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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Meningococcal

Treatments

Procedure: Blood Sampling

Study type

Interventional

Funder types

Industry

Identifiers

NCT00974363

112148

Details and patient eligibility

About

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.

Full 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.

Enrollment

697 patients

Sex

All

Ages

11 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.