Long Term Antibody Persistence Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Administered as 1 or 2 Doses to Healthy Toddlers at 9-12 Months of Age and as a Booster Dose at 5 Years Post-primary Vaccination

GlaxoSmithKline1 site in 1 country387 target enrollmentOctober 20, 2008

ConditionsInfections, Meningococcal

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Infections, Meningococcal
Sponsor: GlaxoSmithKline
Enrollment: 387
Locations: 1
Primary Endpoint: Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune response of a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination will also be evaluated. In addition, the immune response to a dose of vaccine GSK134612 administered to age-matched controls not previously given a meningococcal vaccine will be evaluated.

This protocol posting has been updated further to protocol amendment 2, dated 28 october 2010. The sections impacted are summary, study design, outcome measures, intervention, and eligibility criteria.

Detailed Description

GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers. The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one dose or two doses of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK134612 when given to healthy toddlers 9-12 months of age. To evaluate, the safety and immunogenicity of a booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary vaccination. To evaluate the safety and immunogenicity in a new group of subjects aged 5-6 years (naive control group) who will receive a single dose of vaccine GSK134612.

Registry

clinicaltrials.gov

Start Date

October 20, 2008

End Date

March 28, 2014

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects must satisfy the following criteria for the persistence phase of the study entry:
•A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=
•Written informed consent obtained from parents/guardian of the subject.
•Healthy subjects as established by medical history before entering into the study.
•Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose).
•All subjects must meet the following criteria prior to receiving the booster vaccination:
•Written informed consent obtained from parents/guardian of the subject.
•Subjects who can and will comply with the requirements of the protocol.
•Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=
•All subjects must satisfy the following criteria prior to enrollment in the naïve control group:

Exclusion Criteria

•Exclusion criteria for persistence study entry
•Use of any investigational or non-registered product (drug or vaccine) within 30 days of each persistence timepoint.
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=
•History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
•Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination (no laboratory testing is required).
•Administration of immunoglobulins and/or any blood products within the three months preceding each persistence timepoint.
•Concurrently participating in another clinical study within 30 days of each persistence timepoint, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Subjects withdrew consent to be contacted for follow-up studies.
•Exclusion criteria for primary (naive control)/booster vaccination at year 5 study entry (to be checked at Year 5)

Outcomes

Primary Outcomes

Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values

Time Frame: At Year 5 (60 months post primary vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.

Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off

Time Frame: At Year 3 (36 months post primnary vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.

Secondary Outcomes

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values(At Year 5 (60 months post primary vaccination))
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay(At Year 3 (36 months post primary vaccination))
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers(At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers(At Month 60 (pre-primary vaccination with Nimenrix vaccine))
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement(At Year 3 (36 months post primary vaccination))
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay(At Year 5 (60 months post-primary vacccination))
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values(At Month 60 (pre-primary vaccination with Nimenrix vaccine))
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers(At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)(During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers(At Year 5 (60 months post primary vaccination))
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay(At Year 5 (60 months post-primary vacccination).)
Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations(At Year 1 (12 months post primary vaccination))
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values(At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups))
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom(During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups)
rSBA Antibody Titers(At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups))
rSBA Antibody Titers.(At Year 5 (60 months following primary vaccination))
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values(At Year 1 (12 months post primary vaccination))
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values(At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)
Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers(At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups))
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom(During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups)
Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)(During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups)