Hib Immunisation in Very Preterm-born Infants, Pertussis Immunisation in Very Preterm-born Infants
Conditions
Keywords
Vaccination, Very preterm-born infants, Hib immunisation, Pertussis immunisation
Brief summary
Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants. Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered. The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.
Interventions
BIOLOGICALThree vaccine injections DTP-pertussis-Hib
DTP-pertussis-Hib injections at two, three, four months after birth
BIOLOGICALTwo vaccine injections DTP-pertussis-Hib
DTP-pertussis-Hib injections are administered at two and four months after birth
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* infants born \< 33 weeks gestation in Nancy and Thionville Maternity Wards * signed parental consent
Exclusion criteria
* immunodeficiency * vaccine contra-indication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hib antibody dosage in blood sample | 5 months after birth |
Secondary
| Measure | Time frame |
|---|---|
| Pertussis antibody dosage in blood sample | 5 months after birth |
Countries
France
Outcome results
None listed