Study on interchangeability of Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast) in infants under one year old.

UMIN ID: UMIN000017959

Registered date:20/06/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: -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).
• Date of first enrollment: 2015/06/20
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

0.25mL of Bimmugen(r) 0.25mL (Bim) and 0.25mL of Heptavax (r) -II 0.5mL (Hep) are vaccinated in the sequence of Bim-Hep-Bim.
0.25mL of Bimmugen(r) 0.25mL (Bim) and 0.25mL of Heptavax (r) -II 0.5mL (Hep) are vaccinated in the sequence of Hep-Bim-Bim.
0.25mL of Bimmugen(r) 0.25mL (Bim) and 0.25mL of Heptavax (r) -II 0.5mL (Hep) are vaccinated in the sequence of Hep-Hep-Bim.

Outcome(s)

• Primary Outcome: Safety. Types, severity, the number of days after vaccination, duration, and frequency of adverse events and side effects.
• Secondary Outcome: Immunogenicity. Change of HBs antibody (seroconversion rate)

Key inclusion & exclusion criteria

• Age minimum: 2months-old
• Age maximum: 6months-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Kaketsuken (The Chemo-Sero-Therapeutic Research Institute)
• Source(s) of Monetary Support: Kaketsuken (The Chemo-Sero-Therapeutic Research Institute)