drugset / Trial / NCT02179996

Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates

NCT02179996 ↗

Phase 4 Unknown 160 enrolled Central Hospital, Nancy, France
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2014-01
Primary completion
2015-06
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator DTP-pertussis-Hib Vaccine — —

Indications

No indication recorded.