Last updated: 11/03/2018 10:23:58
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 GSK’s Clinical Study Register is no longer maintained for this study.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

Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

GSK study ID
109377
Clinicaltrials.gov ID
EudraCT ID
Not applicable
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: Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.
Trial description: The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals’ meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The protocol posting has been updated following a protocol amendment.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Number of subjects with serum bactericidal assay using human complement against Neisseria meningitides serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) antibody titers greater than or equal to the cut-off value

Timeframe: At Day 0 (PRE)

Number of subjects with serum bactericidal assay using human complement against Neisseria meningitides serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) antibody titers greater than or equal to the cut-off value

Timeframe: At Month 1

Secondary outcomes:

Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y antibody titers greater than or equal to the cut-off value

Timeframe: At Day 0 (PRE) and Month 1

hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y antibody titers

Timeframe: At Day 0 (PRE) and Month 1

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

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

Timeframe: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0–30) follow-up period after vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: From Day 0 to Month 6

Number of subjects with new onset chronic illness(es) (NOCI)

Timeframe: From Day 0 to Month 6

Number of subjects reporting rash

Timeframe: From Day 0 to Month 6

Number of subjects reporting Adverse Events resulting in Emergency Room (ER) visits

Timeframe: From Day 0 to Month 6

Interventions:
  • Biological/vaccine: Meningococcal vaccine 134612
  • Biological/vaccine: Menactra®
  • Enrollment:
    873
    Primary completion date:
    2007-31-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Baxter R et al. (2011) Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Adolescents and Young Adults 10 to 25 Years of Age. Pediatric Infectious Disease Journal. 30(3):e41-e48.
    Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
    Medical condition
    Infections, Meningococcal
    Product
    GSK134612A
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to April 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    10 - 25 years
    Accepts healthy volunteers
    Yes
    • Subjects whom the investigator believes can and will comply with the requirements of the protocol.
    • A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the 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
    Waianae, Hawaii, United States, 96792
    Status
    Study Complete
    Location
    GSK Investigational Site
    Redwood City, California, United States, 94063
    Status
    Study Complete
    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94596
    Status
    Study Complete
    Location
    GSK Investigational Site
    Fairfield, California, United States, 94533
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sacramento, California, United States, 95815
    Status
    Study Complete
    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96819
    Status
    Study Complete
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    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
    2007-31-10
    Actual study completion date
    2008-11-04

    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

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