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

NCT00390143 | Completed Phase 2

• 3 other identifiers: 108595 Mth18108596108598
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infections, Meningococcal

Keywords

Immunogenicity; Meningococcal vaccine; Conjugate vaccine; Persistence

Outcome Measures

Primary Outcomes (3)

• Meningococcal rSBA titres.

  At the start of this persistence study and 12 and 24 months later.

• Anti-meningococcal polysaccharide concentrations

  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.

  From the last study contact of the primary vaccination study to the end of this persistence study.

Study Arms (2)

Group A

EXPERIMENTAL

Subjects previously primed with meningococcal vaccine 134612.

Biological: Meningococcal vaccine 134612

Group B

ACTIVE COMPARATOR

Subjects previously primed with Mencevax™ ACWY.

Biological: Mencevax™ ACWY

Interventions

Meningococcal vaccine 134612 BIOLOGICAL

One intramuscular dose during the primary study

Group A

Mencevax™ ACWY BIOLOGICAL

One subcutaneous dose during the primary study

Group B

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Ostergaard L, Van der Wielen M, Bianco V, Miller JM. Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT). Int J Infect Dis. 2013 Mar;17(3):e173-6. doi: 10.1016/j.ijid.2012.10.001. Epub 2012 Dec 13.

  PMID: 23246368 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 19, 2006
• Study Start: February 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)