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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: REPEVAX; Biological: Monovalent Tetanus vaccine

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Hôpital Gabriel Montpied - CHU Clermont-Ferrand
  • Montpellier, France, 34295
    • Hôpital St Eloi
  • Paris, France, 75014
    • Groupe Hospitalier Cochin - Saint-Vincent de Paul
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard
• Germany
  • Heilbronn, Germany, 74072
  • Künzig, Germany, 94550
  • Nettersheim, Germany, 53947
  • Offenbach am Main, Germany, 63071
  • Reichenbach im Vogtland, Germany, 8468

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)	10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• Laurichesse H, Zimmermann U, Galtier F, Launay O, Duval X, Richard P, Sadorge C, Soubeyrand B. Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(R)) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries. Hum Vaccin Immunother. 2012 Dec 1;8(12):1875-81. doi: 10.4161/hv.22083. Epub 2012 Oct 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Tetanus Vaccine; Tdap-IPV vaccine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections; Tetanus
• Other Study ID Numbers: RPV02C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No