Is the immune response to childhood vaccinations the same in children exposed to antibiotics early in life and those who are not exposed?
- Conditions
- Relationship between early antibiotic exposure and immune responses.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2022-001541-20-IS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
Term children born in Iceland in 2022-2023.
- Group A: Children delivered with elective caesarean section (their mothers received intra-operative antibiotics).
- Group B: Children delivered vaginally and their mothers received intra- partum antibiotics.
- Group C: Children delivered vaginally and received systemic antibiotics during the first week of life for at least 48 hours.
- Group D: Children born vaginally and did not receive systemic antibiotics during the first six months of life.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
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
Immune suppression, allergy to vaccine components or any other contraindication to receiving the vaccines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method