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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00390143

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 II

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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)

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. ]
Anti-meningococcal polysaccharide concentrations [ Time Frame: At the start of this persistence study and 12 and 24 months later. ]
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. ]

Estimated Enrollment:	50
Study Start Date:	February 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Subjects previously primed with meningococcal vaccine 134612.	Biological: Meningococcal vaccine 134612 One intramuscular dose during the primary study
Group B: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390143

Locations

Denmark
GSK Clinical Trials Call Center
Arhus, Denmark

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	108595 Mth18, 108596 Mth30, 108598 Mth 42
Study First Received:	October 17, 2006
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00390143 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by GlaxoSmithKline:

Meningococcal vaccine
Persistence
Immunogenicity
Conjugate vaccine

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009