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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TdaP vaccine | Experimental |
| |
| Td vaccine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TdaP vaccine SSI | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples | one month post-vaccination | |
| Serum anti-diphtheria antibody conc. in post-vac. serum samples | one month post -vaccination | |
| Serum anti-tetanus antibody conc. in post-vac. serum samples | one month post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination | one month post-vaccination | |
| Serum anti-diphtheria antibody conc. in pre-vac. serum samples | one month post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birgit Thierry-Carstensen, M.Sc. Pharm | Statens Serum Institut | Study Director |
| Carsten Heilmann, Professor MD | H:S Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H:S Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| aCROnordic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22776216 | Derived | 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. |
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| Td vaccine SSI | Biological | 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) |
|
| Serum anti-tetanus antibody conc. in pre-vac. serum samples | one month post- vaccination |
| Hoersholm |
| 2970 |
| Denmark |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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