Last updated: 07/17/2024 15:14:15
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 GSK’s Clinical Study Register is no longer maintained for this study.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 Given as 1 or 2 Doses to Healthy 9-12 Months old Toddlers.

GSK study ID
109375
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 primary vaccination with GSK Biologicals' MenACWY vaccine (GSK134612) given as 1 or 2 doses to healthy toddlers 9-12 months of age
Trial description: The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
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: One month after the last dose (at Month 4)

Secondary outcomes:

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

Timeframe: One month after the first dose (at Month 1)

Number of subjects with serum bactericidal assay using 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 (for GSK 134612 2 doses Group only) and Month 4

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

Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4

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

Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4

Number of subjects with serum bactericidal assay using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to the cut-off value

Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4

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

Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4

Number of subjects with anti-polysaccharide meningococcal serogroup A (anti-PSA), serogroup C (anti-PSC), serogroup W-135 (anti-PSW-135) and serogroup Y (anti-PSY) antibody concentrations greater than or equal to the cut-off value

Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4

Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations greater than or equal to the cut-off value

Timeframe: At Month 1 (GSK 134612 s doses Group only) and Month 4

Anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination

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

Timeframe: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: Up to 1 month post-vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: Up to study end (Month 9)

Number of subjects with new onset chronic ilnesses (NOCI)

Timeframe: Up to study end (Month 9)

Number of subjects reporting rash

Timeframe: Up to study end (Month 9)

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

Timeframe: Up to study end (Month 9)

Interventions:
  • Biological/vaccine: Meningococcal vaccine GSK134612
  • Enrollment:
    385
    Primary completion date:
    2008-23-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Klein KP et al. (2013) One or two doses of quadrivalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine is immunogenic in 9-12 month old children. Pediatr Infect Dis J. [Epub ahead of print].
    Klein N et al. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal ACWY Tetanus Toxoid Conjugate Vaccine in Healthy Toddlers: 1-year Persistence. 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)
    July 2007 to November 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    9 - 9 months
    Accepts healthy volunteers
    Yes
    • Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
    • A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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
    Wheat Ridge, Colorado, United States, 80033
    Status
    Study Complete
    Location
    GSK Investigational Site
    Westminster, Colorado, United States, 80234
    Status
    Study Complete
    Location
    GSK Investigational Site
    Amarillo, Texas, United States, 79124
    Status
    Study Complete
    Location
    GSK Investigational Site
    Birmingham, Georgia, United States, 35244
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Fremont, California, United States, 94538
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lakewood, Colorado, United States, 80226
    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
    2008-23-10
    Actual study completion date
    2008-26-11

    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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