Overview
Sponsor-declared trial summary
Pertussis
Aim of the study is to investigate the possible long-lasting differences in the pertussis immunity between the children whose mothers were vaccinated during pregnancy and control children at the age of 48 months.
Key facts
- Sponsor
- Varsinais-Suomen hyvinvointialue
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 7 May 2024 → 7 Jul 2025
- Decision date (initial)
- 2024-04-30
- 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
Aim of the study is to investigate the possible long-lasting differences in the pertussis immunity between the children whose mothers were vaccinated during pregnancy and control children at the age of 48 months.
Conditions and MedDRA coding
Pertussis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10069577 | Pertussis immunisation | 100000004865 |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-001986-34 | Exploring the impact of pertussis immunization during pregnancy on the differences in immune response of infants after primary immunization with an acellular pertussis containing vaccine: an open label study |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participation and completion of the 6-month timepoint in the original MIFI study will be the only inclusion criterion.
Exclusion criteria 1
- The exclusion criteria include decline from or clinical conditions that disallow the study procedures.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PT-specific IgG antibody geometric mean concentration (GMC) at 4 years+28 days in children from Arm 1 versus Arm 2.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4559753 · Product
- Active substance
- Poliovirus (Inactivated) Type 3 (Saukett Strain)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- 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
- J07CA02 — DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS
- Marketing authorisation
- 13676
- MA holder
- SANOFI PASTEUR EUROPE
- MA country
- Finland
- Paediatric formulation
- Yes
- 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 | 138 | 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 | 2024-05-07 | 2025-07-07 | 2024-05-20 | 2025-06-06 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-11 | Finland | Acceptable 2024-04-29
|
2024-04-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-06 | Finland | Acceptable 2024-04-29
|
2024-05-06 |