HealthyPhase 3NCT00928785
Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults
A Phase 3 study testing REPEVAX and Monovalent Tetanus vaccine in people with Healthy, run by Sanofi Pasteur, a Sanofi Company at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REPEVAX and Monovalent Tetanus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jul 2009to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany5 sites
Study site
Heilbronn, 74072
Study site
Künzig, 94550
Study site
Nettersheim, 53947
Study site
Offenbach, 63071
Study site
Reichenbach/Vogtland, 8468
France4 sites
Hôpital Gabriel Montpied - CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Hôpital St Eloi
Montpellier, 34295
Groupe Hospitalier Cochin - Saint-Vincent de Paul
Paris, 75014
Hôpital Bichat Claude Bernard
Paris, 75018
About this study
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
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.
- Conditions
- Healthy
- Being tested
- REPEVAX, Monovalent Tetanus vaccine
- Keywords
- Tetanus Vaccine, Tdap-IPV vaccine
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REPEVAXBiological
1 dose of 0.5 mL at Day 0
Monovalent Tetanus vaccineBiological
1 dose of 0.5 mL at Day 0
| Study group | Role | What they receive |
|---|---|---|
| REPEVAX | Experimental | Not described Receives: Biological: REPEVAX |
| Monovalent tetanus vaccine | Active comparator | Not described Receives: Biological: Monovalent Tetanus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)
Measured: 10 days
Secondary outcomes (4)
Geometric Mean Titre (GMT) for tetanus antibodies in both groups
Measured: Day 0, Day 1 and Day 28
The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)
Measured: Day 28
Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events
Measured: D0 to Day 7
Percentage of subjects with serious adverse events
Measured: D0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928785
- Sponsor's protocol ID
- RPV02C
- Status last verified
- Sep 2017
- First submitted
- 25 Jun 2009
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23032160
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00928785
- Acronym / sponsor ID
- RPV02C
- Conditions
- Healthy
- Keywords
- Tetanus Vaccine, Tdap-IPV vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2009 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REPEVAX | Experimental | Biological: REPEVAX |
| Monovalent tetanus vaccine | Active comparator | Biological: Monovalent Tetanus vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REPEVAX1 dose of 0.5 mL at Day 0 | Biological | REPEVAX |
| Monovalent Tetanus vaccine1 dose of 0.5 mL at Day 0 | Biological | Monovalent tetanus vaccine |
Primary outcome
Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)
Time frame: 10 days
4 secondary outcomes
Geometric Mean Titre (GMT) for tetanus antibodies in both groups
Time frame: Day 0, Day 1 and Day 28
The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)
Time frame: Day 28
Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events
Time frame: D0 to Day 7
Percentage of subjects with serious adverse events
Time frame: D0 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Derived from this study: PubMed 23032160Laurichesse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur, a Sanofi Company
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REPEVAX and Monovalent Tetanus vaccine in people with Healthy, run by Sanofi Pasteur, a Sanofi Company at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.