Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00126984
First received: August 4, 2005
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.


Condition Intervention Phase
Meningitis, Meningococcal
Biological: Conjugated meningococcal ACWY-TT (vaccine)
Biological: DTPa/Hib containing vaccine
Biological: Meningitec
Biological: Mencevax ACWY
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open (Partially Double-blind), Randomized, Controlled Dose-range Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Investigational Vaccination Regimens Versus MENINGITEC™ or MENCEVAX™ ACWY When Given as One Dose to Children Aged 12 to 14 Months and 3 to 5 Years Old

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of meningococcal rSBA responders, in all subjects [ Time Frame: One month after the first vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Meningococcal rSBA titres [ Time Frame: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose ] [ Designated as safety issue: No ]
  • Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose ] [ Designated as safety issue: No ]
  • Anti-tetanus toxoid seropositivity and antibody concentrations [ Time Frame: Prior to and one month after administration of the first vaccine dose, in all subjects ] [ Designated as safety issue: No ]
  • Meningococcal hSBA titers [ Time Frame: Prior to & 1 month after the 1st dose and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose ] [ Designated as safety issue: No ]
  • Occurrence of local and general solicited adverse events [ Time Frame: During the 8-day follow-up period following the administration of each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day follow-up period following the administration of each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of any serious adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: July 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation A
Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa/Hib containing vaccine
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Experimental: Group B
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation B
Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa/Hib containing vaccine
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Experimental: Group C
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation C
Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa/Hib containing vaccine
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Biological: Mencevax ACWY
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)
Experimental: Group D
Subjects of 12-14 months of age or 3-5 years of age who will receive formulation D
Biological: Conjugated meningococcal ACWY-TT (vaccine)
One intramuscular dose during the primary vaccination
Biological: DTPa/Hib containing vaccine
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Active Comparator: Group E
Subjects of 12-14 months of age who will receive Meningitec and subjects of 3-5 years of age who will receive Mencevax ACWY.
Biological: DTPa/Hib containing vaccine
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Biological: Meningitec
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Biological: Mencevax ACWY
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)

Detailed Description:

The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. Meningitec™ or Mencevax™ ACWY vaccine will serve as active control. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.

  Eligibility

Ages Eligible for Study:   12 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
  • A male or female between, and including, 12 and 14 months or 3 and 5 years of age at the time of the first vaccination
  • Written informed consent obtained from the parent or guardian 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 parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine.
  • Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
  • Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
  • For subjects aged 12-14 months at enrolment, a DTPa/Hib containing booster vaccination, in the second year of life: these booster vaccines will be given at Visit 2.
  • History of meningococcal serogroup A, C, W-135 or Y disease.
  • Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
  • 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.
  • 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.
  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: NCT00126984

Locations
Austria
GSK Investigational Site
Guessing, Austria, A-7540
GSK Investigational Site
Neufeld/Leitha, Austria, A 2491
GSK Investigational Site
Salzburg, Austria, A-5020
GSK Investigational Site
Villach, Austria, A-9500
GSK Investigational Site
Wels, Austria, A-4600
Germany
GSK Investigational Site
Bietigheim/Bissingen, Baden-Wuerttemberg, Germany, 74321
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
GSK Investigational Site
Eppelheim, Baden-Wuerttemberg, Germany, 69214
GSK Investigational Site
Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68309
GSK Investigational Site
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Muenchen, Bayern, Germany, 80939
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Nuernberg, Bayern, Germany, 90473
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Tegernsee, Bayern, Germany, 83684
GSK Investigational Site
Tutzing, Bayern, Germany, 82327
GSK Investigational Site
Weilheim / Obb., Bayern, Germany, 82362
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67059
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
GSK Investigational Site
Dresden, Sachsen, Germany, 01169
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
GSK Investigational Site
Stollberg, Sachsen, Germany, 09366
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 14197
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Berlin, Germany, 12679
GSK Investigational Site
Berlin, Germany, 10967
GSK Investigational Site
Berlin, Germany, 13355
GSK Investigational Site
Berlin, Germany, 10315
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00126984     History of Changes
Other Study ID Numbers: 104703 (Primary study), 104704
Study First Received: August 4, 2005
Last Updated: January 5, 2012
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by GlaxoSmithKline:
Safety
Reactogenicity
Immunogenicity
Meningococcal vaccine
Dose selection
Conjugate vaccine

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on August 27, 2014