Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates
NCT ID: NCT02179996
Last Updated: 2015-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
160 participants
INTERVENTIONAL
2014-01-31
2015-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
Three vaccine injections DTP-pertussis-Hib
DTP-pertussis-Hib injections at two, three, four months after birth
Two vaccine injections
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
Interventions
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Three vaccine injections DTP-pertussis-Hib
DTP-pertussis-Hib injections at two, three, four months after birth
Two vaccine injections DTP-pertussis-Hib
DTP-pertussis-Hib injections are administered at two and four months after birth
Eligibility Criteria
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Inclusion Criteria
* signed parental consent
Exclusion Criteria
* vaccine contra-indication
6 Months
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Pr Rachel VIEUX
Professor Rachel Vieux
Locations
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Centre Hospitalier Regional et Universitaire, Maternite Regionale
Nancy, , France
Centre Hospitalier de Thionville
Thionville, , France
Countries
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Other Identifiers
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2013-A01377-28
Identifier Type: -
Identifier Source: org_study_id
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