Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01266993
First received: December 16, 2010
Last updated: July 24, 2014
Last verified: June 2014
  Purpose

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)


Condition Intervention Phase
Infections, Meningococcal
Biological: Nimenrix (GSK134612 vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 32 [ Time Frame: 32 months after the primary vaccination ] [ Designated as safety issue: No ]
  • Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 44 [ Time Frame: 44 months after the primary vaccination ] [ Designated as safety issue: No ]
  • Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 56 [ Time Frame: 56 months after the primary vaccination ] [ Designated as safety issue: No ]
  • Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 68 [ Time Frame: 68 months after the primary vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistence of antibodies in all subjects with respect to components of the investigational vaccine (on secondary readouts) [ Time Frame: 32, 44, 56 and 68 months after the primary vaccination ] [ Designated as safety issue: No ]
  • Immunogenicity of booster vaccination in all subjects with respect to components of the investigational vaccine [ Time Frame: One month post-booster vaccination at Month 69 after primary vaccination ] [ Designated as safety issue: No ]
  • Occurrence of each solicited local symptom [ Time Frame: During the 4-day period following the booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of each solicited general symptom [ Time Frame: During the 4-day period following the booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day period (Days 0-30) following the booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the 31-day period following the booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of new onset of chronic illness (e.g. autoimmune disorders, asthma, type I diabetes and allergies) [ Time Frame: During the 31-day (Days 0-30) period following the booster vaccination ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: January 2011
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study will receive a booster dose of the same vaccine.
Biological: Nimenrix (GSK134612 vaccine)
Intramuscular, 1 dose
Experimental: Group B
Subjects who received Menjugate® in the primary study will receive a booster dose of Nimenrix (GSK134612 vaccine).
Biological: Nimenrix (GSK134612 vaccine)
Intramuscular, 1 dose

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

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266993

Locations
France
GSK Investigational Site
Draguignan, France, 83300
GSK Investigational Site
Le Havre, France, 76600
GSK Investigational Site
Lingolsheim, France, 67380
GSK Investigational Site
Miribel, France, 01700
GSK Investigational Site
Nice, France, 06300
GSK Investigational Site
Paris, France, 75015
GSK Investigational Site
Saint Laurent du Var, France, 06700
GSK Investigational Site
Tours, France, 37000
GSK Investigational Site
Vence, France, 06140
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
GSK Investigational Site
Solingen, Nordrhein-Westfalen, Germany, 42719
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Berlin, Germany, 10627
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 14197
GSK Investigational Site
Berlin, Germany, 10315
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01266993     History of Changes
Other Study ID Numbers: 113977
Study First Received: December 16, 2010
Last Updated: July 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Immunogenicity
Persistence
Safety
Conjugate vaccine
Meningococcal vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 31, 2014