Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Hepatitis B

Treatments

Biological: Comparator: RECOMBIVAX HB™

Biological: Comparator: Modified process Hepatitis B Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00322361

V232-056

2006_007

Details and patient eligibility

About

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.

Enrollment

566 patients

Sex

All

Ages

1 to 10 days old

Volunteers

Accepts Healthy Volunteers

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