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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928785
• Other study ID #: RPV02C
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2009
• Last updated: September 8, 2017
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Tetanus

Intervention

Biological:
• REPEVAX
1 dose of 0.5 mL at Day 0
• Monovalent Tetanus vaccine
1 dose of 0.5 mL at Day 0

Locations

Country	Name	City	State
France	Hôpital Gabriel Montpied - CHU Clermont-Ferrand	Clermont-Ferrand
France	Hôpital St Eloi	Montpellier
France	Groupe Hospitalier Cochin - Saint-Vincent de Paul	Paris
France	Hôpital Bichat Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) = 0.1 IU/mL)		10 days
Secondary	Geometric Mean Titre (GMT) for tetanus antibodies in both groups		Day 0, Day 1 and Day 28
Secondary	The anti-tetanus seroprotection rate (antibody titre = 0.1 IU/mL in ELISA)		Day 28
Secondary	Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events		D0 to Day 7
Secondary	Percentage of subjects with serious adverse events		D0 to Day 28