The intended use of the vaccine in this study is to increase the immunological protection against pertussis in adults who completed primary vaccination with diphtheria, tetanus and pertussis vaccine typically during their childhood. MedDRA version: 12.0 Level: LLT Classification code 10034738 Term: Pertussis
Conditions
Interventions
Trade Name: diTekiBooster
Pharmaceutical Form: Suspension for injection
Trade Name: diTeBooster
Pharmaceutical Form: Suspension for injection
Sponsors
Statens Serum Institut
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (e.g. Td, TdaP, TdaP-IPV, DTaP, DTaP-IPV or DTaP-IPV/PRP-T) within 5 years before inclusion 5. Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine (e.g. Act-HIB®, NeisVac-C®, Prohibit®, Menectra®, Hib-TITER®, Meningitec®, Menjugate® or Prevenar®) 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 |
|---|---|
| Main Objective: -To demonstrate anti-pertussis toxin (anti-PTx) booster responses in at least 60 % of TdaP booster vaccinated adults, defined from pre- and post-vaccination anti-PTx antibody concentrations. -To demonstrate the non-inferiority of TdaP compared to Td when given as a booster vaccination to adults, defined from the percentage of subjects with post-vaccination anti-diphtheria antibody concentrations and anti-tetanus antibody concentrations = 0.1 IU/mL ;Secondary Objective: -To describe and compare the safety profiles in TdaP and Td vaccinated subjects. -To describe pre- and post-vaccination geometric mean concentrations (GMCs) and reverse cumulative distribution curves, from pre- and post-vaccination anti-pertussis toxin (anti-PTx) antibody concentrations in TdaP vaccinated subjects. -To describe and compare pre- and post-vaccination GMCs and reverse cumulative distribution curves, from pre- and post-vaccination anti-diphtheria and anti-tetanus antibody concentrations in TdaP and Td vaccinated subjects ;Primary end point(s): -Serum anti-PTx antibody concentrations measured in pre-vaccination and one month post-vaccination serum samples by ELISA -Serum anti-diphtheria antibody concentrations measured in one month post-vaccination serum samples by a Vero Cell Assay -Serum anti-tetanus antibody concentrations measured in one month post-vaccination serum samples by ELISA | — |
Countries
Denmark
Outcome results
None listed