Healthy
Conditions
Keywords
Immunisation, active
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.
Interventions
BIOLOGICALTdaP vaccine SSI
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)
BIOLOGICALTd vaccine SSI
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)
Sponsors
Statens Serum Institut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Serum anti-tetanus antibody conc. in pre-vac. serum samples | one month post- vaccination |
Countries
Denmark
Outcome results
None listed