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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three vaccine injections | Active Comparator | 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 | Experimental | Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three vaccine injections DTP-pertussis-Hib | Biological | DTP-pertussis-Hib injections at two, three, four months after birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hib antibody dosage in blood sample | 5 months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Pertussis antibody dosage in blood sample | 5 months after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regional et Universitaire, Maternite Regionale | Nancy | 54000 | France | |||
| Centre Hospitalier de Thionville |
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| Two vaccine injections DTP-pertussis-Hib | Biological | DTP-pertussis-Hib injections are administered at two and four months after birth |
|
| Thionville |
| 57100 |
| France |