Clinical trial NCT01033877: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Immunisation, active
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Healthy female or male adult of ≥ 18 years of age
2. Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
3. Signed informed consent
4. Prepared to grant authorised persons access to medical records
5. Likely to comply with instructions

Exclusion Criteria:

1. Congenital or acquired immunodeficiency or progressive neurologic disease
2. Uncontrolled epilepsy or progressive encephalopathy
3. Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
4. Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine within 5 years before inclusion
5. Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine within 5 years before inclusion
6. Known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion
7. Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
8. Vaccinated with a live or inactivated vaccine within 1 month before inclusion
9. Administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion
10. Administration of any investigational drug product or vaccine within 1 month before inclusion
11. Females if pregnant or breastfeeding or not willing to use contraception during the trial

Primary outcomes:
measure: Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples
timeFrame: one month post-vaccination
measure: Serum anti-diphtheria antibody conc. in post-vac. serum samples
timeFrame: one month post -vaccination
measure: Serum anti-tetanus antibody conc. in post-vac. serum samples
timeFrame: one month post-vaccination
Secondary outcomes:
measure: Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination
timeFrame: one month post-vaccination
measure: Serum anti-diphtheria antibody conc. in pre-vac. serum samples
timeFrame: one month post-vaccination
measure: Serum anti-tetanus antibody conc. in pre-vac. serum samples
timeFrame: one month post- vaccination
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: H:S Rigshospitalet
city: Hoersholm
country: Denmark
facility: aCROnordic
Study officials:
affiliation: Statens Serum Institut
name: Birgit Thierry-Carstensen, M.Sc. Pharm
role: STUDY_DIRECTOR
affiliation: H:S Rigshospitalet
name: Carsten Heilmann, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.