A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00414050
First received: December 20, 2006
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine", to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B™).


Condition Intervention Phase
Hepatitis B
Biological: Modified Process Hepatitis B Vaccine (Experimental)
Biological: Hepatitis B Vaccine (Recombinant)
Biological: Comparator: ENGERIX-B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Number of Seroresponders to the Modified Process Hepatitis B Vaccine (5µg and 10 µg Dose), RECOMBIVAX-HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B® [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Induced (Effected) Geometric Mean Titer for Modified Process Vaccine (5 µg and 10 µg), RECOMBIVAX Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B® [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 1718
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Modified Process Hepatitis B vaccine, 5 micrograms
Biological: Modified Process Hepatitis B Vaccine (Experimental)
Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months (Arm 1). Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Arm 3).
Active Comparator: 2
RECOMBIVAX HB™
Biological: Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB (currently licensed product) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months.
Experimental: 3
Modified process hepatitis B vaccine 10 micrograms
Biological: Modified Process Hepatitis B Vaccine (Experimental)
Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months (Arm 1). Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Arm 3).
Active Comparator: 4
ENGERIX-B
Biological: Comparator: ENGERIX-B
ENGERIX-B given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
Other Name: ENGERIX-B

  Eligibility

Ages Eligible for Study:   2 Months to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject (Participant) is a healthy infant approximately 2 months of age

Exclusion Criteria:

  • Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the subject
  • Subject's (Participant) birth mother did not receive any prenatal care
  • Subject (Participant) has previous history of hepatitis B infection
  • Subject (Participant) has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of subject
  • Subject (Participant) has had a fever within 72 hours of study start
  • Subject (Participant) has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of subject
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414050

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00414050     History of Changes
Other Study ID Numbers: 2006_053, V232-057
Study First Received: December 20, 2006
Results First Received: October 15, 2008
Last Updated: May 19, 2009
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 17, 2014