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A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

NCT00414050 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1718

Last updated 2017-05-23

Study results available
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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®).

Conditions

Interventions

BIOLOGICAL

Modified Process Hepatitis B Vaccine (Experimental)

Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).

BIOLOGICAL

Hepatitis B Vaccine (Recombinant)

RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.

BIOLOGICAL

Hepatitis B Vaccine (Recombinant)

ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-06
Primary Completion
2007-10-22
Completion
2007-10-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00414050 on ClinicalTrials.gov