Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Haemophilus Influenzae Type B

Hepatitis B

Treatments

Biological: Comparator: COMVAX™

Biological: Comparator: Modified Process Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00441012

V121-019

2007_513

Details and patient eligibility

About

To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine

Enrollment

546 patients

Sex

All

Ages

40 to 80 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers

Exclusion criteria

Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject
History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine
Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)
Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast)
Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
Receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
Known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids);
Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits