HealthyPhase 3NCT01033877
Immunogenicity and Safety of Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine in Comparison to Tetanus and Diphtheria (Td) Vaccine When Given as Booster Vaccinations to Adults
A Phase 3 study testing TdaP vaccine SSI and Td vaccine SSI in people with Healthy, run by Statens Serum Institut at 2 sites in Denmark.
Trial summary
The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine according to the Danish vaccination programme in… 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?
- TdaP vaccine SSI and Td vaccine SSI
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2010to Aug 2010
- 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 female or male adult of ≥ 18 years of age
- Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
- Signed informed consent
- Prepared to grant authorised persons access to medical records
- Likely to comply with instructions
Who cannot join
- Congenital or acquired immunodeficiency or progressive neurologic disease
- Uncontrolled epilepsy or progressive encephalopathy
- Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
- Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine within 5 years before inclusion
- Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine within 5 years before inclusion
- Known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion
Show all 11Show fewer
- Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
- Vaccinated with a live or inactivated vaccine within 1 month before inclusion
- Administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion
- Administration of any investigational drug product or vaccine within 1 month before inclusion
- Females if pregnant or breastfeeding or not willing to use contraception during the trial
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Immunogenicity and Safety of a Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine in Comparison to a Tetanus and Diphtheria (Td) Vaccine When Given as a Booster Vaccination to Adults
The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine according to the Danish vaccination programme in their childhood.
Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is the target population.
- Conditions
- Healthy
- Being tested
- TdaP vaccine SSI, Td vaccine SSI
- Keywords
- Immunisation, active
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TdaP vaccine SSIBiological
1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: >= 20 I.U. tetanus toxoid (T), >=2 I.U. diphtheria toxoid (d), 20 microgram pertussis toxoid (aP)
Td vaccine SSIBiological
1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: >= 20 I.U. tetanus toxoid (T), >=2 I.U. diphtheria toxoid (d)
| Study group | Role | What they receive |
|---|---|---|
| TdaP vaccine | Experimental | Not described Receives: Biological: TdaP vaccine SSI |
| Td vaccine | Active comparator | Not described Receives: Biological: Td vaccine SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples
Measured: one month post-vaccination
Serum anti-diphtheria antibody conc. in post-vac. serum samples
Measured: one month post -vaccination
Serum anti-tetanus antibody conc. in post-vac. serum samples
Measured: one month post-vaccination
Secondary outcomes (3)
Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination
Measured: one month post-vaccination
Serum anti-diphtheria antibody conc. in pre-vac. serum samples
Measured: one month post-vaccination
Serum anti-tetanus antibody conc. in pre-vac. serum samples
Measured: one month post- vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit Thierry-Carstensen, M.Sc. Pharm, Study director, Statens Serum InstitutCarsten Heilmann, Professor MD, Principal investigator, H:S Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033877
- Sponsor's protocol ID
- VTdaP-01
- Status last verified
- Jan 2013
- First submitted
- 16 Dec 2009
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Thierry-Carstensen B, Jordan K, Uhlving HH, Dalby T, Sorensen C, Jensen AM, Heilmann C. A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults. Vaccine. 2012 Aug 10;30(37):5464-71. doi: 10.1016/j.vaccine.2012.06.073. Epub 2012 Jul 6.
PubMed 22776216
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine in Comparison to a Tetanus and Diphtheria (Td) Vaccine When Given as a Booster Vaccination to Adults
- ClinicalTrials.gov ID
- NCT01033877
- Acronym / sponsor ID
- VTdaP-01
- Conditions
- Healthy
- Keywords
- Immunisation, active
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Dec 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 clinical trial is a phase III, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine according to the Danish vaccination programme in their childhood.
Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is the target population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TdaP vaccine | Experimental | Biological: TdaP vaccine SSI |
| Td vaccine | Active comparator | Biological: Td vaccine SSI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy female or male adult of ≥ 18 years of age
- Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
- Signed informed consent
- Prepared to grant authorised persons access to medical records
- Likely to comply with instructions
Key exclusion criteria (11 listed)
- Congenital or acquired immunodeficiency or progressive neurologic disease
- Uncontrolled epilepsy or progressive encephalopathy
- Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
- Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine within 5 years before inclusion
- Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine within 5 years before inclusion
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 |
|---|---|---|
| TdaP vaccine SSI1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: >= 20 I.U. tetanus toxoid (T), >=2 I.U. diphtheria toxoid (d), 20 microgram pertussis toxoid (aP) | Biological | TdaP vaccine |
| Td vaccine SSI1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: >= 20 I.U. tetanus toxoid (T), >=2 I.U. diphtheria toxoid (d) | Biological | Td vaccine |
Primary outcome
Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples
Time frame: one month post-vaccination
Serum anti-diphtheria antibody conc. in post-vac. serum samples
Time frame: one month post -vaccination
Serum anti-tetanus antibody conc. in post-vac. serum samples
Time frame: one month post-vaccination
3 secondary outcomes
Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination
Time frame: one month post-vaccination
Serum anti-diphtheria antibody conc. in pre-vac. serum samples
Time frame: one month post-vaccination
Serum anti-tetanus antibody conc. in pre-vac. serum samples
Time frame: one month post- vaccination
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 21 Jan 2013.
- Derived from this study: PubMed 22776216Thierry-Carstensen B, Jordan K, Uhlving HH, Dalby T, Sorensen C, Jensen AM, Heilmann C. A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults. Vaccine. 2012 Aug 10;30(37):5464-71. doi: 10.1016/j.vaccine.2012.06.073. Epub 2012 Jul 6.
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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.
Birgit Thierry-Carstensen, M.Sc. Pharm study director
Statens Serum Institut
Carsten Heilmann, Professor MD principal investigator
H:S Rigshospitalet
2 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 TdaP vaccine SSI and Td vaccine SSI in people with Healthy, run by Statens Serum Institut at 2 sites in Denmark.
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 11 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 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples (time frame: one month post-vaccination). The study lists 3 primary outcomes in all. 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 NCT01033877, 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 21 Jan 2013.