NCT00356369

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

December 23, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2008

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

June 4, 2018

Completed
Last Updated

July 3, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

July 25, 2006

Results QC Date

April 5, 2017

Last Update Submit

June 5, 2018

Conditions

Infections, Meningococcal

Keywords

ImmunogenicityHealthyPersistenceMeningococcal vaccineNon-inferiorityMeningococcal A C W Y Diseasesmeningococcal serogroups A, C, W & Y diseases

Outcome Measures

Primary Outcomes (2)

  • Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)

    Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.

    One month post vaccination

  • Occurrence of Any Grade 3 Systemic Symptoms

    Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \>39.5 °C.

    During the 4-day (Days 0-3) post-vaccination period

Secondary Outcomes (30)

  • Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value

    Prior to and 1 Month after vaccination

  • rSBA Antibody Titers

    Prior to and 1 Month after vaccination

  • Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies

    Prior to and 1 Month after vaccination

  • Concentration of Anti-PS Antibodies

    Prior to and 1 Month after vaccination

  • Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies

    Prior to and 1 Month after vaccination

  • +25 more secondary outcomes

Study Arms (2)

Nimenrix Group

EXPERIMENTAL

Subjects receiving GSK Biologicals' meningococcal vaccine 134612

Biological: meningococcal ACWY (vaccine)

Mencevax Group

ACTIVE COMPARATOR

Subjects receiving Mencevax™ ACWY

Biological: Mencevax™ ACWY

Interventions

meningococcal ACWY (vaccine)BIOLOGICAL

One intramuscular dose.

Nimenrix Group
Mencevax™ ACWYBIOLOGICAL

One subcutaneous dose.

Mencevax Group

Eligibility Criteria

Age11 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Riyadh, Saudi Arabia

Location

Related Publications (2)

  • 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.

    PMID: 26437712DERIVED

  • 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.

    PMID: 23510357DERIVED

Related Links

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Study Start

December 23, 2006

Primary Completion

September 7, 2007

Study Completion

February 28, 2008

Last Updated

July 3, 2018

Results First Posted

June 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Clinical Study Report (107386)Access
Individual Participant Data Set (107386)Access
Study Protocol (107386)Access
Informed Consent Form (107386)Access
Statistical Analysis Plan (107386)Access
Dataset Specification (107386)Access

Locations

PH(2)SA(1)