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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis B Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Hepatocellular Carcinoma Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Virus Diseases

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: RECOMBIVAX HB™

Biological

RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.

Comparator: Modified process Hepatitis B Vaccine

Biological

Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.

Primary outcomes

Geometric mean titer to hepatitis B surface antigen at Month 7

Time frame: 4 weeks Post Dose 3

Secondary outcomes

Safety and tolerability including use of Vaccination Report Card

Time frame: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: May 5, 2006
Registry last updated: Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed