NCT00974363

Brief Summary

Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
697

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2009

Typical duration for phase_3

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

April 12, 2017

Completed
Last Updated

April 12, 2017

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

September 7, 2009

Results QC Date

December 12, 2016

Last Update Submit

March 1, 2017

Conditions

Infections, Meningococcal

Keywords

meningococcal vaccine GSK 134612

Outcome Measures

Primary Outcomes (4)

  • Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

    A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.

    At Month 24 post primary dose

  • Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

    A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.

    At Month 36 post primary dose

  • Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

    A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.

    At Month 48 post primary dose

  • Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

    A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.

    At Month 60 post primary dose

Secondary Outcomes (4)

  • Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups

    At Months 24, 36, 48 and 60 post primary dose

  • Antibody Titers Against the Vaccine Meningococcal Serogroups

    At Months 24, 36, 48 and 60 post primary dose

  • Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides

    At Month 24 post primary dose

  • Antibody Concentrations Against the Vaccine Polysaccharides

    At Month 24 post primary dose

Study Arms (2)

Group A

EXPERIMENTAL

Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.

Procedure: Blood Sampling

Group B

ACTIVE COMPARATOR

Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.

Procedure: Blood Sampling

Interventions

Blood SamplingPROCEDURE

A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study

Group AGroup B

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
  • Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
  • History of meningococcal disease; such cases will be documented.
  • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
  • Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
  • Subjects who withdrew consent to be contacted for follow-up studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Goa, 403202, India

Location

GSK Investigational Site

Indore, 452001, India

Location

GSK Investigational Site

New Delhi, 110002, India

Location

GSK Investigational Site

Pune, 411 011, India

Location

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

None reported.

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2009

First Posted

September 10, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 12, 2017

Results First Posted

April 12, 2017

Record last verified: 2016-12

Locations

IN(4)PH(1)