Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates
- Conditions
- Hib Immunisation in Very Preterm-born InfantsPertussis Immunisation in Very Preterm-born Infants
- Registration Number
- NCT02179996
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
- signed parental consent
- immunodeficiency
- vaccine contra-indication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hib antibody dosage in blood sample 5 months after birth
- Secondary Outcome Measures
Name Time Method Pertussis antibody dosage in blood sample 5 months after birth
Trial Locations
- Locations (2)
Centre Hospitalier Regional et Universitaire, Maternite Regionale
🇫🇷Nancy, France
Centre Hospitalier de Thionville
🇫🇷Thionville, France
Centre Hospitalier Regional et Universitaire, Maternite Regionale🇫🇷Nancy, France