Hib Immunisation in Very Preterm-born Infants Clinical Trial
Official title:
Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention