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Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study (VacciPrema)
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.
Details
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 160 |
| Start date | 2014-01 |
| Completion | 2015-09 |
Conditions
- Hib Immunisation in Very Preterm-born Infants
- Pertussis Immunisation in Very Preterm-born Infants
Interventions
- Three vaccine injections DTP-pertussis-Hib
- Two vaccine injections DTP-pertussis-Hib
Primary outcomes
- Hib antibody dosage in blood sample — 5 months after birth
Countries
France