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

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00928785
First received: June 25, 2009
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Healthy
Biological: REPEVAX
Biological: Monovalent Tetanus vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 456
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 MSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Fiquet MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00928785     History of Changes
Other Study ID Numbers: RPV02C
Study First Received: June 25, 2009
Last Updated: December 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi Pasteur MSD:
Tetanus Vaccine
Tdap-IPV vaccine

ClinicalTrials.gov processed this record on October 23, 2014