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

Primary Purpose

Infections, Meningococcal

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Meningococcal vaccine 134612

Mencevax™ ACWY

About this trial

This is an interventional prevention trial for Infections, Meningococcal focused on measuring Immunogenicity, Meningococcal vaccine, Conjugate vaccine, Persistence

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Subjects previously primed with meningococcal vaccine 134612.

Subjects previously primed with Mencevax™ ACWY.

Outcomes

Primary Outcome Measures

Meningococcal rSBA titres.

Anti-meningococcal polysaccharide concentrations

Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.

Secondary Outcome Measures

Full Information

NCT ID

NCT00390143

First Posted

October 17, 2006

Last Updated

October 21, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00390143

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Meningococcal

Keywords

Immunogenicity, Meningococcal vaccine, Conjugate vaccine, Persistence

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Subjects previously primed with meningococcal vaccine 134612.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Subjects previously primed with Mencevax™ ACWY.

Intervention Type

Biological

Intervention Name(s)

Meningococcal vaccine 134612

Intervention Description

One intramuscular dose during the primary study

Intervention Type

Biological

Intervention Name(s)

Mencevax™ ACWY

Intervention Description

One subcutaneous dose during the primary study

Primary Outcome Measure Information:

Title

Meningococcal rSBA titres.

Time Frame

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

Title

Anti-meningococcal polysaccharide concentrations

Time Frame

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

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

23246368

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108595 Mth18

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108595 Mth18

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108595 Mth18

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108595 Mth18

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108595 Mth18

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108595 Mth18

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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