DiphtheriaPhase 3NCT01287949
Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older
A Phase 3 study testing Diphtheria, tetanus, polio and pertussis vaccination in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 12 sites in 2 countries.
Trial summary
Primary objective: To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Poliomyelitis
- What is being tested?
- Diphtheria, tetanus, polio and pertussis vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jan 2011to May 2012
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥40 years
- No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years
Who cannot join
- Medically diagnosed pertussis disease within the last 10 years
- Receipt of medication / vaccine that may interfere with study assessments
- Febrile illness or moderate or severe acute illness/infection
- Know pregnancy
- History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
- History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
Show all 10Show fewer
- History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders
- Known or suspected immune dysfunction
- Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
- Chronic disease or intercurrent illness that might interfere with study assessments
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
France6 sites
Sanofi Pasteur MSD investigational site
Clermont-Ferrand
Sanofi Pasteur MSD investigational site
Lille
Sanofi Pasteur MSD investigational site
Montpellier
Sanofi Pasteur MSD investigational site
Paris
Sanofi Pasteur MSD investigational site
Poitiers
Sanofi Pasteur MSD investigational site
Saint-Etienne
Germany6 sites
Sanofi Pasteur MSD investigational site
Balve
Sanofi Pasteur MSD investigational site
Berlin
Sanofi Pasteur MSD investigational site
Dülmen
Sanofi Pasteur MSD investigational site
Nuremberg
Sanofi Pasteur MSD investigational site
Offenbach
Sanofi Pasteur MSD investigational site
Rodgau
About this study
Official title: An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years
Primary objective:
- To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects
Read more
Secondary objectives:
- If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To describe the immune responses to REPEVAX in these subjects
- To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Pertussis
- Being tested
- Diphtheria, tetanus, polio and pertussis vaccination
- Keywords
- Diphtheria, Tetanus, Poliomyelitis, Pertussis (acellular), Biological/vaccine
- Medical subject headings
- Diphtheria, Tetanus, Poliomyelitis, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria, tetanus, polio and pertussis vaccinationBiological
1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later
| Study group | Role | What they receive |
|---|---|---|
| REPEVAX followed by REVAXIS administration | Experimental | Not described Receives: Biological: Diphtheria, tetanus, polio and pertussis vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diphtheria seroprotection rate
Measured: 28 to 35 days afeter each vaccine administration
Tetanus seroprotection rate
Measured: 28 to 35 days after each vaccine administration
Polio seroprotection rate
Measured: 28 to 35 days after each vaccine administration
Pertussis response rate
Measured: 28 to 35 days after REPEVAX administration
Secondary outcomes (3)
Solicited injection-site reactions, solicited systemic reactions
Measured: From day 0 to day 7 following REPEVAX and REVAXIS vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Measured: From day 0 to day 28 following REPEVAX and REVAXIS vaccination
Number and proportion of Serious adverse events
Measured: From the first vaccination to the last visit of the subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 342 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
- NCT01287949
- Sponsor's protocol ID
- RPV04C
- Status last verified
- Sep 2017
- First submitted
- 31 Jan 2011
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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
- An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years
- ClinicalTrials.gov ID
- NCT01287949
- Acronym / sponsor ID
- RPV04C
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Pertussis
- Keywords
- Diphtheria, Tetanus, Poliomyelitis, Pertussis (acellular), Biological/vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Feb 2011 (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.
Primary objective:
- To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects
Secondary objectives:
- If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To describe the immune responses to REPEVAX in these subjects
- To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REPEVAX followed by REVAXIS administration | Experimental | Biological: Diphtheria, tetanus, polio and pertussis vaccination |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged ≥40 years
- No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years
Key exclusion criteria (10 listed)
- Medically diagnosed pertussis disease within the last 10 years
- Receipt of medication / vaccine that may interfere with study assessments
- Febrile illness or moderate or severe acute illness/infection
- Know pregnancy
- History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
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 |
|---|---|---|
| Diphtheria, tetanus, polio and pertussis vaccination1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later | Biological | REPEVAX followed by REVAXIS administration |
Primary outcome
Diphtheria seroprotection rate
Time frame: 28 to 35 days afeter each vaccine administration
Tetanus seroprotection rate
Time frame: 28 to 35 days after each vaccine administration
Polio seroprotection rate
Time frame: 28 to 35 days after each vaccine administration
Pertussis response rate
Time frame: 28 to 35 days after REPEVAX administration
3 secondary outcomes
Solicited injection-site reactions, solicited systemic reactions
Time frame: From day 0 to day 7 following REPEVAX and REVAXIS vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Time frame: From day 0 to day 28 following REPEVAX and REVAXIS vaccination
Number and proportion of Serious adverse events
Time frame: From the first vaccination to the last visit of the subject
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.
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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
12 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 Diphtheria, tetanus, polio and pertussis vaccination in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 12 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 2 inclusion and 10 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 12 sites in France, Germany. 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?
Diphtheria seroprotection rate (time frame: 28 to 35 days afeter each vaccine administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.