Study on interchangeability of Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast) in infants under one year old.
Not Applicable
- Conditions
- -Prevention of infection of hepatitis B. -Prevention of mother-to-child transmission of hepatitis B virus (used with Anti-HBs Human Immune Globulin) -Prevention of onset of hepatitis B after accidental contamination of HBsAg positive and HBeAg positive blood (used with Anti-HBs Human Immune Globulin).
- Registration Number
- JPRN-UMIN000017959
- Lead Sponsor
- Kaketsuken (The Chemo-Sero-Therapeutic Research Institute)
- Brief Summary
All subjects acquired the antibody titer 10mIU/mL and over, which is necessary for infection prevention, after all triplet vaccination sequences of Bimmugen and Heptavax -II adopted in this study. Serious adverse reaction was not observed. Considering the above, usability / interchangeability of two different Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast) was confirmed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1, Infant with fever. 2, Infant with sever acute disease. 3, Infant allergic to substance of study vaccines. 4, Infant judged not appropriate for this study by study physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety. Types, severity, the number of days after vaccination, duration, and frequency of adverse events and side effects.
- Secondary Outcome Measures
Name Time Method Immunogenicity. Change of HBs antibody (seroconversion rate)