Healthy AdultPhase 3NCT00400309
Safety of REPEVAX® Given One Month After REVAXIS®
A Phase 3 study testing REPEVAX® after REVAXIS® in people with Healthy Adult, run by Sanofi Pasteur, a Sanofi Company at 4 sites in France.
Trial summary
Primary objective: To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- REPEVAX® after REVAXIS®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2006to Feb 2007
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses.
- Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine.
Who cannot join
- Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine
- Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C)
- Known immunological deficiency
- Known malignant disease
- Known neurological disorder
- Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days
Show all 9Show fewer
- Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- Any previous (≤ 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3
- Any recent administration (≤ 30 days) of a vaccine or scheduled vaccination
Trial locations and contacts
4 sites in 1 country.
France4 sites
Study site
Clermont-Ferrand
Study site
Lyon
Study site
Montpellier
Study site
Paris
About this study
Official title: A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults
Primary objective:
- To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.
Secondary objectives:
- To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
- To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.
- Conditions
- Healthy Adult
- Being tested
- REPEVAX® after REVAXIS®, REPEVAX® after Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REPEVAX® after REVAXIS®Biological
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
REPEVAX® after PlaceboBiological
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
| Study group | Role | What they receive |
|---|---|---|
| REPEVAX® after REVAXIS® | Experimental | REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). Receives: Biological: REPEVAX® after REVAXIS® |
| REPEVAX® after Placebo | Active comparator | Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). Receives: Biological: REPEVAX® after Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.
Measured: 7 days
Secondary outcomes (1)
injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 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
- NCT00400309
- Sponsor's protocol ID
- F06-Td5I-301
- Status last verified
- Sep 2017
- First submitted
- 15 Nov 2006
- Last updated
- 11 Sep 2017
- Results posted
- 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
- A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults
- ClinicalTrials.gov ID
- NCT00400309
- Acronym / sponsor ID
- F06-Td5I-301
- Conditions
- Healthy Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2006 (actual)
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 16 Nov 2006 (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 describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.
Secondary objectives:
- To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
- To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REPEVAX® after REVAXIS® | Experimental | Biological: REPEVAX® after REVAXIS®REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). |
| REPEVAX® after Placebo | Active comparator | Biological: REPEVAX® after PlaceboPlacebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses.
- Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine.
Key exclusion criteria (9 listed)
- Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine
- Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C)
- Known immunological deficiency
- Known malignant disease
- Known neurological disorder
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 |
|---|---|---|
| REPEVAX® after REVAXIS®Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated) | Biological | REPEVAX® after REVAXIS® |
| REPEVAX® after PlaceboTetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo | Biological | REPEVAX® after Placebo |
Primary outcome
injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.
Time frame: 7 days
1 secondary outcome
injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events
Time frame: 14 days
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REPEVAX® after REVAXIS® in people with Healthy Adult, run by Sanofi Pasteur, a Sanofi Company at 4 sites in France.
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 9 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 4 sites in 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?
injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. (time frame: 7 days). 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.