Infections, MeningococcalPhase 3NCT01641042
Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
A Phase 3 study testing Meningococcal vaccine GSK134612 in people with Infections, Meningococcal, run by GlaxoSmithKline at 16 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects. Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal vaccine GSK134612
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 10 Sep 2012to 3 Mar 2015
- 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 1 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- A male or female 1 to 17 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if
- the subject has practiced adequate contraception for one month (30 days) prior to the first vaccine dose, and
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- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception from administration of the first vaccine dose until 2 months after administration of the second vaccine dose.
- Additional inclusion criterion for At-risk group • Subjects with an increased risk for meningococcal disease, such as anatomic asplenia or some degree of functional asplenia or complement deficiencies.
- Additional inclusion criteria for Healthy group
- Healthy subject as established by medical history and clinical examination before entering into the study.
- Age-matched to a subject from the At-risk group according to age strata 1-5 years, 6-10 years and 11 to 17 years.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8).
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations.
- 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.
- History of meningococcal disease.
- Any confirmed or suspected Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
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- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine until one month after the second dose of study vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine including latex.
- Major congenital defects.
- History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
- Acute disease and/or fever at the time of enrolment.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Additional exclusion criteria for the At-risk group
- Vaccination against meningococcal disease of any serogroup
- within the last 3 years for subjects younger than 7 years.
- within the last 5 years for subjects 7 years and older.
- Additional exclusion criteria for the Healthy group
- Vaccination against meningococcal disease of any serogroup with polysaccharide or conjugate vaccine within the last 5 years.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- Family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- Serious chronic illness.
- History of asplenia or hyposplenia or complement deficiencies.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites
GSK Investigational Site
Antioch, California, 94509
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Durham, North Carolina, 27704
GSK Investigational Site
Durham, North Carolina, 27705
GSK Investigational Site
Fremont, California, 94538
GSK Investigational Site
Hayward, California, 94545
GSK Investigational Site
Oakland, California, 94611
GSK Investigational Site
Redwood City, California, 94063
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Santa Rosa, California, 95403
GSK Investigational Site
Vallejo, California, 94589
Czechia2 sites
GSK Investigational Site
Brno, 613 00
GSK Investigational Site
Hradec Králové, 500 02
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Administered to at Risk Subjects From 1 to Less Than 18 Years
The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.
Read the detailed description
For each at risk subject enrolled, an age-matched healthy subject will be enrolled. Age matching will be performed according to the following age strata: 1-5 years, 6-10 years, 11-17 years.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal vaccine GSK134612
- Keywords
- Meningococcal vaccines, Vaccines, conjugate, Neisseria meningitidis, Immunocompromised patient
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccine GSK134612Biological
2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Group | Experimental | The subjects in the Healthy group will be age-matched to the subjects in the At-risk group. Subjects will receive 2 doses of the investigational vaccine. Receives: Biological: Meningococcal vaccine GSK134612 |
| At-risk Group | Experimental | This group includes subjects with medical conditions placing them at an increased risk for meningococcal disease. Subjects will receive 2 doses of the investigational vaccine. Receives: Biological: Meningococcal vaccine GSK134612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies
Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects [i.e. pre-vaccination rSBA antibody titers below (<) 1:8] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Measured: One month after the first vaccine dose (at Month 1)
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies
Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
Measured: One month after the first vaccine dose (at Month 1)
Secondary outcomes (19)
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Measured: One month after the second vaccine dose (At Month 3)
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
Measured: One month after the second vaccine dose (At Month 3)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay was ≥ 1:8.
Measured: At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay was ≥ 1:128.
Measured: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens
Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.
Measured: At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay was ≥ 1:4.
Measured: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay ≥ 1:8.
Measured: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.
Measured: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values
The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).
Measured: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values
The cut-off value for the assay was ≥ 2.0 μg/mL.
Measured: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.
Measured: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years
Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Measured: From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
Measured: During the 31-day (Days 0-30) post first vaccination period
Number of Subjects Reporting Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
Measured: During the 31-day (Days 0-30) post second vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Month 0 until the end of the ESFU (at Month 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study start10 Sep 2012
- Primary completion10 Oct 2014
- Study completion3 Mar 2015
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641042
- Sponsor's protocol ID
- 115524
- Other IDs
- 2011-002410-36
- Status last verified
- Mar 2017
- First submitted
- 12 Jul 2012
- Last updated
- 18 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Administered to at Risk Subjects From 1 to Less Than 18 Years
- ClinicalTrials.gov ID
- NCT01641042
- Acronym / sponsor ID
- 115524
- Conditions
- Infections, Meningococcal
- Keywords
- Meningococcal vaccines, Vaccines, conjugate, Neisseria meningitidis, Immunocompromised patient
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2012
- Primary completion
- 10 Oct 2014 (actual)
- Study completion
- 3 Mar 2015 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 18 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.
Detailed description
For each at risk subject enrolled, an age-matched healthy subject will be enrolled. Age matching will be performed according to the following age strata: 1-5 years, 6-10 years, 11-17 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | Experimental | Biological: Meningococcal vaccine GSK134612The subjects in the Healthy group will be age-matched to the subjects in the At-risk group. Subjects will receive 2 doses of the investigational vaccine. |
| At-risk Group | Experimental | Biological: Meningococcal vaccine GSK134612This group includes subjects with medical conditions placing them at an increased risk for meningococcal disease. Subjects will receive 2 doses of the investigational vaccine. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- A male or female 1 to 17 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if
Key exclusion criteria (25 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8).
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations.
- 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.
- History of meningococcal disease.
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 |
|---|---|---|
| Meningococcal vaccine GSK1346122 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects. | Biological | At-risk Group, Healthy Group |
Primary outcome
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies
Time frame: One month after the first vaccine dose (at Month 1)
Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects [i.e. pre-vaccination rSBA antibody titers below (<) 1:8] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies
Time frame: One month after the first vaccine dose (at Month 1)
Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
19 secondary outcomes
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Time frame: One month after the second vaccine dose (At Month 3)
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Time frame: One month after the second vaccine dose (At Month 3)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
Time frame: At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
Time frame: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens
Time frame: At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Time frame: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
Time frame: From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post first vaccination period
Number of Subjects Reporting Any Unsolicited AEs
Time frame: During the 31-day (Days 0-30) post second vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 until the end of the ESFU (at Month 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- 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.
GSK Clinical Trials study director
GlaxoSmithKline
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal vaccine GSK134612 in people with Infections, Meningococcal, run by GlaxoSmithKline at 16 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 12 inclusion and 25 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Czechia. 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 18 Oct 2017). 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 a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies (time frame: One month after the first vaccine dose (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?
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 18 Oct 2017.