Evaluate immune response of healthy children to BIOVAC-A Hepatitis A Vaccine

Phase 3

• Registration Number: CTRI/2012/07/002757
• Lead Sponsor: Wockhardt Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

1. Healthy children of either sex between the age range of 1-12 years.

2. Subjects at baseline with negative HAV antibodies (Anti HAV antibodies level £ 20

mIU/mL)

3. Subjects whose parents/guardians are willing to give written â??Informed Consent Form.â??

Exclusion Criteria

1. Known hypersensitivity to the vaccine or any component of the vaccine.

2. Previous history of Hepatitis A infection and subsequent jaundice manifested due to the infection.

3. Subjects who have earlier received even a single dose of hepatitis A vaccine.

4. Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease.

5. Subjects suffering from acute febrile illness.

6. Subjects with a present or past history of allergic reactions.

7. Subjects with clinically significant abnormal hematological and/or biochemical investigations.

8. Subjects who have participated in an investigational study within the past 2 weeks.

9. Subjects currently receiving immunosuppressant drugs.

10. Subjects whose parents/guardians are unwilling to give written â??Informed Consent Formâ??.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity (antibody titre more than or equal to 20mIU/mL)Timepoint: Baseline visit and end-of-treatment visit

Secondary Outcome Measures

Name	Time	Method
SafetyTimepoint: Baseline, Visit 2 and End-of-treatment visit