Status:
COMPLETED
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Haemophilus Influenzae Type B
Hepatitis B
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
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 vacc...
Eligibility Criteria
Inclusion
- Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT00441012
Start Date
December 1 2006
End Date
June 1 2008
Last Update
March 19 2015
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