Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06079606 |
| Other study ID # |
e-INFANT-2 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 10, 2022 |
| Est. completion date |
December 31, 2027 |
Study information
| Verified date |
October 2023 |
| Source |
Landspitali University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This prospective cohort study will include 200 term children born in Landspitali University
Hospital in Iceland. The cohort will be divided into four groups according to antibiotic
exposure of which one is the control group. Children's immune responses to live oral
rotavirus vaccine as well as conventional vaccinations given at three, five and 12 months old
will be determined by measuring salivary and serologic responses. Responses will be compared
between the four groups. Stool samples will also be collected from participants and the
composition of the microbiome compared between the four groups.
Description:
This prospective cohort study will evaluate the development of the immune system by means of
evaluating the immune responses to oral rotavirus vaccine and the scheduled childhood
vaccinations in Iceland, at the age of three, five and 12 months, in four different groups of
term children born in Iceland.
The cohort will be divided into the following groups:
- Group A: Term children born with elective caesarean section (their mothers received
intra-operative antibiotics).
- Group B: Term vaginally born children and their mothers received intra-partum
antibiotics.
- Group C: Term vaginally born children that received systemic antibiotics during the
first week of life for at least 48 hours.
- Group D: Term vaginally born children that had not received systemic antibiotics at the
time of recruitment.
Parents of children born with elective caesarean section in Landspitali or born vaginally and
their mothers received intra-partum antibiotics as well as parents of children in the
Neonatal Intensive Care Unit receiving systemic antibiotics during the first week of life
will be offered to take part in the study (Groups A, B and C). Parents of children coming to
a five day old check up at the Children's Hospital in Landspitali will also be offered to
take part in the study (Group D). Sample size calculations show that to detect a 30%
difference in immune responses to vaccines with 80% power, 40 infants are needed for analysis
in each group. To account for late exclusions due to antibiotic use or drop-out due to other
reasons, 50 infants will be recruited to each group. Participants will receive vaccination
with the oral live attenuated rotavirus vaccine, Rotarix, at six weeks old and again at three
months old. Participants will receive vaccinations with Pentavac against diphtheria, tetanus,
pertussis, haemophilus influenza type B and polio and Synflorix against pneumococci at their
Health Care Centre according to scheduled childhood vaccinations in Iceland at three, five
and 12 months old. Salivary and blood samples will be taken from participants just before the
first vaccination with Rotarix at six weeks old and again at six months (four weeks after the
second dose of Pentavac and Synflorix) and at 13 months old (four weeks after the third dose
of Pentavac and Synflorix). Specific antibody levels against rotavirus, pertussis,
diphtheria, tetanus, haemophilus influenzae type B, polio virus and pneumococci will be
measured. Parents of participants will be given two stool sample kits and asked to take one
from their child at six weeks old (before the first dose of rotavirus vaccine) and then
another at three months old. In case of detection of differences in antibody response, these
samples will be sent for microbiome analysis.
