Last updated: 11/07/2018 01:58:16
Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Study in adolescents/adults to evaluate non-inferiority&persistence up to 5 years of GSK Bio MenACWY conjugate vaccine

GSK study ID
107386
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority & Persistence of the Immune Response of GSK Biologicals' MenACWY Conjugate Vaccine (Intramuscularly) vs Mencevax ACWY (Subcutaneously) to Healthy Subjects (11-55 Years of Age)
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Vaccine response to meningococcal antigens for serum bactericidal assay using rabbit complement (rSBA)

Timeframe: One month post vaccination

Occurrence of any grade 3 systemic symptoms

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

Secondary outcomes:

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

Timeframe: Prior to and 1 Month after vaccination

rSBA antibody titers

Timeframe: Prior to and 1 Month after vaccination

Number of subjects with anti-Polysaccharide (anti-PS) antibodies

Timeframe: Prior to and 1 Month after vaccination

Concentration of anti-PS antibodies

Timeframe: Prior to and 1 Month after vaccination

Number of subjects with anti-Tetanus (anti-TT) antibodies

Timeframe: Prior to and 1 Month after vaccination

Concentration of anti-TT antibodies

Timeframe: Prior to and 1 Month after vaccination

Number of subjects with rSBA antibody titers ≥ the cut-off value

Timeframe: At Year 1

rSBA antibody titers

Timeframe: At Year 1

Number of subjects with rSBA antibody titers ≥ the cut-off value

Timeframe: At Year 2

rSBA antibody titers

Timeframe: At Year 2

Number of subjects with rSBA antibody titers ≥ the cut-off value

Timeframe: At Year 3

rSBA antibody titers

Timeframe: At Year 3

Number of subjects with rSBA antibody titers ≥ the cut-off value

Timeframe: At Year 4

rSBA antibody titers

Timeframe: At Year 4

Number of subjects with rSBA antibody titers ≥ the cut-off value

Timeframe: At Year 5

rSBA antibody titers

Timeframe: At Year 5

Number of subjects with anti-PS antibodies

Timeframe: At Year 1

Concentration of anti-PS antibodies

Timeframe: At Year 1

Number of subjects with anti-PS antibodies

Timeframe: At Year 2

Concentration of anti-PS antibodies

Timeframe: At Year 2

Number of subjects with anti-PS antibodies

Timeframe: At Year 3

Concentration of anti-PS antibodies

Timeframe: At Year 3

Number of subjects with any and Grade 3 solicited local symptoms

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

Number of subjects with any, Grade 3 and related solicited general symptoms

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

Number of subjects with New Onset of Chronic Illnesses (NOCIs)

Timeframe: From Day 0 up to 6 Months after vaccination

Number of subjects with rash

Timeframe: From Day 0 up to 6 Months after vaccination

Number of subjects with AEs resulting in emergency rooms visits

Timeframe: From Day 0 up to 6 Months after vaccination

Number of subjects with unsolicited AEs

Timeframe: Up to 31 Days after vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: From Day 0 up to 6 Months after vaccination

Number of subjects with SAEs

Timeframe: At Year 1, Year 2, Year 3, Year 4 and Year 5

Interventions:
  • Biological/vaccine: meningococcal ACWY (vaccine)
  • Biological/vaccine: Mencevax™ ACWY
  • Enrollment:
    500
    Primary completion date:
    2007-07-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Borja-Tabora C et al. (2013) 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. 13(116).
    Borja-Tabora C et al. (2015) 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. 15:409.
    Medical condition
    Infections, Meningococcal
    Product
    GSK134612A, SB208144
    Collaborators
    Not applicable
    Study date(s)
    December 2006 to February 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 55 years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Riyadh, Saudi Arabia
    Status
    Study Complete
    Location
    GSK Investigational Site
    Muntinlupa, Philippines, 1781
    Status
    Study Complete
    Location
    GSK Investigational Site
    Manila, Philippines, 1000
    Status
    Study Complete

    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2007-07-09
    Actual study completion date
    2008-28-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website