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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Biological: REPEVAX; Biological: Monovalent Tetanus vaccine

• Registration Number: NCT00928785
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Study Start: 2009-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REPEVAX	REPEVAX	-
Monovalent tetanus vaccine	Monovalent Tetanus vaccine	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (4)

Hôpital Gabriel Montpied - CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital Bichat Claude Bernard; 🇫🇷 Paris, France

Groupe Hospitalier Cochin - Saint-Vincent de Paul; 🇫🇷 Paris, France

Hôpital St Eloi; 🇫🇷 Montpellier, France