Modified Process Hepatitis B Vaccine in Healthy Neonates

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00322361

First received: May 2, 2006

Last updated: February 18, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 2, 2006

Last Updated Date

February 18, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Geometric mean titer to hepatitis B surface antigen at Month 7 [ Time Frame: 4 weeks Post Dose 3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Geometric mean titer to hepatitis B surface antigen at Month 7

Change History

Complete list of historical versions of study NCT00322361 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability including use of Vaccination Report Card [ Time Frame: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability including use of Vaccination Report Card

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Modified Process Hepatitis B Vaccine in Healthy Neonates

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Hepatitis B
Hepatocellular Carcinoma

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
Recombivax HB™

Intervention: Biological: Comparator: RECOMBIVAX HB™
Experimental: 2
Modified Process Hepatitis B Vaccine

Intervention: Biological: Comparator: Modified process Hepatitis B Vaccine

Publications *

Minervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schödel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. Epub 2012 Jan 5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

566

Completion Date

August 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 10 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00322361

Other Study ID Numbers ^ICMJE

2006_007, V232-056

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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