None listed
Conditions
Interventions
Intervention1: BIOVAC-A Vaccine: Freeze dried, live attenuated Hepatitis-A Vaccine subcutaneous injection.
Vaccination will be one time
Control Intervention1: Not applicable: Not applicable
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
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
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??.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity (antibody titre more than or equal to 20mIU/mL)Timepoint: Baseline visit and end-of-treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: Baseline, Visit 2 and End-of-treatment visit | — |
Countries
India
Contacts
Public ContactDr Ganesh Kadhe
KEM Hospital and Research Centre
Outcome results
None listed