Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age.

Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age. - Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034064

Enrollment

100

Registered

2018-09-11

Start date

2018-09-11

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

Prevention of infection of hepatitis B.

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1, Infant without previous vaccination of hepatitis B vaccines, and who got 1st shot of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, according to routine vaccination schedule. 2, Infant whose legal representative gives written informed consent.

Exclusion criteria

Exclusion criteria: 1, Infant who does not plan to get 3 doses of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, according to routine vaccination schedule. 4, Infant judged not appropriate for this study by study physician.

Design outcomes

Primary

Measure	Time frame
Type, severity, timing, duration, and frequency of adverse events and side effects occurred within 28 days after vaccination of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL is collected. This information is collected after every 3 doses of vaccination.	—

Countries

Japan

Contacts

Public ContactHiroko Kumashiro

SOUSEIKAI Hakata Clinic Planning & Coordination Dept.

hiroko-kumashiro@lta-med.com0922837701

Outcome results