A clinical trial to evaluate the safety and reactogenicity of BEs Inactivated Japanese Encephalitis Vaccine.

A single centre open label phase-1 study to evaluate the Safety and Reactogenicity of BEs Inactivated JE vaccine in greater than or equal to 18 to 49 year old healthy adult male subjects. - None

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001086

Enrollment

Registered

2010-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: BE&#039

s Inactivated Japanese encephalitis vaccine: 6&micro

g/0.5mL dose administered intramuscularly on 0 and 28th day Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: -Healthy Indian adult male subjects between greater than or equal to 18 to -Free of significant health problems as established by medical history and clinical laboratory tests before entering into the study. -Written informed consent obtained prior to screening from Subjects or their legally acceptable representative. -Ability of the volunteer or his legally acceptable representative to understand and comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: -History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever. -Inability or unwillingness to abide by the requirements of the study -Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. -Any acute infection at the time of 1st vaccination. -History of severe hypersensitivity reactions (in particular to a component of the investigational vaccine, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission). -Volunteers with history of type-I diabetes, severe cardiopulmonary disorders, hepatobiliary / renal disorders and malignancy -Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame
1)Solicited local and systemic adverse events (AEs) 2)Solicited and unsolicited local and systemic adverse events (AEs) 3)All safety laboratory parameters (Haematology, serum chemistry and urinalysis) for any clinically significant changes. 4) Vital signsTimepoint: 1)During first 60 minutes post vaccination 2)During subsequent period of 7 days through subject diary and upto day 56 3)once at baseline and again at day 56. 4)once at baseline and again at each scheduled visit.	—

Measure

Time frame

1)Solicited local and systemic adverse events (AEs) 2)Solicited and unsolicited local and systemic adverse events (AEs) 3)All safety laboratory parameters (Haematology, serum chemistry and urinalysis) for any clinically significant changes. 4) Vital signsTimepoint: 1)During first 60 minutes post vaccination 2)During subsequent period of 7 days through subject diary and upto day 56 3)once at baseline and again at day 56. 4)once at baseline and again at each scheduled visit.

—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDrShalaka Aagarkhedkar

Biological E. Limited

kishore.tsa@biologicale.co.in040-30214046

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026