Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00390143
First received: October 17, 2006
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives & outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.


Condition Intervention Phase
Meningococcal Serogroups A, C, W-135 and/or Y Disease
Biological: Meningococcal vaccine 134612
Biological: Mencevax™ ACWY
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assess Long Term Persistence of a Primary Dose of GSK Biologicals' Meningococcal Vaccine 134612 Versus One Dose of Mencevax™ ACWY in Healthy Adolescents/Young Adults (15 to 19 Years at Vaccination)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Meningococcal rSBA titres. [ Time Frame: At the start of this persistence study and 12 and 24 months later. ] [ Designated as safety issue: No ]
  • Anti-meningococcal polysaccharide concentrations [ Time Frame: At the start of this persistence study and 12 and 24 months later. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation. [ Time Frame: From the last study contact of the primary vaccination study to the end of this persistence study. ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: February 2007
Study Completion Date: May 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects previously primed with meningococcal vaccine 134612.
Biological: Meningococcal vaccine 134612
One intramuscular dose during the primary study
Active Comparator: Group B
Subjects previously primed with Mencevax™ ACWY.
Biological: Mencevax™ ACWY
One subcutaneous dose during the primary study

Detailed Description:

Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™ ACWY. This extension phase starts 18 months after vaccination and part of the subjects will be enrolled in this extension phase. No additional vaccines will be administered during this study and no new subjects will be enrolled. The subjects will have three blood samples taken: at 18, 30 and 42 months after vaccination.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study.
  • Written informed consent obtained from the subject/ from the parent or guardians of the subject.
  • Written informed assent obtained from the subject, as applicable, at the time of study entry.

Exclusion Criteria:

• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.

  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: NCT00390143

Locations
Denmark
GSK Investigational Site
Aarhus N, Denmark, 8200
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: NCT00390143     History of Changes
Other Study ID Numbers: 108595 Mth18, 108596, 108598
Study First Received: October 17, 2006
Last Updated: November 10, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by GlaxoSmithKline:
Immunogenicity
Meningococcal vaccine
Conjugate vaccine
Persistence

ClinicalTrials.gov processed this record on July 31, 2014