Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates (VacciPrema)
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|ClinicalTrials.gov Identifier: NCT02179996|
Recruitment Status : Unknown
Verified July 2015 by Pr Rachel VIEUX, Central Hospital, Nancy, France.
Recruitment status was: Active, not recruiting
First Posted : July 2, 2014
Last Update Posted : July 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hib Immunisation in Very Preterm-born Infants Pertussis Immunisation in Very Preterm-born Infants||Biological: Three vaccine injections DTP-pertussis-Hib Biological: Two vaccine injections DTP-pertussis-Hib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study|
|Study Start Date :||January 2014|
|Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||September 2015|
Active Comparator: Three vaccine injections
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
DTP-pertussis-Hib injections at two, three, four months after birth
Experimental: Two vaccine injections
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
DTP-pertussis-Hib injections are administered at two and four months after birth
- Hib antibody dosage in blood sample [ Time Frame: 5 months after birth ]
- Pertussis antibody dosage in blood sample [ Time Frame: 5 months after birth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179996
|Centre Hospitalier Regional et Universitaire, Maternite Regionale|
|Nancy, France, 54000|
|Centre Hospitalier de Thionville|
|Thionville, France, 57100|