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

GlaxoSmithKline697 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

697

Conditions

Infections, Meningococcal

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

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

GSK Investigational Site

Goa, India

GSK Investigational Site

Indore, India

GSK Investigational Site

New Delhi, India

GSK Investigational Site

Pune, India

GSK Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: At Month 24 post primary dose

Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

Time frame: At Month 36 post primary dose

Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

Time frame: At Month 48 post primary dose

Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

Time frame: At Month 60 post primary dose

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups

A seropositive subject was defined as a subject who had the 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 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.

Time frame: At Months 24, 36, 48 and 60 post primary dose

Antibody Titers Against the Vaccine Meningococcal Serogroups

Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.

Time frame: At Months 24, 36, 48 and 60 post primary dose

Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides

Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).

Time frame: At Month 24 post primary dose

Antibody Concentrations Against the Vaccine Polysaccharides

Time frame: At Month 24 post primary dose