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Clinical Trials/EUCTR2022-001541-20-IS
EUCTR2022-001541-20-IS
Active, not recruiting
Phase 1

Antibiotic exposure in early infancy and immune responses to vaccinations. - e-INFANT-2

Not provided0 sites200 target enrollmentMay 29, 2024
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Not provided
Enrollment
200
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 29, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Immune suppression, allergy to vaccine components or any other contraindication to receiving the vaccines.

Outcomes

Primary Outcomes

Not specified

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