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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Biological: TdaP vaccine SSI; Biological: Td vaccine SSI

• Registration Number: NCT01033877
• Lead Sponsor: Statens Serum Institut

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Study Start: 2010-01
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 802

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TdaP vaccine	TdaP vaccine SSI	-
Td vaccine	Td vaccine SSI	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

H:S Rigshospitalet; 🇩🇰 Copenhagen, Denmark

aCROnordic; 🇩🇰 Hoersholm, Denmark