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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014