Clinical trial NCT00928785: Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Tetanus Vaccine
Tdap-IPV vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)
timeFrame: 10 days
Secondary outcomes:
measure: Geometric Mean Titre (GMT) for tetanus antibodies in both groups
timeFrame: Day 0, Day 1 and Day 28
measure: The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)
timeFrame: Day 28
measure: Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events
timeFrame: D0 to Day 7
measure: Percentage of subjects with serious adverse events
timeFrame: D0 to Day 28
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied - CHU Clermont-Ferrand
city: Montpellier
country: France
facility: Hôpital St Eloi
city: Paris
country: France
facility: Groupe Hospitalier Cochin - Saint-Vincent de Paul
city: Paris
country: France
facility: Hôpital Bichat Claude Bernard
city: Heilbronn
country: Germany
city: Künzig
country: Germany
city: Nettersheim
country: Germany
city: Offenbach am Main
country: Germany
city: Reichenbach im Vogtland
country: Germany
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.