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

Merck Sharp & Dohme (MSD) logo

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

Trial design

566 participants in 2 patient groups

1
Experimental group
Description:
Modified Process Hepatitis B Vaccine
Treatment:
Biological: Comparator: Modified process Hepatitis B Vaccine
2
Active Comparator group
Description:
Recombivax HB™
Treatment:
Biological: Comparator: RECOMBIVAX HB™

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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