- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928785
Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults
September 8, 2017 updated by: Sanofi Pasteur, a Sanofi Company
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Clermont-Ferrand, France, 63000
- Hôpital Gabriel Montpied - CHU Clermont-Ferrand
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Montpellier, France, 34295
- Hôpital St Eloi
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Paris, France, 75014
- Groupe Hospitalier Cochin - Saint-Vincent de Paul
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Paris, France, 75018
- Hopital Bichat Claude Bernard
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-
-
-
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Heilbronn, Germany, 74072
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Künzig, Germany, 94550
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Nettersheim, Germany, 53947
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Offenbach am Main, Germany, 63071
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Reichenbach im Vogtland, Germany, 8468
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: REPEVAX
|
1 dose of 0.5 mL at Day 0
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Active Comparator: Monovalent tetanus vaccine
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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)
Time Frame: 10 days
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geometric Mean Titre (GMT) for tetanus antibodies in both groups
Time Frame: Day 0, Day 1 and Day 28
|
Day 0, Day 1 and Day 28
|
The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)
Time Frame: Day 28
|
Day 28
|
Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events
Time Frame: D0 to Day 7
|
D0 to Day 7
|
Percentage of subjects with serious adverse events
Time Frame: D0 to Day 28
|
D0 to Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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