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

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 4

Conditions: Hib Immunisation in Very Preterm-born Infants; Pertussis Immunisation in Very Preterm-born Infants

Treatments: Biological: Three vaccine injections DTP-pertussis-Hib; Biological: Two vaccine injections DTP-pertussis-Hib

Study type: Interventional

Funder types: Other

Identifiers

NCT02179996

2013-A01377-28

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• immunodeficiency
• vaccine contra-indication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Three vaccine injections

Active Comparator group

Description:

Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib).

Treatment:

Biological: Three vaccine injections DTP-pertussis-Hib

Two vaccine injections

Experimental group

Description:

Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib).

Treatment:

Biological: Two vaccine injections DTP-pertussis-Hib