The Vaccine Response and Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine (GSK134612) Administered as One Dose at 6 Years Post-MenC Primary Vaccination in Healthy Subjects Aged 12-18 Months at Primary Vaccination

GlaxoSmithKline1 site in 1 country156 target enrollmentMay 3, 2013

ConditionsInfections, Meningococcal

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Meningococcal
Sponsor: GlaxoSmithKline
Enrollment: 156
Locations: 1
Primary Endpoint: Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.

This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).

Registry

clinicaltrials.gov

Start Date

May 3, 2013

End Date

April 20, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
•A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
•Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
•Having completed the vaccination in the study \[Hib-MenC-TT-016 (106445)\] as per protocol.

Exclusion Criteria

•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
•Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the Hib-MenC-TT-016 study.
•History of meningococcal disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV)infection, based on medical history and physical examination (no laboratory testing required).
•Family history of congenital or hereditary immunodeficiency.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).

Outcomes

Primary Outcomes

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)

Time Frame: At Month 73, one month post-booster vaccination

Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.

Secondary Outcomes

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values(At Month 96, 24 months post-booster vaccination)
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY(At Month 73, one month post-booster vaccination)
Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values(At Month 73, one month post-booster vaccination)
Antibody Concentrations Against Tetanus (Anti-T) Antigen(At Month 73, one month post-booster vaccination)
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY(At Month 96, 24 months post-booster vaccination)
Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) post-booster vaccination period at Month 72)
Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) post-booster vaccination period at Month 72)
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)(During the 31-day (Days 0-30) post-booster vaccination period at Month 72)
Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-booster vaccination period at Month 72)
Number of Subjects With Serious Adverse Events (SAEs)(From Month 72 up to study end, at Month 96)