Clinical trial NCT00322361: Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Official title: A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Hepatocellular Carcinoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-05-05
Enrollment: 566
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hepatitis B Vaccine \[Recombinant\] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: \[1\] induce protection against the morbidity and mortality of acute hepatitis B virus infection, \[2\] reduce the incidence of chronic infection in vaccinated populations, and \[3\] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine \[Recombinant\] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine \[Recombinant\] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age)
* Born to mothers with documented negative test for HBsAg within 9 months prior to delivery

Exclusion Criteria:

* Infant born to mother with no prenatal care
* Known or suspected impairment of immunologic function
* Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.)
* Recent(\<72 hours) history of febrile illness \>/= 99.5 degrees F (\>/= 37.5 degrees C) axillary or \>/= 100.5 degrees F (\>/= 38.1 degrees C) rectal
* Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant
* Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study
* Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast)
* Any infant who cannot be adequately followed for study visits during the course of the clinical study
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Primary outcomes:
measure: Geometric mean titer to hepatitis B surface antigen at Month 7
timeFrame: 4 weeks Post Dose 3
Secondary outcomes:
measure: Safety and tolerability including use of Vaccination Report Card
timeFrame: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Minervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. doi: 10.1016/j.vaccine.2011.12.095. Epub 2012 Jan 5.