Infections, MeningococcalPhase 2NCT00356369
Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
A Phase 2 study testing meningococcal ACWY (vaccine) and Mencevax™ ACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. Read more about this study
- Who is it for?
- Ages 11 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- meningococcal ACWY (vaccine) and Mencevax™ ACWY
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Dec 2006to 28 Feb 2008
- Phase
- Phase 2
- 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 11 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol.
- A male or female between, and including, 11 and 55 years of age at the time of vaccination.
- Written informed consent obtained from the subject/ from the parent or legally acceptable representative of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her knowledge and/or his/her parents/legally acceptable representative's knowledge.
- If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y within the last five previous years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y.
- History of meningococcal disease due to serogroup A, C, W or Y.
Show all 20Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- History of Guillain-Barré syndrome.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first 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.
- Specific criteria to be checked at each study visit for the long term follow-up:
- History of meningococcal serogroup A,C, W and Y disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Philippines2 sites
GSK Investigational Site
City of Muntinlupa, 1781
GSK Investigational Site
Manila, 1000
About this study
Official title: Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives \& outcome measures of both the primary \& extension phases.
Read the detailed description
All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
- Conditions
- Infections, Meningococcal
- Being tested
- meningococcal ACWY (vaccine), Mencevax™ ACWY
- Keywords
- Immunogenicity, Healthy, Persistence, Meningococcal vaccine, Non-inferiority, Meningococcal A C W Y Diseases, meningococcal serogroups A, C, W & Y diseases
- 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 ACWY (vaccine)Biological
One intramuscular dose.
Mencevax™ ACWYBiological
One subcutaneous dose.
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix Group | Experimental | Subjects receiving GSK Biologicals' meningococcal vaccine 134612 Receives: Biological: meningococcal ACWY (vaccine) |
| Mencevax Group | Active comparator | Subjects receiving Mencevax™ ACWY Receives: Biological: Mencevax™ ACWY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Measured: One month post vaccination
Occurrence of Any Grade 3 Systemic Symptoms
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm).
General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C.
Measured: During the 4-day (Days 0-3) post-vaccination period
Secondary outcomes (30)
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (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 and (≥) 1:128.
Measured: Prior to and 1 Month after vaccination
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Measured: Prior to and 1 Month after vaccination
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Measured: Prior to and 1 Month after vaccination
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).
Measured: Prior to and 1 Month after vaccination
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Measured: Prior to and 1 Month after vaccination
Concentration of Anti-TT Antibodies
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Measured: Prior to and 1 Month after vaccination
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: At Year 1
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Measured: At Year 1
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: At Year 2
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Measured: At Year 2
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: At Year 3
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Measured: At Year 3
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: At Year 4
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Measured: At Year 4
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: At Year 5
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Measured: At Year 5
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Measured: At Year 1
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Measured: At Year 1
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Measured: At Year 2
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Measured: At Year 2
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Measured: At Year 3
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Measured: At Year 3
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: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 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
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From Day 0 up to 6 Months after vaccination
Number of Subjects With Rash
Measured: From Day 0 up to 6 Months after vaccination
Number of Subjects With AEs Resulting in Emergency Rooms Visits
Measured: From Day 0 up to 6 Months after vaccination
Number of Subjects With Unsolicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: Up to 31 Days after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
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 Day 0 up to 6 Months after vaccination
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: At Year 1, Year 2, Year 3, Year 4 and Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study start23 Dec 2006
- Primary completion7 Sep 2007
- Study completion28 Feb 2008
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 (2)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT00356369
- Sponsor's protocol ID
- 107386
- Other IDs
- 107392 (Ext: Y1), 107398 (Ext: Y2), 107402 (Ext: Y3), 107404 (Ext: Y4), 107406 (Ext: Y5)
- Status last verified
- May 2018
- First submitted
- 25 Jul 2006
- Last updated
- 3 Jul 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
Borja-Tabora CF, Montalban C, Memish ZA, Boutriau D, Kolhe D, Miller JM, Van der Wielen M. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015 Oct 6;15:409. doi: 10.1186/s12879-015-1138-y.
PubMed 26437712Borja-Tabora C, Montalban C, Memish ZA, Van der Wielen M, Bianco V, Boutriau D, Miller J. Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study. BMC Infect Dis. 2013 Mar 5;13:116. doi: 10.1186/1471-2334-13-116.
PubMed 23510357
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)
- ClinicalTrials.gov ID
- NCT00356369
- Acronym / sponsor ID
- 107386
- Conditions
- Infections, Meningococcal
- Keywords
- Immunogenicity, Healthy, Persistence, Meningococcal vaccine, Non-inferiority, Meningococcal A C W Y Diseases, meningococcal serogroups A, C, W & Y diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2006 (actual)
- Primary completion
- 7 Sep 2007 (actual)
- Study completion
- 28 Feb 2008 (actual)
- First posted
- 26 Jul 2006 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives \& outcome measures of both the primary \& extension phases.
Detailed description
All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimenrix Group | Experimental | Biological: meningococcal ACWY (vaccine)Subjects receiving GSK Biologicals' meningococcal vaccine 134612 |
| Mencevax Group | Active comparator | Biological: Mencevax™ ACWYSubjects receiving Mencevax™ ACWY |
Who may qualify
- Ages
- 11 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol.
- A male or female between, and including, 11 and 55 years of age at the time of vaccination.
- Written informed consent obtained from the subject/ from the parent or legally acceptable representative of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her knowledge and/or his/her parents/legally acceptable representative's knowledge.
Key exclusion criteria (20 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y within the last five previous years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y.
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 ACWY (vaccine)One intramuscular dose. | Biological | Nimenrix Group |
| Mencevax™ ACWYOne subcutaneous dose. | Biological | Mencevax Group |
Primary outcome
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Time frame: One month post vaccination
Response to vaccine antigen was defined as: for initially seronegative subjects [subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Occurrence of Any Grade 3 Systemic Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) >39.5 °C.
30 secondary outcomes
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value
Time frame: Prior to and 1 Month after vaccination
rSBA Antibody Titers
Time frame: Prior to and 1 Month after vaccination
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies
Time frame: Prior to and 1 Month after vaccination
Concentration of Anti-PS Antibodies
Time frame: Prior to and 1 Month after vaccination
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies
Time frame: Prior to and 1 Month after vaccination
Concentration of Anti-TT Antibodies
Time frame: Prior to and 1 Month after vaccination
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Time frame: At Year 1
rSBA Antibody Titers
Time frame: At Year 1
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Time frame: At Year 2
rSBA Antibody Titers
Time frame: At Year 2
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Time frame: At Year 3
rSBA Antibody Titers
Time frame: At Year 3
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Time frame: At Year 4
rSBA Antibody Titers
Time frame: At Year 4
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Time frame: At Year 5
rSBA Antibody Titers
Time frame: At Year 5
Number of Subjects With Anti-PS Antibodies
Time frame: At Year 1
Concentration of Anti-PS Antibodies
Time frame: At Year 1
Number of Subjects With Anti-PS Antibodies
Time frame: At Year 2
Concentration of Anti-PS Antibodies
Time frame: At Year 2
Number of Subjects With Anti-PS Antibodies
Time frame: At Year 3
Concentration of Anti-PS Antibodies
Time frame: At Year 3
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Time frame: From Day 0 up to 6 Months after vaccination
Number of Subjects With Rash
Time frame: From Day 0 up to 6 Months after vaccination
Number of Subjects With AEs Resulting in Emergency Rooms Visits
Time frame: From Day 0 up to 6 Months after vaccination
Number of Subjects With Unsolicited AEs
Time frame: Up to 31 Days after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 up to 6 Months after vaccination
Number of Subjects With SAEs
Time frame: At Year 1, Year 2, Year 3, Year 4 and Year 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26437712Borja-Tabora CF, Montalban C, Memish ZA, Boutriau D, Kolhe D, Miller JM, Van der Wielen M. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015 Oct 6;15:409. doi: 10.1186/s12879-015-1138-y.
- Derived from this study: PubMed 23510357Borja-Tabora C, Montalban C, Memish ZA, Van der Wielen M, Bianco V, Boutriau D, Miller J. Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study. BMC Infect Dis. 2013 Mar 5;13:116. doi: 10.1186/1471-2334-13-116.
- 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.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing meningococcal ACWY (vaccine) and Mencevax™ ACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 3 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 6 inclusion and 20 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 3 Jul 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 Philippines, Saudi Arabia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Jun 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?
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) (time frame: One month post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356369, which also lists 2 linked publications.
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 3 Jul 2018.