Last updated: 11/03/2018 10:13:52
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 GSK’s Clinical Study Register is no longer maintained for this study.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

Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults

GSK study ID
109067
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: Lot-to-Lot Consistency, Non-Inferiority Versus Mencevax™ and Evaluation of the co-Administration With Fluarix™ of GSK Biologicals' Meningococcal Vaccine GSK134612, in Healthy Subjects Aged 18 Through 55 Years of Age
Trial description: The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Serum bactericidal assay (performed using baby rabbit complement) for Neisseria meningitidis serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibody titers, in each of the 3 lot groups.

Timeframe: One month after vaccination (at Month 1)

Number of subjects with a vaccine response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: One month after vaccination (at Month 1)

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers, in subjects receiving the Nimenrix Lot A + Fluarix vaccines or the Nimenrix vaccine (pooled lots in the Flu vaccine cohort)

Timeframe: One month after vaccination (at Month 1)

Serum haemagglutination inhibition (HI) antibody titers against each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Number of seroconverted subjects for HI antibody titers for each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.

Timeframe: One month after vaccination (at Month 1)

Seroconversion factor for HI antibody titers for each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.

Timeframe: One month after vaccination (at Month 1)

Number of seroprotected subjects HI antibody titers for each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1)

Secondary outcomes:

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers equal to or above the cut-off values, in each of the 3 lot groups.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers, in each of the 3 lot groups.

Timeframe: Prior to vaccination (at Month 0).

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers equal to or above the cut-off values, for subjects in the Flu vaccine cohort

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers, for subjects in the Flu vaccine cohort

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers equal to or above the cut-off values, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Number of subjects with a vaccine response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody, for subjects in the Flu vaccine cohort

Timeframe: One month after vaccination (at Month 1)

Number of subjects with anti-tetanus antibody concentrations equal to or above the cut-off value of 0.1 International unit per milliliter (IU/mL), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Anti-tetanus antibody concentrations, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Number of subjects with anti-tetanus antibody concentrations equal to or above the cut-off value of 0.1 International unit per milliliter (IU/mL), for subjects in the Flu vaccine cohort

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Anti-tetanus antibody concentrations for subjects in the Flu vaccine cohort

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Number of subjects with anti-meningococcal polysaccharide serogroups, A, C, W-135 and Y antibody concentrations equal to or above the cut-off values, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Anti-PSA, anti-PSC, anti-PSW-135 & anti-PSY antibody concentrations, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 & anti-PSY antibody concentrations equal to or above the cut-off values, for subjects in the Flu vaccine cohort

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Anti-PSA, anti-PSC, anti-PSW-135 & anti-PSY antibody concentrations, for subjects in the Flu vaccine cohort

Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).

Number of subjects with any and severe solicited local symptoms, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination

Number of subjects with any and severe solicited local symptoms, for subjects in the Flu vaccine cohort receiving the Nimenrix or the Mencevax ACWY vaccines.

Timeframe: During the 4-day (Days 0-3) follow-up period after meningococcal vaccination

Number of subjects with any and severe solicited local symptoms, in subjects receiving the Fluarix vaccine

Timeframe: During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration

Number of subjects with any and severe solicited general symptoms, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination

Number of subjects with any and severe solicited general symptoms, for subjects in the Flu vaccine cohort

Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination

Number of subjects reporting rash, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Number of subjects reporting new onset of chronic illness(es) (NOCIs), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Number of subjects reporting adverse events (AEs) resulting in emergency room (ER) visits, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Number of subjects reporting rash, for subjects in the Flu vaccine cohort

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Number of subjects reporting new onset of chronic illness(es) (NOCIs), for subjects in the Flu vaccine cohort

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Number of subjects reporting adverse events (AEs) resulting in emergency room (ER) visits, for subjects in the Flu vaccine cohort

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Number of subjects reporting unsolicited adverse events (AEs), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)

Number of subjects reporting serious adverse events (SAEs), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Number of subjects reporting unsolicited adverse events (AEs), for subjects in the Flu vaccine cohort

Timeframe: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)

Number of subjects reporting serious adverse events (SAEs), for subjects in the Flu vaccine cohort

Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)

Interventions:
  • Biological/vaccine: Meningococcal vaccine GSK134612
  • Biological/vaccine: Mencevax™ACWY
  • Biological/vaccine: Fluarix™
  • Enrollment:
    1352
    Primary completion date:
    2007-30-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Dbaibo G et al. (2012) The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine: a randomized, controlled non-inferiority study. Hum Vaccin Immunother. 8(7):873-880.
    Macalalad N et al. The candidate Meningococcal serogroups A, C, W-135, Y conjugate vaccine (MenACWY-TT) and the seasonal influenza virus vaccine are immunogenic with an acceptable safety profile when co-administered in adults. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM) Hamburg, Germany, May 26-29, 2010.
    Reyes MR et al (2012) The investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults. Hum Vaccin Immunother. 8(7):881-887.
    Medical condition
    Infections, Meningococcal
    Product
    GSK134612A, SB208144, SB218352
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to May 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • For all subjects:
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
    • For all subjects:
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cavite, Philippines, 4114
    Status
    Study Complete
    Location
    GSK Investigational Site
    Manila, Philippines
    Status
    Study Complete
    Location
    GSK Investigational Site
    Muntinlupa, Philippines
    Status
    Study Complete
    Location
    GSK Investigational Site
    Beirut, Lebanon, 1107-2020
    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
    2007-30-11
    Actual study completion date
    2008-21-05

    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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