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

NCT ID: NCT00974363

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 697 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-05-31

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.

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.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Blood Sampling

Intervention Type: PROCEDURE

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 B

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

Group Type: ACTIVE_COMPARATOR

Blood Sampling

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Goa, , India

GSK Investigational Site

Indore, , India

GSK Investigational Site

New Delhi, , India

GSK Investigational Site

Pune, , India

GSK Investigational Site

City of Muntinlupa, , Philippines

Countries

India; Philippines

Other Identifiers

112148

Identifier Type: -

Identifier Source: org_study_id