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Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT00928785
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: REPEVAX Biological: Monovalent Tetanus vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

Arm Intervention/treatment
Experimental: REPEVAX Biological: REPEVAX
1 dose of 0.5 mL at Day 0

Active Comparator: Monovalent tetanus vaccine Biological: Monovalent Tetanus vaccine
1 dose of 0.5 mL at Day 0




Primary Outcome Measures :
  1. Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL) [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Geometric Mean Titre (GMT) for tetanus antibodies in both groups [ Time Frame: Day 0, Day 1 and Day 28 ]
  2. The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA) [ Time Frame: Day 28 ]
  3. Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events [ Time Frame: D0 to Day 7 ]
  4. Percentage of subjects with serious adverse events [ Time Frame: D0 to Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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
  • Known malignant disease, note:

    • subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs),
    • subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and
    • subjects with a history of other malignancies who have been disease-free for at least 5 years will be eligible for enrollment
  • Immunosuppressive therapy:

    • 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)
    • Chemotherapeutic agents used to treat cancer or other conditions
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928785


Locations
France
Hôpital Gabriel Montpied - CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
Hôpital St Eloi
Montpellier, France, 34295
Groupe Hospitalier Cochin - Saint-Vincent de Paul
Paris, France, 75014
Hôpital Bichat Claude Bernard
Paris, France, 75018
Germany
Heilbronn, Germany, 74072
Künzig, Germany, 94550
Nettersheim, Germany, 53947
Offenbach am Main, Germany, 63071
Reichenbach im Vogtland, Germany, 8468
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00928785     History of Changes
Other Study ID Numbers: RPV02C
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Tetanus Vaccine
Tdap-IPV vaccine

Additional relevant MeSH terms:
Tetanus
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs