Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates

Hib Immunisation in Very Preterm-born Infants Clinical Trial

— VacciPrema  

Official title:

Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02179996
• Other study ID #: 2013-A01377-28
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 1, 2014
• Last updated: July 27, 2015
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2015
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: CPP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

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

• signed parental consent

Exclusion Criteria:

• immunodeficiency

• vaccine contra-indication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hib Immunisation in Very Preterm-born Infants
• Pertussis Immunisation in Very Preterm-born Infants
• Premature Birth
• Whooping Cough

Intervention

Biological:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Regional et Universitaire, Maternite Regionale	Nancy
France	Centre Hospitalier de Thionville	Thionville

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hib antibody dosage in blood sample		5 months after birth	No
Secondary	Pertussis antibody dosage in blood sample		5 months after birth	No