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

Phase 4

• Conditions: Hib Immunisation in Very Preterm-born Infants; Pertussis Immunisation in Very Preterm-born Infants
• Interventions: Biological: Three vaccine injections DTP-pertussis-Hib; Biological: Two vaccine injections DTP-pertussis-Hib

• 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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
• signed parental consent

Exclusion Criteria

• immunodeficiency
• vaccine contra-indication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three vaccine injections	Three vaccine injections DTP-pertussis-Hib	Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib).
Two vaccine injections	Two vaccine injections DTP-pertussis-Hib	Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib).

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