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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
546
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.
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.
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)
Time frame: 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).
Time frame: 11 months (1 month after the third dose)
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)
Time frame: 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)
Time frame: 11 months (1 month after the third dose)
The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
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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)
Time frame: 11 months (1 month after the third dose)