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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322361
• Other study ID #: V232-056
• Secondary ID: 2006_007
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2006
• Last updated: March 15, 2017
• Start date: May 2006
• Est. completion date: July 2007

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatocellular Carcinoma

Intervention

Biological:
• Comparator: RECOMBIVAX HB™
RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
• Comparator: Modified process Hepatitis B Vaccine
Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean titer to hepatitis B surface antigen at Month 7		4 weeks Post Dose 3
Secondary	Safety and tolerability including use of Vaccination Report Card		Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)

External Links

•   Click here to access a synopsis of the study results.