Last updated: 11/03/2018 08:32:13

US-licensed combined vaccine against tetanus & diphtheria, given with US-licensed vaccine against meningococcal disease

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GSK study ID
105753
See study documents
Clinicaltrials.gov ID
NCT00282295
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety & immunogenicity of a booster dose of dTPa vaccine (Boostrix®) co-admnd. with Aventis Pasteur’s meningococcal (serogroups A, C, Y and W-135) polysaccharide vaccine (Menactra™) vs admn. of either vaccine alone in healthy adolescents
Trial description: New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 – 18 years of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

Timeframe: At Month 1 (post Boostrix vaccination)

Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

Timeframe: At Month 1 (post Boostrix vaccination)

Number of subjects with booster responses for anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies

Timeframe: At Month 1 (post Boostrix vaccination)

Number of subjects with vaccine responses for serum bactericidal assay against Neisseria meningitidis serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)

Timeframe: One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)

Secondary outcomes:

Number of subjects with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibodies

Timeframe: At Day 0 (PRE) before Boostrix vaccination

Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

Timeframe: At Month 2 (one month post Boostrix vaccination)

Number of seroprotected subjects against diphteria (D) and tetanus (T) antigens

Timeframe: PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Number of subjects with booster responses for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

Timeframe: At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations

Timeframe: PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations

Timeframe: At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)

Number of subjects with booster responses for anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies

Timeframe: At Month 2 (one month post Boostrix vaccination)

Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

Timeframe: At Day 0 before (PRE) Boostrix vaccination

Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

Timeframe: At Month 2 (one month post Boostrix vaccination)

Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies

Timeframe: PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)

Number of subjects with vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies

Timeframe: At Month 2 (one month after vaccination with Menactra vaccine)

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within 4-days (Day 0-3) after each dose and across doses

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

Timeframe: Within 4-days (Days 0-3) after each dose and across doses

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

Timeframe: Within the 31-day (Days 0-30) period after each vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the entire study period (Day 0 - Month 2)

Interventions:
  • Biological/vaccine: Boostrix®
  • Biological/vaccine: Menactra™
    • Enrollment:
    1344
    Primary completion date:
    2006-08-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Friedland et al. Immunogenicity of coadministered Tdap and MCV4 vaccines compared to separately administered vaccines. Accepted for poster presentation at ICAAC 2007
    Weston et al. Reactogenicity of concomitant and separately administered Tdap and MCV4 vaccines. Accepted for poster presentation at ICAAC 2007
    Weston WM et al. (2011) Immunogenicity and reactogenicity of co-administered tetanus-diphtheria-acellular pertussis (Tdap) and tetravalent meningococcal conjugate (MCV4) vaccines compared to their separate administration. Vaccine. 29(5):1017-1022.
    Medical condition
    acellular pertussis, Tetanus, Diphtheria
    Product
    SB776423
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to August 2006
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 18 years
    Accepts healthy volunteers
    Yes
    • Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
    • Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.
    • Administration of a pre-school booster of DTP vaccine within the previous 5 years
    • Administration of a diphteria-tetanus (Td) booster within the previous 5 years
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
    • Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.
    • Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.
    Exclusion criteria:
    • Administration of a pre-school booster of DTP vaccine within the previous 5 years
    • Administration of a diphteria-tetanus (Td) booster within the previous 5 years
    • Previous vaccination against N. meningitidis
    • Hypersensitivity to latex
    • History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines
    • History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause
    • Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized
    • Previous history of Guillain-Barré syndrome

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Annapolis, Maryland, United States, 21401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Frederick, Maryland, United States, 21702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16508
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greenville, Pennsylvania, United States, 16125
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84121
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Jordan, Utah, United States, 84084
    Status
    Study Complete
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    Showing 1 - 6 of 24 Results

    Study documents

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

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-08-08
    Actual study completion date
    2006-08-08

    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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