Clinical trial NCT00974363: Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Official title: Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: meningococcal vaccine GSK 134612
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-10
Enrollment: 697
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
timeFrame: At Month 24 post primary dose
measure: Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
timeFrame: At Month 36 post primary dose
measure: Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
timeFrame: At Month 48 post primary dose
measure: Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
timeFrame: At Month 60 post primary dose
Secondary outcomes:
measure: Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
timeFrame: At Months 24, 36, 48 and 60 post primary dose
measure: Antibody Titers Against the Vaccine Meningococcal Serogroups
timeFrame: At Months 24, 36, 48 and 60 post primary dose
measure: Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
timeFrame: At Month 24 post primary dose
measure: Antibody Concentrations Against the Vaccine Polysaccharides
timeFrame: At Month 24 post primary dose
Other outcomes:
Locations:
city: Goa
country: India
facility: GSK Investigational Site
city: Indore
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: