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

Phase 3

Completed

• Conditions: Haemophilus Influenzae Type B; Hepatitis B

• Registration Number: NCT00441012
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-05-11
• Results First Submitted QC: 2009-05-19
• Results First Posted: 2009-07-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.	11 months (1 month after the third dose)	The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.	11 months (1 month after the third dose)	Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).

Secondary Outcome Measures

Name	Time	Method
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences	0-11 months (recorded from first dose until the participant completes or discontinues)	Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)
The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.	11 months (1 month after the third dose)	The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after; the third dose)
The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.	11 months (1 month after the third dose)	Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)