Relationship between early antibiotic exposure and immune responses.
Conditions
Interventions
Trade Name: Rotarix
Product Name: Rotarix
Pharmaceutical Form: Powder and solvent for oral suspension
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Immune suppression, allergy to vaccine components or any other contraindication to receiving the vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study immune responses to rotavirus vaccine in children with different antibiotic exposure in early life.;Secondary Objective: Not applicable.;Primary end point(s): Specific salivary and serum IgA levels against rotavirus.;Timepoint(s) of evaluation of this end point: Salivary and serum samples are taken at six to eight weeks old (pre-vaccination status) and repeated at six and 13 months old (post-vaccination). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Multivariable modelling of risk factors for differences in immune responses.;Timepoint(s) of evaluation of this end point: At six and 13 months old. | — |
Countries
Iceland
Outcome results
None listed