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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
802
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)
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)
H:S Rigshospitalet
Copenhagen, Denmark
aCROnordic
Hoersholm, Denmark
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
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
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