Clinical trial NCT01266993: Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children
Official title: Persistence of Antibodies After Vaccination With a Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children and Safety and Immunogenicity of a Booster Dose at 68 Months Post-primary Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Meningococcal Vaccines
Keywords: Immunogenicity
Persistence
Safety
Conjugate vaccine
Meningococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 271
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®.

This protocol posting deals with objectives \& outcome measures of the persistence and booster epochs. The objectives \& outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)

Detailed description: Subjects were previously vaccinated at 2 to 10 years of age with GSK134612 or with Menjugate®. The persistence phase starts 32 months after the primary vaccination and blood samples will be taken at 32, 44, 56 and 68 months after primary vaccination. All subjects will receive a booster dose of GSK134612 at 68 months after primary vaccination and a blood sample will be taken 1 month after administration of the booster dose.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study (NCT number = NCT00674583).
* Written informed consent obtained from the parent(s)/Legally Acceptable Representatives(s) of the subject and written informed assent obtained from the subject (at investigator discretion).
* Healthy subjects as established by medical history and clinical examination before entering into the study.

All subjects must meet the additional following criteria prior to receiving the booster vaccination:

* Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study.
* 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 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product within 30 days preceding the first persistence blood sample or planned use within 30 days preceding a blood sample during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, prednisone \<10 mg/day, or equivalent, inhaled and topical steroids are allowed).
* Concurrently participating in another clinical study or planned participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product within 30 days of a blood sample.
* History of meningococcal disease.
* Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the previous vaccination in the primary vaccination study (NCT number = NCT00674583).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
* Serious chronic illness.
* Administration of immunoglobulins and/or blood products within the 3 months preceding the subject's first visit.
* Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
* Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
* Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred.

Exclusion criteria for booster vaccination to be checked at Visit 4 (Month 68)

* Child in care.
* Use of any investigational or non-registered product within 30 days preceding the booster vaccination 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 booster vaccination. (For corticosteroids, prednisone \<10 mg/day, or equivalent, inhaled and topical steroids are allowed).
* Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y since the previous vaccination in the primary vaccination study (NCT number = NCT00674583).
* History of 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 during the study period.
* Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, (from the time of the booster until the end of the study) 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.
* Hypersensitivity to latex.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within the last 30 days of the dose of vaccine(s) with the exception of a licensed inactivated influenza vaccine.
* Previous vaccination with tetanus toxoids within the last 30 days.
* A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Serious chronic illness.
* History of any neurological disorders or seizures (although subjects with a prior history of a single episode of benign febrile seizures may be allowed to participate in the study).
* Acute disease and/or fever at the time of vaccination.
* History of chronic alcohol consumption and/or drug abuse.
* History of hypotonic-hyporesponsive episodes (HHEs) following vaccination.
* Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
* Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred.
* Pregnant or lactating female.
* Female of child-bearing potential planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32.
timeFrame: At Month 32, post-primary vaccination
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44.
timeFrame: At Month 44, post-primary vaccination
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56.
timeFrame: At Month 56, post-primary vaccination
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68.
timeFrame: At Month 68, post-primary vaccination
Secondary outcomes:
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32.
timeFrame: At Month 32, post-primary vaccination
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44.
timeFrame: At Month 44, post-primary vaccination
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56.
timeFrame: At Month 56, post-primary vaccination
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68.
timeFrame: At Month 68, post-primary vaccination
measure: Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32.
timeFrame: At Month 32, post-primary vaccination
measure: Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44.
timeFrame: At Month 44, post-primary vaccination
measure: Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56.
timeFrame: At Month 56, post-primary vaccination
measure: Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68.
timeFrame: At Month 68, post-primary vaccination
measure: Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32.
timeFrame: At Month 32, post-primary vaccination
measure: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44.
timeFrame: At Month 44, post-primary vaccination
measure: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56.
timeFrame: At Month 56, post-primary vaccination
measure: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68.
timeFrame: At Month 68, post-primary vaccination
measure: Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32.
timeFrame: At Month 32, post-primary vaccination
measure: Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44.
timeFrame: At Month 44, post-primary vaccination
measure: Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56.
timeFrame: At Month 56, post-primary vaccination
measure: Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68.
timeFrame: At Month 68, post-primary vaccination
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8.
timeFrame: At Month 69, one month post-booster vaccination
measure: Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
timeFrame: At Month 69, one month post-booster vaccination
measure: Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8.
timeFrame: At Month 69, one month post-booster vaccination
measure: Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY
timeFrame: At Month 69, one month post-booster vaccination
measure: Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
timeFrame: At Month 69, one month post-booster vaccination
measure: Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
timeFrame: At Month 69, one month post-booster vaccination
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) period following the booster vaccination
measure: Number of Subjects With Any, Grade 3 and Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) period following the booster vaccination
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) period following the booster vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the 31-day (Days 0-30) period following the booster vaccination
measure: Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs)
timeFrame: During the 31-day (Days 0-30) period following the booster vaccination
measure: Number of Subjects With Serious Adverse Events SAEs
timeFrame: Up to Month 32, 44, 56 and 68
Other outcomes:
Locations:
city: Draguignan
country: France
facility: GSK Investigational Site
city: Le Havre
country: France
facility: GSK Investigational Site
city: Lingolsheim
country: France
facility: GSK Investigational Site
city: Miribel
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Saint Laurent du Var
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Heiligenhaus
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hille
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: