Maternal pertussis Immunization in FInland Study - MIFI Study

Phase 1

• Conditions: Pertussis Infection; MedDRA version: 20.0Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-001986-34-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Mothers
• Only adult mothers who are generally healthy and with no chronic disease with regular therapy will be offered to be included.

Infants
• Infants born with = 37 weeks of gestational age
• Written informed consent given by parent(s) or legal guardian(s) who is aged =18 years
• Parent(s) or legal guardian(s) willing and able to comply with the requirements of the protocol for the duration of the study.
• Infants due to receive their primary aP immunizations, aged up to 3 months (+- 4 days)
• Maternal immunization:
Exclusively for Arm 1: Received dTap vaccine during the current pregnancy
Exclusively for Arm 2: Not received dTap during the current pregnancy

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Mothers
• Mothers who have received dTap vaccine during the last 2 years are excluded.
• Mothers will be excluded if there is any condition which in the opinion of the investigator may interfere with the ability to fulfill study
requirements (this may include plans to move house and language comprehension).
• Receipt of immunosuppressive treatment during pregnancy or known HIV positivity are also reasons for exclusion.

Infats
• Birth weight < 2500 g
• Child in care (with safeguarding in place)
• Children of parents who are on the delegation log for this study
• Prior or planned receipt of any other investigational vaccine/drug or if current participation in other research study, at investigator discretion
• Major congenital defects or serious chronic illness
• Bleeding disorder
• Confirmed or suspected immunodeficiency
• A family history of congenital or hereditary immunodeficiency
• Receipt of more than 1 week of immune-suppressants or immune modifying drugs (e.g. oral prednisolone > 0.5 ml/kg/day or intravenous
glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed.
• Administration of immunoglobulin and/or any blood products since birth or planned administration during the study period
• History of allergy to any component of the vaccine
• History of pertussis disease/whooping cough confirmed by laboratory analysis (serology, culture or other available methods)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified