An open, randomised parallel study investigating efficacy and safety of the human hepatitis B immunoglobulin BT088 after subcutaneous or intramuscular application for perinatal prophylaxis in infants born to HbsAg positive wome

• Conditions: Healthy mature male and female neonates of gestational week = 37+0 with indication for hepatitis B prophylaxis due to a HBsAg positive mother.; MedDRA version: 8.1Level: LLTClassification code 10054130Term: Hepatitis B immunisation

• Registration Number: EUCTR2006-000110-21-DE
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

•Male or female neonate of gestational week = 37+0
•Body weight = 2500 g
•Apgar score, 5 minutes value > 7
•Confirmation of HBsAg positive mother
•Available written informed consent of parents or legal guardian

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Infant is too small for gestational age (i.e., < 2500 g)
•Outpatient birth
•Known or suspected intrauterine infection
(e.g. rubella, parvovirus B19, cytomegalovirus)
•Complicated neonatal infection
•Congenital malformation requiring major surgery
•Known or suspected chromosomal aberration
•Known or suspected intolerance to immunoglobulins
or comparable substances (e.g., vaccination reaction)
•Known or suspected intolerance to proteins of human origin
•Known deficiency of immunoglobulin A in the family
(parents and siblings of the neonate)
•Suspected severe thrombocytopenia or any coagulation disorder
leading to contraindications for intramuscular injections
•Any further condition which according to the investigator results
in an undue risk for the infant during participation in this study
•Inability of the parents or the legal guardian to understand the
study-specific information and measures
•Inability or lacking motivation of the parents or the legal guardian
to have the child participate in the study
•Parents or legal guardian are employees of any involved study
investigator or any involved institution including study sponsor
•Parallel participation of the infant in another clinical trial or
treatment with another investigational product during this study
• Infants with an indwelling cannula for intravenous access

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified