Clinical trial NCT00715910: The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Meningococcal
Keywords: Meningococcal vaccine
Booster vaccination
Immunogenicity
Meningococcal disease
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 818
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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:

* 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.

Exclusion Criteria:

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.
* 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.

Primary outcomes:
measure: Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
timeFrame: At year 1 persistence
measure: Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
timeFrame: At year 3 persistence
measure: Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
timeFrame: At year 5 persistence
Secondary outcomes:
measure: Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
timeFrame: At year 1 persistence
measure: Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
timeFrame: At year 3 persistence
measure: Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
timeFrame: At year 5 persistence
measure: hSBA Antibody Titers
timeFrame: At year 1 persistence
measure: hSBA Antibody Titers
timeFrame: At year 3 persistence
measure: hSBA Antibody Titers
timeFrame: At year 5 persistence
measure: 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
timeFrame: At year 1 persistence
measure: Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
timeFrame: At year 1 persistence
measure: Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication
timeFrame: From 6 months up to 1 year following primary vaccination
measure: Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
timeFrame: From 6 months up to 3 years following primary vaccination
measure: Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
timeFrame: From 6 months up to 5 years following primary vaccination
measure: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
timeFrame: 1 month post primary (naïve control group) and booster vaccination
measure: hSBA Antibody Titers
timeFrame: 1 month post primary (naïve control group) and booster vaccination
measure: Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
timeFrame: 1 month post primary (naïve control group) and booster vaccination
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination
measure: Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)
timeFrame: During the 6-month period following the primary (naïve control group) and booster vaccination
measure: Number of Subjects With SAEs
timeFrame: During the 6-month period following the primary (naïve control group) and booster vaccination
Other outcomes:
Locations:
city: Daly City
country: United States
facility: GSK Investigational Site
state: California
city: Fairfield
country: United States
facility: GSK Investigational Site
state: California
city: Redwood City
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Vallejo
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Waianae
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Waipio
country: United States
facility: GSK Investigational Site
state: Hawaii
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.