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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414050
• Other study ID #: 2006_053
• Secondary ID: V232-057
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2006
• Last updated: May 19, 2009
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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™).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1718
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 2 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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).
• 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.
• Comparator: ENGERIX-B
ENGERIX-B given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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®		7 months	No
Secondary	Induced (Effected) Geometric Mean Titer for Modified Process Vaccine (5 µg and 10 µg), RECOMBIVAX Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®		7 months	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site