Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00674583
First received: May 7, 2008
Last updated: January 5, 2012
Last verified: March 2011
  Purpose

The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.


Condition Intervention Phase
Meningococcal Vaccines
Meningococcal Disease
Biological: GSK Biologicals' meningococcal vaccine GSK134612
Biological: Menjugate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Vaccine response to MenC [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Meningococcal rSBA titres [ Time Frame: Prior to and one month after vaccination ] [ Designated as safety issue: No ]
  • Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to and one month after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: Up to one month after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of SAEs [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of specific AEs of rash, new onset of chronic illness(es) and conditions prompting emergency room visits' [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 414
Study Start Date: May 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' meningococcal vaccine GSK134612
Intramuscular administration, 1 dose
Active Comparator: Group B Biological: Menjugate
Intramuscular administration, 1 dose
Other Name: MenC-CRM197vaccine

Detailed Description:

The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol.
  • A male or female between, and including, 2 and 10 years of age at the time of the vaccination.
  • Written informed consent obtained from the parent(s) 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.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose..
  • Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after.
  • Concurrently participating in another clinical study or planned participation 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.
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W-135 and/or Y (for subjects below 6 years) or within the last five years (for subjects 6 years old and above).
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • 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.
  • 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 study vaccine dose or planned administration during the study period.

Exclusion criteria for specified regions in France

  • Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135, or
  • Subjects living in a geographic area in France where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.
  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: NCT00674583

Locations
France
GSK Investigational Site
Draguignan, France, 83300
GSK Investigational Site
Laon, France, 02000
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
Vaulx en Velin, France, 69120
GSK Investigational Site
Vence, France, 06140
Germany
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
GSK Investigational Site
Muenchen, Bayern, Germany, 81735
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Espelkamp, Nordrhein-Westfalen, Germany, 32339
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
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
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, 14197
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 13055
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

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: NCT00674583     History of Changes
Other Study ID Numbers: 111414
Study First Received: May 7, 2008
Last Updated: January 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 31, 2014