Overview
Sponsor-declared trial summary
Diphtheria, tetanus, pertussis (wooping cough)
To study pertussis, diphtheria, and tetanus immunity in health care workers before their booster vaccination with dTap vaccine and the immunological response 4 weeks after the booster vaccination.
Key facts
- Sponsor
- Varsinais-Suomen hyvinvointialue
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 3 May 2024 → 28 Feb 2026
- Decision date (initial)
- 2024-04-24
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To study pertussis, diphtheria, and tetanus immunity in health care workers before their booster vaccination with dTap vaccine and the immunological response 4 weeks after the booster vaccination.
Conditions and MedDRA coding
Diphtheria, tetanus, pertussis (wooping cough)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10054131 | Tetanus immunisation | 100000004865 |
| 21.1 | PT | 10054129 | Diphtheria immunisation | 100000004865 |
| 21.1 | PT | 10069577 | Pertussis immunisation | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Working constantly with infants <12 months of age and thus requirement for dTap booster vaccination every 5 years
- > 4 years from the previous dTap vaccination
- Compliant with study procedures (2 visits with questionnaires, blood and MLF samples, planning to receive the dTap vaccine)
Exclusion criteria 1
- Medical exempt not being able to be vaccinated (e.g. severe allergic reaction from some of the components in the vaccine)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The percentage of study participants with PT-specific IgG antibody geometric mean concentration (GMC) ≥5 IU/mL 0-7 days pre-vaccination.
Secondary endpoints 7
- PT-specific IgG antibody geometric mean concentration (GMC) 28 days after vaccination.
- The difference in FHA, PRN, and Fimbriae 2/3 IgG antibody GMCs pre- and 28 days post-vaccination.
- Pertussis antigen-specific plasma B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot.
- Pertussis antigen-specific memory B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot.
- Pertussis antigen-specific T-cell responses determined by cytokine analysis either from pertussis antigen stimulated whole blood samples/PBMC’s and/or supernatants.
- Assays measuring pertussis specific functional immunity include: PT neutralization; PT epitope specific antibodies; avidity; adherence inhibition; bactericidal activity; bacterial opsonization and phagocytosis undertaken on serum samples taken pre- and 28 days post-vaccination.
- Tetanus- and diphtheria toxoid-specific IgG antibody GMC measured by ELISA pre- and 28 days post-vaccination.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4831311 · Product
- Active substance
- Diphtheria Toxoid
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
- Marketing authorisation
- 32502
- MA holder
- SANOFI PASTEUR EUROPE
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Varsinais-Suomen hyvinvointialue
- Sponsor organisation
- Varsinais-Suomen hyvinvointialue
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- Lauri Ivaska
Public contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- Lauri Ivaska
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-05-03 | 2026-02-28 | 2024-05-07 | 2026-01-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-05 | Finland | Acceptable 2024-04-23
|
2024-04-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-24 | Finland | Acceptable 2024-04-23
|
2024-04-24 |