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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infections, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Subjects previously primed with meningococcal vaccine 134612.

Group Type EXPERIMENTAL

Meningococcal vaccine 134612

Intervention Type BIOLOGICAL

One intramuscular dose during the primary study

Group B

Subjects previously primed with Mencevax™ ACWY.

Group Type ACTIVE_COMPARATOR

Mencevax™ ACWY

Intervention Type BIOLOGICAL

One subcutaneous dose during the primary study

Interventions

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Meningococcal vaccine 134612

One intramuscular dose during the primary study

Intervention Type BIOLOGICAL

Mencevax™ ACWY

One subcutaneous dose during the primary study

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aarhus N, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND

PMID: 23246368 (View on PubMed)

Study Documents

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