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

Study Overview
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Brief Summary
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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

Official Title
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A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process

Conditions
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Haemophilus Influenzae Type B, Hepatitis B

Intervention / Treatment
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* Biological: Comparator: Modified Process Vaccine
* Biological: Comparator: COMVAX™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Days
Maximum Age: 80 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Modified process Hib/Hep B vaccine | Biological: Comparator: Modified Process Vaccine<br>* Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.<br>|
| Active Comparator: 2<br>COMVAX™ | Biological: Comparator: COMVAX™<br>* COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Anti-HBs Seroprotected Participants 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) | 11 months (1 month after the third dose) | 
| The Anti-HBs GMT (Geometric Mean Titer) 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). | 11 months (1 month after the third dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | 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) | 0-11 months (recorded from first dose until the participant completes or discontinues) | 
| The Number of Anti-PRP Seroprotected Participants 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) | 11 months (1 month after the third dose) | 
| The Anti-PRP GMT (Geometric Mean Titer) 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) | 11 months (1 month after the third dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilus Influenza, type b and Hepatitis B