 (0.3%)	271 of 390 (69.5%)	0 of 390
Mencevax Group	0 of 390 (0%)	237 of 390 (60.8%)	0 of 390

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23885033Lupisan S, Limkittikul K, Sosa N, Chanthavanich P, Bianco V, Baine Y, Van der Wielen M, Miller JM. Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years. Clin Vaccine Immunol. 2013 Oct;20(10):1499-507. doi: 10.1128/CVI.00162-13. Epub 2013 Jul 24.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Infections, Meningococcal

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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.

GSK Clinical Trials study director

GlaxoSmithKline

3 sites in 3 countries: 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 10 inclusion and 21 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 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Panama, Philippines, Thailand. 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 26 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies (time frame: At Month 1). 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 NCT01154088, 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 26 Nov 2018.