Infections, MeningococcalPhase 2NCT00715910
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
A Phase 2 study testing Nimenrix and Blood sampling in people with Infections, Meningococcal, run by GlaxoSmithKline at 10 sites in United States.
Trial summary
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with… Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Nimenrix and Blood sampling
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2008to Oct 2013
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Persistence phase:
- A male or female who was between and including 10 and 25 years of age at the time of primary vaccination in the study with NCT number = 00454909.
- Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history.
- Having completed the active phase of the vaccination study with NCT number = 00454909.
- Booster phase:
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- Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oophorectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.
- Additional inclusion criterion for the naïve control group:
- A male or female between, and including, 15 and 30 years of age at the time of the vaccination.
Who cannot join
- Persistence phase:
- Use of any investigational or non-registered product within 30 days of each persistence time point.
- Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
- History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding each persistence time point.
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- Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- Chronic alcohol or drug abuse.
- Subjects withdrew consent to be contacted for follow-up studies.
- Booster phase (to be checked at Year 5 for all subject, including naïve control group):
- Child in care
- Not enrolled in the Kaiser Healthcare system.
- Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior administration of the booster dose.
- Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
- History of any meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition,including human immunodeficiency virus infection based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination.
- 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.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- History of chronic alcohol consumption and/or drug abuse.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine.
- Previous vaccination with tetanus and diphtheria toxoids within the last month.
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Previous history of Guillain-Barré syndrome
- Acute disease at the time of vaccination.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination.
- For groups A, B and C only: Subjects withdrew consent to be contacted for follow-up studies.
- Note: if the subject is female, prior to vaccination she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Fairfield, California, 94533
GSK Investigational Site
Honolulu, Hawaii, 96814
GSK Investigational Site
Honolulu, Hawaii, 96819
GSK Investigational Site
Redwood City, California, 94063
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Vallejo, California, 94589
GSK Investigational Site
Waianae, Hawaii, 96792
GSK Investigational Site
Waipio, Hawaii, 96797
GSK Investigational Site
Walnut Creek, California, 94596
About this study
Official title: Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine Versus Menactra® in Healthy Adolescents/Adults Aged 10-25 Years and Booster Response to MenACWY-TT Vaccine Administered at 5 Years Post-primary Vaccination
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number =00454909) will be evaluated. The safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612 vaccine will also be evaluated.
Read the detailed description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in subjects as of 12 months of age.
The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® (meningococcal serogroups A, C, W-135 and Y-diphtheria toxoid conjugate vaccine, sanofi pasteur) when given to healthy adolescents/ adults 11 to 25 years of age In addition, the safety and immunogenicity of a booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary vaccination will be evaluated.
Another cohort of subjects (naïve control group) 15 to <31 years of age will be offered a dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve control group) and booster dose within the same study.
This Protocol Posting has been updated following Protocol Amendment 1, May 2010 and Protocol Amendment 2, May 2011.
- Conditions
- Infections, Meningococcal
- Being tested
- Nimenrix, Blood sampling
- Keywords
- Meningococcal vaccine, Booster vaccination, Immunogenicity, Meningococcal disease, 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.
NimenrixBiological
Also called Meningococcal vaccine GSK134612 (MenACWY-TT)
One dose, as intramuscular injection
Blood samplingProcedure or surgery
Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix 1 Group | Experimental | Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination Receives: Biological: Nimenrix; Procedure: Blood sampling |
| Menactra Group | Active comparator | Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination Receives: Biological: Nimenrix; Procedure: Blood sampling |
| Nimenrix 2 Group | Experimental | Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination Receives: Biological: Nimenrix; Procedure: Blood sampling |
| Nimenrix Naive Group | Experimental | Subjects 15 to <31 years of age at the time of primary vaccination with 1 dose of Nimenrix vaccine at year 5 of the current study Receives: Biological: Nimenrix; Procedure: Blood sampling |
| Nimenrix Pooled Group | Experimental | Pooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study. Receives: Biological: Nimenrix |
| Menactra Booster Group | Active comparator | Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study. Receives: Biological: Nimenrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Measured: At year 1 persistence
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Measured: At year 3 persistence
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Measured: At year 5 persistence
Secondary outcomes (19)
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Measured: At year 1 persistence
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Measured: At year 3 persistence
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Measured: At year 5 persistence
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Measured: At year 1 persistence
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Measured: At year 3 persistence
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Measured: At year 5 persistence
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.
Measured: At year 1 persistence
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.
Measured: At year 1 persistence
Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication
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.
Measured: From 6 months up to 1 year following primary vaccination
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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.
Measured: From 6 months up to 3 years following primary vaccination
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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.
Measured: From 6 months up to 5 years following primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.
Measured: 1 month post primary (naïve control group) and booster vaccination
hSBA Antibody Titers
Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Measured: 1 month post primary (naïve control group) and booster vaccination
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response was defined as:
For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination.
Measured: 1 month post primary (naïve control group) and booster vaccination
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
Measured: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Measured: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Number of Subjects With 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.
Measured: During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination
Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)
Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Measured: During the 6-month period following the primary (naïve control group) and booster vaccination
Number of Subjects With 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.
Measured: During the 6-month period following the primary (naïve control group) and booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2013
- Study completionOct 2013
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 (3)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
- 818 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
- NCT00715910
- Sponsor's protocol ID
- 111670
- Status last verified
- Sep 2014
- First submitted
- 11 Jul 2008
- Last updated
- 27 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
Baxter R et al. Antibody persistence and safety 3 years after a single dose of MenACWY-TT vaccine in healthy individuals aged 10-25 years. Abstract presented at the 31st Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Milan, Italy, 28 May-1 June 2013.
Baxter R, Baine Y, Kolhe D, Baccarini CI, Miller JM, Van der Wielen M. Five-year Antibody Persistence and Booster Response to a Single Dose of Meningococcal A, C, W and Y Tetanus Toxoid Conjugate Vaccine in Adolescents and Young Adults: An Open, Randomized Trial. Pediatr Infect Dis J. 2015 Nov;34(11):1236-43. doi: 10.1097/INF.0000000000000866.
PubMed 26237742
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine Versus Menactra® in Healthy Adolescents/Adults Aged 10-25 Years and Booster Response to MenACWY-TT Vaccine Administered at 5 Years Post-primary Vaccination
- ClinicalTrials.gov ID
- NCT00715910
- Acronym / sponsor ID
- 111670
- Conditions
- Infections, Meningococcal
- Keywords
- Meningococcal vaccine, Booster vaccination, Immunogenicity, Meningococcal disease, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 29 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number =00454909) will be evaluated. The safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612 vaccine will also be evaluated.
Detailed description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in subjects as of 12 months of age.
The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® (meningococcal serogroups A, C, W-135 and Y-diphtheria toxoid conjugate vaccine, sanofi pasteur) when given to healthy adolescents/ adults 11 to 25 years of age In addition, the safety and immunogenicity of a booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary vaccination will be evaluated.
Another cohort of subjects (naïve control group) 15 to <31 years of age will be offered a dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve control group) and booster dose within the same study.
This Protocol Posting has been updated following Protocol Amendment 1, May 2010 and Protocol Amendment 2, May 2011.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Nimenrix 1 Group | Experimental | Biological: Nimenrix, Procedure: Blood samplingSubjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination |
| Menactra Group | Active comparator | Biological: Nimenrix, Procedure: Blood samplingSubjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination |
| Nimenrix 2 Group | Experimental | Biological: Nimenrix, Procedure: Blood samplingSubjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination |
| Nimenrix Naive Group | Experimental | Biological: Nimenrix, Procedure: Blood samplingSubjects 15 to <31 years of age at the time of primary vaccination with 1 dose of Nimenrix vaccine at year 5 of the current study |
| Nimenrix Pooled Group | Experimental | Biological: NimenrixPooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study. |
| Menactra Booster Group | Active comparator | Biological: NimenrixSubjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- A male or female who was between and including 10 and 25 years of age at the time of primary vaccination in the study with NCT number = 00454909.
- Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history.
- Having completed the active phase of the vaccination study with NCT number = 00454909.
- Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
Key exclusion criteria (34 listed)
- Use of any investigational or non-registered product within 30 days of each persistence time point.
- Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
- History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding each persistence time point.
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 |
|---|---|---|
| NimenrixAlso: Meningococcal vaccine GSK134612 (MenACWY-TT)One dose, as intramuscular injection | Biological | Menactra Booster Group, Menactra Group, Nimenrix 1 Group, Nimenrix 2 Group, Nimenrix Naive Group, Nimenrix Pooled Group |
| Blood samplingBlood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61). | Procedure or surgery | Menactra Group, Nimenrix 1 Group, Nimenrix 2 Group, Nimenrix Naive Group |
Primary outcome
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
Time frame: At year 1 persistence
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Time frame: At year 3 persistence
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Time frame: At year 5 persistence
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
19 secondary outcomes
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Time frame: At year 1 persistence
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Time frame: At year 3 persistence
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
Time frame: At year 5 persistence
hSBA Antibody Titers
Time frame: At year 1 persistence
hSBA Antibody Titers
Time frame: At year 3 persistence
hSBA Antibody Titers
Time frame: At year 5 persistence
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
Time frame: At year 1 persistence
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Time frame: At year 1 persistence
Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication
Time frame: From 6 months up to 1 year following primary vaccination
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
Time frame: From 6 months up to 3 years following primary vaccination
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
Time frame: From 6 months up to 5 years following primary vaccination
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
Time frame: 1 month post primary (naïve control group) and booster vaccination
hSBA Antibody Titers
Time frame: 1 month post primary (naïve control group) and booster vaccination
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Time frame: 1 month post primary (naïve control group) and booster vaccination
Number of Subjects With Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination
Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)
Time frame: During the 6-month period following the primary (naïve control group) and booster vaccination
Number of Subjects With SAEs
Time frame: During the 6-month period following the primary (naïve control group) and booster vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBaxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
- BackgroundBaxter R et al. Antibody persistence and safety 3 years after a single dose of MenACWY-TT vaccine in healthy individuals aged 10-25 years. Abstract presented at the 31st Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Milan, Italy, 28 May-1 June 2013.
- Derived from this study: PubMed 26237742Baxter R, Baine Y, Kolhe D, Baccarini CI, Miller JM, Van der Wielen M. Five-year Antibody Persistence and Booster Response to a Single Dose of Meningococcal A, C, W and Y Tetanus Toxoid Conjugate Vaccine in Adolescents and Young Adults: An Open, Randomized Trial. Pediatr Infect Dis J. 2015 Nov;34(11):1236-43. doi: 10.1097/INF.0000000000000866.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimenrix and Blood sampling in people with Infections, Meningococcal, run by GlaxoSmithKline at 10 sites in United States.
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 34 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 27 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 29 May 2014). 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 Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values (time frame: At year 1 persistence). The study lists 3 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 NCT00715910, which also lists 3 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 27 Nov 2014.