None listed
Conditions
Interventions
Intervention1: HEPATITIS A (LIVE) VACCINE (FREEZE-DRIED): Each subject will receive a single dose of 1.0 ml of vaccine of IP subcutaneously.
Control Intervention1: BIOVACTM - A (FREEZE-DRIED LIVE ATTE
Sponsors
Joint Force Pharmachem Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The subjects must meet all of the following criteria: 1. Healthy Indian children aged between of 18 months to less than or equal to 12 years of age. 2. Judged to be in good health on the basis of reported medical history, physical examination and clinical judgement of the investigator. 3. Plans to remain in the study area for the entire duration of the trial. 4. Participant/Parent/LAR has understood and provided written Informed Consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are seropositive for anti-HAV antibodies ( >20 mIU/ml). 2. Participation in any other clinical trial in the four weeks preceding the trial vaccination. 3. Planned participation in any other clinical trial during the present trial period. 4. Subjects who have a known history of allergy to any component of the vaccine. 5. Known history of allergies to any vaccination and high protein foods like eggs, milk and milk products 6. Known or suspected primary or acquired disease of the immune system. 7. History of allergy immunotherapy or receiving immuno-suppressive therapy. 8. Subjects on treatment with any hepatotoxic drug before receiving the vaccine during the last 90 days. 9. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction and autoimmune disease. 10. Known or suspected acute respiratory illness with active symptoms and signs including one or more of the following: rhinorrhea, cough, pharyngitis and respiratory problems (e.g., wheezing, shortness of breath). 11. Any fever with temperature = 38.0°C (100.4°F) in last 3 days. 12. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms. 13. Any known history or suspicion of thrombocytopenia or a bleeding disorder. 14. History or suspicion of HIV, Hepatitis A, Hepatitis B or Hepatitis C infection. 15. Any documented evidence of vaccination with Hepatitis A vaccine. 16. Any history of receipt of blood products or immunoglobulins in last 3 months 17. Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days. 18. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titres (GMT) between two treatment groupsTimepoint: 56 Days;Proportion of subjects achieving Seroprotection rate of Hepatitis A between two treatment groupsTimepoint: 56 Days | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving seroconversion rate (humoral immune response) between two treatment groupsTimepoint: 56 Days | — |
Countries
India
Contacts
Public ContactHitesh Thakur
Joint Force Pharmachem Pvt Ltd
Outcome results
None listed