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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017959

Enrollment

Registered

2015-06-20

Start date

2015-06-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1, Infant whose age at the time of first vaccination is <= 2 months and > 6 months. 2, Infant without previous vaccination of recombinant adsorbed hepatitis B vaccines (prepared from yeast), and whose vaccination history is confirmed with a maternal handbook etc. 3, Infant whose legal representative gives written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety. Types, severity, the number of days after vaccination, duration, and frequency of adverse events and side effects.	—

Secondary

Measure	Time frame
Immunogenicity. Change of HBs antibody (seroconversion rate)	—

Countries

Japan

Contacts

Public ContactHiroko Kumashiro

SOUSEIKAI Hakata Clinic Planning & Coordination Dept.

hiroko-kumashiro@lta-med.com0922837701

Outcome results