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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
Sponsor:
Information provided by (Responsible Party):
Pr Rachel VIEUX, Central Hospital, Nancy, France

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Hib antibody dosage in blood sample [ Time Frame: 5 months after birth ]

Secondary Outcome Measures :
  1. Pertussis antibody dosage in blood sample [ Time Frame: 5 months after birth ]


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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
  • signed parental consent

Exclusion Criteria:

  • immunodeficiency
  • vaccine contra-indication

Information from the National Library of Medicine

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


Locations
France
Centre Hospitalier Regional et Universitaire, Maternite Regionale
Nancy, France, 54000
Centre Hospitalier de Thionville
Thionville, France, 57100
Sponsors and Collaborators
Central Hospital, Nancy, France

Responsible Party: Pr Rachel VIEUX, Professor Rachel Vieux, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02179996     History of Changes
Other Study ID Numbers: 2013-A01377-28
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Pr Rachel VIEUX, Central Hospital, Nancy, France:
Vaccination
Very preterm-born infants
Hib immunisation
Pertussis immunisation

Additional relevant MeSH terms:
Whooping Cough
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs