Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates (VacciPrema)
Primary Purpose
Hib Immunisation in Very Preterm-born Infants, Pertussis Immunisation in Very Preterm-born Infants
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Three vaccine injections DTP-pertussis-Hib
Two vaccine injections DTP-pertussis-Hib
Sponsored by
About this trial
This is an interventional prevention trial for Hib Immunisation in Very Preterm-born Infants focused on measuring Vaccination, Very preterm-born infants, Hib immunisation, Pertussis immunisation
Eligibility Criteria
Inclusion Criteria:
- infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
- signed parental consent
Exclusion Criteria:
- immunodeficiency
- vaccine contra-indication
Sites / Locations
- Centre Hospitalier Regional et Universitaire, Maternite Regionale
- Centre Hospitalier de Thionville
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Three vaccine injections
Two vaccine injections
Arm Description
Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib).
Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib).
Outcomes
Primary Outcome Measures
Hib antibody dosage in blood sample
Secondary Outcome Measures
Pertussis antibody dosage in blood sample
Full Information
NCT ID
NCT02179996
First Posted
July 1, 2014
Last Updated
July 27, 2015
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02179996
Brief Title
Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates
Acronym
VacciPrema
Official Title
Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hib Immunisation in Very Preterm-born Infants, Pertussis Immunisation in Very Preterm-born Infants
Keywords
Vaccination, Very preterm-born infants, Hib immunisation, Pertussis immunisation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Three vaccine injections
Arm Type
Active Comparator
Arm Description
Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib).
Arm Title
Two vaccine injections
Arm Type
Experimental
Arm Description
Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib).
Intervention Type
Biological
Intervention Name(s)
Three vaccine injections DTP-pertussis-Hib
Intervention Description
DTP-pertussis-Hib injections at two, three, four months after birth
Intervention Type
Biological
Intervention Name(s)
Two vaccine injections DTP-pertussis-Hib
Intervention Description
DTP-pertussis-Hib injections are administered at two and four months after birth
Primary Outcome Measure Information:
Title
Hib antibody dosage in blood sample
Time Frame
5 months after birth
Secondary Outcome Measure Information:
Title
Pertussis antibody dosage in blood sample
Time Frame
5 months after birth
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
signed parental consent
Exclusion Criteria:
immunodeficiency
vaccine contra-indication
Facility Information:
Facility Name
Centre Hospitalier Regional et Universitaire, Maternite Regionale
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Centre Hospitalier de Thionville
City
Thionville
ZIP/Postal Code
57100
Country
France
12. IPD Sharing Statement
Learn more about this trial
Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates
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