DiphtheriaPhase 4NCT01546909
Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
A Phase 4 study testing Diphtheria, tetanus, polio and pertussis vaccination in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 45 sites in France.
Trial summary
PRIMARY OBJECTIVES To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3 To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against… Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy 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
- 278 participants
- Where
- 45 sitesFrance
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 4
- 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 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301
Who cannot join
- Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
- Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
- Known or suspected immune dysfunction
- Receipt of medications / vaccination that may interfere with study assessments
- Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
- Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
Show all 9Show fewer
- Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- Any medical condition that might interfere with the evaluation of the study objectives
- Febrile illness
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
France45 sites
SPMSD Investigational Site 120
Angers
SPMSD Investigational Site 103
Arras
SPMSD Investigational Site 155
Asnières
SPMSD Investigational Site 125
Bersée
SPMSD Investigational Site 121
Besançon
SPMSD Investigational Site 141
Besançon
SPMSD Investigational Site 124
Blois
SPMSD Investigational Site 161
Blois
SPMSD Investigational Site 194
Boulogne-Billancourt
SPMSD Investigational Site 148
Brest
SPMSD Investigational Site 117
Caen
SPMSD Investigational Site 147
Caen
SPMSD Investigational Site 135
Châlons-en-Champagne
SPMSD Investigational Site 163
Champdeniers
SPMSD Investigational Site 145
Chigny-les-Roses
SPMSD Investigational Site 157
Cholet
SPMSD Investigational Site 101
Clamart
SPMSD Investigational Site 160
Collombey Les Belles
SPMSD Investigational Site 162
Collombey Les Belles
SPMSD Investigational Site 139
Dax
SPMSD Investigational Site 193
Draguignan
SPMSD Investigational Site 106
Essey-lès-Nancy
SPMSD Investigational Site 123
Essey-lès-Nancy
SPMSD Investigational Site 164
Essey-lès-Nancy
SPMSD Investigational Site 136
Floirac
SPMSD Investigational Site 114
Frouard
SPMSD Investigational Site 150
Haguenau
SPMSD Investigational Site 113
Illkirch-Graffenstaden
SPMSD Investigational Site 197
Le Havre
SPMSD Investigational Site 198
Le Havre
SPMSD Investigational Site 107
Lingolsheim
SPMSD Investigational Site 115
Louverné
SPMSD Investigational Site 140
Manduel
SPMSD Investigational Site 116
Maromme
SPMSD Investigational Site 153
Marseille
SPMSD Investigational Site 134
Montpellier
SPMSD Investigational Site 129
Nogent-sur-Marne
SPMSD Investigational Site 133
Ostwald
SPMSD Investigational Site 128
Poitiers
SPMSD Investigational Site 130
Pont-à-Mousson
SPMSD Investigational Site 151
Quimper
SPMSD Investigational Site 102
Rouen
SPMSD Investigational Site 110
Rouen
SPMSD Investigational Site 199
Rouen
SPMSD Investigational Site 152
Saint-Ouen
About this study
Official title: Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE
PRIMARY OBJECTIVES
- To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
- To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3
Read more
SECONDARY OBJECTIVES
- To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
- To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
- To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
- Conditions
- Diphtheria, Tetanus, Poliomyelitis
- Being tested
- Diphtheria, tetanus, polio and pertussis vaccination
- Medical subject headings
- Diphtheria, Tetanus, Poliomyelitis
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 TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
| Study group | Role | What they receive |
|---|---|---|
| TETRAVAC-ACELLULAIRE | 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.
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
Measured: Pre-booster dose (Day 0)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
Measured: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)
Measured: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)
Measured: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)
Measured: Pre-booster dose (Day 0)
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
Measured: 1 month post-booster dose
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
Measured: 1 month post-booster dose
Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)
Measured: 1 month post-booster dose
Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)
Measured: 1 month post-booster dose
Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)
Measured: 1 month post-booster dose
Secondary outcomes (8)
Geometric mean titer for diphtheria
Measured: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for tetanus
Measured: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 1
Measured: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 2
Measured: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 3
Measured: Pre-booster (Day 0) and 1 month post-booster dose
Solicited injection site and solicited systemic reactions
Measured: From Day 0 to Day 7 post vaccination
Unsolicited injection site reactions and unsolicited systemic adverse events
Measured: From Day 0 to Day 28 days post vaccination
Serious adverse events
Measured: From signature of informed consent up to last study 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 posted7 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 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
- NCT01546909
- Sponsor's protocol ID
- RVX01C
- Status last verified
- Sep 2017
- First submitted
- 2 Mar 2012
- 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
- Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE
- ClinicalTrials.gov ID
- NCT01546909
- Acronym / sponsor ID
- RVX01C
- Conditions
- Diphtheria, Tetanus, Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Mar 2012 (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 describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
- To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3
SECONDARY OBJECTIVES
- To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
- To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
- To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TETRAVAC-ACELLULAIRE | Experimental | Biological: Diphtheria, tetanus, polio and pertussis vaccination |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301
Key exclusion criteria (9 listed)
- Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
- Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
- Known or suspected immune dysfunction
- Receipt of medications / vaccination that may interfere with study assessments
- Known true hypersensitivity to any of the vaccine components or to a vaccine containing 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 TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0 | Biological | TETRAVAC-ACELLULAIRE |
Primary outcome
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
Time frame: Pre-booster dose (Day 0)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
Time frame: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)
Time frame: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)
Time frame: Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)
Time frame: Pre-booster dose (Day 0)
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
Time frame: 1 month post-booster dose
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
Time frame: 1 month post-booster dose
Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)
Time frame: 1 month post-booster dose
Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)
Time frame: 1 month post-booster dose
Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)
Time frame: 1 month post-booster dose
8 secondary outcomes
Geometric mean titer for diphtheria
Time frame: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for tetanus
Time frame: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 1
Time frame: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 2
Time frame: Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 3
Time frame: Pre-booster (Day 0) and 1 month post-booster dose
Solicited injection site and solicited systemic reactions
Time frame: From Day 0 to Day 7 post vaccination
Unsolicited injection site reactions and unsolicited systemic adverse events
Time frame: From Day 0 to Day 28 days post vaccination
Serious adverse events
Time frame: From signature of informed consent up to last study 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
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diphtheria, tetanus, polio and pertussis vaccination in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 45 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 1 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 45 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL (time frame: Pre-booster dose (Day 0)). The study lists 10 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.