NCT00322361

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

May 2, 2006

Last Update Submit

March 15, 2017

Conditions

Hepatitis BHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Geometric mean titer to hepatitis B surface antigen at Month 7

    4 weeks Post Dose 3

Secondary Outcomes (1)

  • Safety and tolerability including use of Vaccination Report Card

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

Study Arms (2)

1

EXPERIMENTAL

Modified Process Hepatitis B Vaccine

Biological: Comparator: Modified process Hepatitis B Vaccine

2

ACTIVE COMPARATOR

Recombivax HB™

Biological: Comparator: RECOMBIVAX HB™

Interventions

Comparator: RECOMBIVAX HB™BIOLOGICAL

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

2
Comparator: Modified process Hepatitis B VaccineBIOLOGICAL

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

1

Eligibility Criteria

Age1 Day - 10 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22227229DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis BCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 5, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 16, 2017

Record last verified: 2017-03