Clinical trial NCT00441012: Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
Official title: A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type B
Hepatitis B
Keywords: Haemophilus Influenza, type b and Hepatitis B
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 546
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine


Eligibility criteria: 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

Primary outcomes:
measure: The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
timeFrame: 11 months (1 month after the third dose)
measure: The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
timeFrame: 11 months (1 month after the third dose)
Secondary outcomes:
measure: The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
timeFrame: 0-11 months (recorded from first dose until the participant completes or discontinues)
measure: The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.
timeFrame: 11 months (1 month after the third dose)
measure: The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
timeFrame: 11 months (1 month after the third dose)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schodel FP, Bhuyan PK. Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants. Vaccine. 2011 Oct 19;29(45):7942-8. doi: 10.1016/j.vaccine.2011.08.071. Epub 2011 Aug 27.