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


Phase 2
N/A
10 Days
Not Enrolling
Both
Hepatitis B, Hepatocellular Carcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Geometric mean titer to hepatitis B surface antigen at Month 7

Outcome Time Frame:

4 weeks Post Dose 3

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2006_007

NCT ID:

NCT00322361

Start Date:

May 2006

Completion Date:

August 2007

Related Keywords:

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

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