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Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00974363
First received: September 7, 2009
Last updated: February 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Meningococcal Serogroups A, C, W-135 and/or Y Disease
 Procedure: Blood Sampling
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Persistence of immunogenicity with respect to components of the investigational vaccine [ Time Frame: 24, 36, 48 and 60 months post primary dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistence of immunogenicity with respect to components of the investigational vaccine (on secondary readouts) [ Time Frame: 24, 36, 48 and 60 months post primary dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 690
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
 Procedure: Blood Sampling
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
Active Comparator: Group B
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
 Procedure: Blood Sampling
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

Detailed Description:

Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. 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 studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974363

Locations
India
GSK Investigational Site
Goa, India, 403202
GSK Investigational Site
Indore, India, 452001
GSK Investigational Site
New Delhi, India, 110002
GSK Investigational Site
Pune, India, 411 011
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00974363     History of Changes
Other Study ID Numbers: 112148
Study First Received: September 7, 2009
Last Updated: February 7, 2013
Health Authority: India: Drugs Controller General of India
Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
meningococcal vaccine GSK 134612

ClinicalTrials.gov processed this record on May 23, 2013