Overview

This trial is active, not recruiting.

Conditions hib immunisation in very preterm-born infants, pertussis immunisation in very preterm-born infants
Treatments three vaccine injections dtp-pertussis-hib, two vaccine injections dtp-pertussis-hib
Phase phase 4
Sponsor Central Hospital, Nancy, France
Start date January 2014
End date June 2015
Trial size 160 participants
Trial identifier NCT02179996, 2013-A01377-28

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib).
three vaccine injections dtp-pertussis-hib
DTP-pertussis-Hib injections at two, three, four months after birth
(Experimental)
Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib).
two vaccine injections dtp-pertussis-hib
DTP-pertussis-Hib injections are administered at two and four months after birth

Primary Outcomes

Measure
Hib antibody dosage in blood sample
time frame: 5 months after birth

Secondary Outcomes

Measure
Pertussis antibody dosage in blood sample
time frame: 5 months after birth

Eligibility Criteria

Male or female participants up to 6 months old.

Inclusion Criteria: - infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards - signed parental consent Exclusion Criteria: - immunodeficiency - vaccine contra-indication

Additional Information

Official title Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Central Hospital, Nancy, France.