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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hib Immunisation in Very Preterm-born Infants, Pertussis Immunisation in Very Preterm-born Infants

Intervention / Treatment
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* Biological: Three vaccine injections DTP-pertussis-Hib
* Biological: Two vaccine injections DTP-pertussis-Hib


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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Three vaccine injections<br>Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib). | Biological: Three vaccine injections DTP-pertussis-Hib<br>* DTP-pertussis-Hib injections at two, three, four months after birth<br>|
| Experimental: Two vaccine injections<br>Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib). | Biological: Two vaccine injections DTP-pertussis-Hib<br>* DTP-pertussis-Hib injections are administered at two and four months after birth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hib antibody dosage in blood sample |  | 5 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pertussis antibody dosage in blood sample |  | 5 months after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Very preterm-born infants, Hib immunisation, Pertussis immunisation