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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
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

First Posted
July 1, 2014
Last Updated
July 27, 2015
Sponsor
Central Hospital, Nancy, France
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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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