A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00414050
First received: December 20, 2006
Last updated: May 19, 2009
Last verified: May 2009
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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:
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 More Information
Additional Information:
No publications provided by Merck
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 May 23, 2013