Trial document




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  DRKS00000180

Trial Description

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Title

A Randomised, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Tdap-IPV Vaccine and a Tetanus Monovalent Vaccine in Healthy Adults 18 Years of Age and Older

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Trial Acronym

RPV02C

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this Clinical Study is to demonstrate that a combined tetanus, diphtheria, pertussis and poliomyelitis vaccine (REPEVAX®) will provide similar protection against tetanus as a Tetanus vaccine alone in healthy adults.

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Brief Summary in Scientific Language

The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000180
  •   2009/10/07
  •   2009/06/25
  •   no
  •   Approved
  •   2009-035-ff, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   NCT00928785  (ClinicalTrials.gov)
  •   837/01 
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Health Condition or Problem studied

  •   tetanus
  •   A35 -  Other tetanus
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Interventions/Observational Groups

  •   Biological: REPEVAX
    1 dose of 0.5 mL at Day 0
  •   Biological: Monovalent Tetanus vaccine
    1 dose of 0.5 mL at Day 0
    Active Comparator
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
  •   III
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Primary Outcome

Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) >= 0.1 IU/mL) [ Time Frame: 10 days ] [ Designated as safety issue: No ]

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Secondary Outcome

* Geometric Mean Titre (GMT) for tetanus antibodies in both groups [ Time Frame: Day 0, Day 1 and Day 28 ] [ Designated as safety issue: No ]
* The anti-tetanus seroprotection rate (antibody titre >= 0.1 IU/mL in ELISA) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
* Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events [ Time Frame: D0 to Day 7 ] [ Designated as safety issue: Yes ]
* Percentage of subjects with serious adverse events [ Time Frame: D0 to Day 28 ] [ Designated as safety issue: Yes ]

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Countries of Recruitment

  •   France
  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/07/15
  •   456
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

* Healthy adults aged >=18 years
* Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence)
* Subject with vaccination history of a primary immunisation with a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the local vaccination calendar
* Negative urine pregnancy test for female subjects of child-bearing potential. A female subject who is of reproductive potential must agree to remain abstinent or use (or have her partner use) acceptable methods of birth control during the study period
* Subject having signed the informed consent form prior to participation in the study

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Exclusion Criteria

* Acute severe illness or fever (>=38.0°C) within the last 3 days
* Hypersensitivity or known allergy to one of the components of one of the study vaccines (including formaldehyde, streptomycin, neomycin, polymyxin B, or glutaraldehyde)
* Anaphylactic or other allergic reactions to a previous dose of a vaccine containing diphtheria or tetanus toxoids or poliomyelitis viruses or pertussis (acellular or whole cell)
* Guillain Barré syndrome or neuropathy of brachial plexus following a previous vaccination with a tetanus toxoid containing vaccine
* Known encephalopathy after receipt of a pertussis vaccine or neurological disorders after an injection with the same antigens
* Progressive or unstable neurological disorder, uncontrolled seizures or progressive encephalopathy not stabilized
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Known malignant disease, note:
o subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs),
o subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and
o subjects with a history of other malignancies who have been disease-free for at least 5 years will be eligible for enrollment
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Immunosuppressive therapy:
o High dose (>= 20 mg/day prednisone equivalent) systemic (>= 14 days) corticosteroid treatment daily or on alternate day within the last 28 days (inhaled corticosteroids allowed)
o Chemotherapeutic agents used to treat cancer or other conditions
o Treatments associated with organ or bone marrow transplantation
* Immune dysfunction caused by a medical condition, or any other cause (e.g., congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma or generalized malignancy)
* Known severe thrombocytopenia or coagulation disorder contraindicating an intramuscular injection
* Administration of blood products including immunoglobulins within the last 90 days or planned before Visit 3
* Recent administration of a live vaccine (<=28 days) or an inactivated vaccine (<=14 days) or vaccination planned before Visit 3
* For female subjects, pregnancy (positive pregnancy test before first blood sample) or breast-feeding through Visit 3
* Planned participation in another clinical study during the present study period

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Addresses

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    • Sanofi Pasteur MSD
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    • Ms.  Dr. med.  Sarah  Jow 
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    • Sanofi Pasteur MSD GmbH
    • Mr.  Dr. rer. nat.  Hansjörg  Diehm 
    • Paul-Ehrlich-Straße 1
    • 69181  Leimen
    • Germany
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Sources of Monetary or Material Support

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    • Sanofi Pasteur MSD
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Status

  •   Recruiting complete, follow-up complete
  •   2009/12/08
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Trial Publications, Results and other Documents

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