DiphtheriaPhase 3NCT01249183
Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old
A Phase 3 study testing Concomitant administration and Separate administration in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 20 sites in 2 countries.
Trial summary
Primary objectives: To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- Concomitant administration and Separate administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 954 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Oct 2010to Sep 2011
- 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 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥60 years
- At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years
- No influenza vaccine administered during the last 6 months
Who cannot join
- Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years
- Receipt of pertussis-containing vaccine or 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
- 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 unstable neurological disorders
- Known or suspected immune dysfunction
- Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
- Chronic disease that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
France12 sites
Sanofi Pasteur MSD Investigational Site
Angers
Sanofi Pasteur MSD Investigational Site
Châtellerault
Sanofi Pasteur MSD Investigational Site
Clermont-Ferrand
Sanofi Pasteur MSD Investigational Site
Gières
Sanofi Pasteur MSD Investigational Site
Grenoble
Sanofi Pasteur MSD Investigational Site
Hérouville-Saint-Clair
Sanofi Pasteur MSD Investigational Site
La Rochelle
Sanofi Pasteur MSD Investigational Site
Lyon
Sanofi Pasteur MSD Investigational Site
Poitiers
Sanofi Pasteur MSD Investigational Site
Strasbourg
Sanofi Pasteur MSD Investigational Site
Tiercé
Sanofi Pasteur MSD Investigational Site
Tours
Germany8 sites
Sanofi Pasteur MSD Investigational Site
Berlin
Sanofi Pasteur MSD Investigational Site
Dresden
Sanofi Pasteur MSD Investigational Site
Essen
Sanofi Pasteur MSD Investigational Site
Hamburg
Sanofi Pasteur MSD Investigational Site
Heilbronn
Sanofi Pasteur MSD Investigational Site
Künzing
Sanofi Pasteur MSD Investigational Site
Potsdam
Sanofi Pasteur MSD Investigational Site
Reichenbach
About this study
Official title: An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older
Primary objectives:
To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.
Secondary objectives:
•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)
•Secondary safety objective: To describe the safety profile after vaccination in each group
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Being tested
- Concomitant administration, Separate administration
- Keywords
- Diphtheria, Tetanus, Pertussis (acellular, component), Diphteria, Biological / vaccine
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concomitant administrationBiological
1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)
Separate administrationBiological
1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
| Study group | Role | What they receive |
|---|---|---|
| 1- VAXIGRIP and REPEVAX concomitantly | Experimental | Not described Receives: Biological: Concomitant administration |
| 2-REPEVAX 28 days after VAXIGRIP | Active comparator | Not described Receives: Biological: Separate administration |
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 after vaccine administration
Tetanus seroprotection rate
Measured: 28 to 35 days after vaccine administration
Polio seroprotection rate
Measured: 28 to 35 days after vaccine administration
Pertussis antibody titre
Measured: 28 to 35 days after vaccine administration
Flu geometric mean of titres ratio
Measured: 28 to 35 days after vaccine administration
Secondary outcomes (3)
Solicited injection-site reactions, solicited systemic adverse reactions
Measured: From Day 0 to Day 7 following REPEVAX vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Measured: From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination
Number and proportion of Serious adverse events
Measured: From the first visit 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 posted29 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionSep 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 954 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
- NCT01249183
- Sponsor's protocol ID
- RPV03C
- Status last verified
- Sep 2017
- First submitted
- 17 Nov 2010
- 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, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older
- ClinicalTrials.gov ID
- NCT01249183
- Acronym / sponsor ID
- RPV03C
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Keywords
- Diphtheria, Tetanus, Pertussis (acellular, component), Diphteria, Biological / vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 954 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Nov 2010 (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 objectives:
To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.
Secondary objectives:
•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)
•Secondary safety objective: To describe the safety profile after vaccination in each group
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- VAXIGRIP and REPEVAX concomitantly | Experimental | Biological: Concomitant administration |
| 2-REPEVAX 28 days after VAXIGRIP | Active comparator | Biological: Separate administration |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥60 years
- At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years
- No influenza vaccine administered during the last 6 months
Key exclusion criteria (10 listed)
- Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years
- Receipt of pertussis-containing vaccine or 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
- 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 |
|---|---|---|
| Concomitant administration1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm) | Biological | 1- VAXIGRIP and REPEVAX concomitantly |
| Separate administration1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later | Biological | 2-REPEVAX 28 days after VAXIGRIP |
Primary outcome
Diphtheria seroprotection rate
Time frame: 28 to 35 days after vaccine administration
Tetanus seroprotection rate
Time frame: 28 to 35 days after vaccine administration
Polio seroprotection rate
Time frame: 28 to 35 days after vaccine administration
Pertussis antibody titre
Time frame: 28 to 35 days after vaccine administration
Flu geometric mean of titres ratio
Time frame: 28 to 35 days after vaccine administration
3 secondary outcomes
Solicited injection-site reactions, solicited systemic adverse reactions
Time frame: From Day 0 to Day 7 following REPEVAX vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Time frame: From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination
Number and proportion of Serious adverse events
Time frame: From the first visit 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
20 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 Concomitant administration and Separate administration in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 20 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 3 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 20 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 after vaccine administration). The study lists 5 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.