Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-23

Study Completion Date

2008-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives \& outcome measures of both the primary \& extension phases.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age

NCT03652610

Infections, Meningococcal

COMPLETED PHASE2

Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

NCT01934140

Infections, Meningococcal

COMPLETED PHASE3

A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age

NCT03433482

Meningitis, Meningococcal

COMPLETED PHASE2

Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine

NCT00126984

Infections, Meningococcal

COMPLETED PHASE2

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

NCT01235975

Infections, Meningococcal

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections, Meningococcal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nimenrix Group

Subjects receiving GSK Biologicals' meningococcal vaccine 134612

Group Type EXPERIMENTAL

meningococcal ACWY (vaccine)

Intervention Type BIOLOGICAL

One intramuscular dose.

Mencevax Group

Subjects receiving Mencevax™ ACWY

Group Type ACTIVE_COMPARATOR

Mencevax™ ACWY

Intervention Type BIOLOGICAL

One subcutaneous dose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

meningococcal ACWY (vaccine)

One intramuscular dose.

Intervention Type BIOLOGICAL

Mencevax™ ACWY

One subcutaneous dose.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol.
* A male or female between, and including, 11 and 55 years of age at the time of vaccination.
* Written informed consent obtained from the subject/ from the parent or legally acceptable representative of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Previously completed routine childhood vaccinations to the best of his/her knowledge and/or his/her parents/legally acceptable representative's knowledge.
* If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test.

Exclusion Criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
* Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y within the last five previous years.
* Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y.
* History of meningococcal disease due to serogroup A, C, W or Y.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* History of Guillain-Barré syndrome.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Specific criteria to be checked at each study visit for the long term follow-up:

* History of meningococcal serogroup A,C, W and Y disease.
* Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.

Minimum Eligible Age

11 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

City of Muntinlupa, , Philippines

Site Status

GSK Investigational Site

Manila, , Philippines

Site Status

GSK Investigational Site

Riyadh, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Philippines Saudi Arabia

References

Explore related publications, articles, or registry entries linked to this study.

Borja-Tabora CF, Montalban C, Memish ZA, Boutriau D, Kolhe D, Miller JM, Van der Wielen M. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015 Oct 6;15:409. doi: 10.1186/s12879-015-1138-y.

Reference Type DERIVED

PMID: 26437712 (View on PubMed)

Borja-Tabora C, Montalban C, Memish ZA, Van der Wielen M, Bianco V, Boutriau D, Miller J. Immune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled study. BMC Infect Dis. 2013 Mar 5;13:116. doi: 10.1186/1471-2334-13-116.

Reference Type DERIVED

PMID: 23510357 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.