None listed
Conditions
Interventions
Intervention1: HBI Inactivated Hepatitis-A Vaccine: Two doses intramuscularly at six months interval.
From 19 to 49 years: 1.0 ml per dose
From 12 months to below 19 years: 0.5 ml per dose
Control Int
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of 12 months to 49 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 length of the trial. 4. Subject/LAR has understood and provided written Informed Consent. 5. Negative Urine Pregnancy test for female subjects who have attained menarche, prior to each dose of vaccination
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. Pregnancy, Lactation or unreliable contraception in female subjects. 6. Known or suspected primary or acquired disease of the immune system. 7. History of allergy immunotherapy or receiving immunosuppressive 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 â�¥ 38.0�°C (100.4oF) 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
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity Proportion of subjects achieving seroconversion and seroprotection in each group, four to six weeks after the second dose of vaccination with HBI Inactivated Hepatitis-A Vaccine. Timepoint: four to six weeks after the second dose of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroprotection and seroconversion rate in each arm of each group four to six weeks after the second dose of vaccination. Geometric mean titres of antibodies in each arm of each group four to six weeks after the second dose of vaccination. Solicited/unsolicited local and systemic adverse events after each dose of vaccination and during four to six weeks follow-up period in each arm of each group.Timepoint: four to six weeks after the second dose of vaccination | — |
Countries
India
Contacts
Public ContactDr S Sai Krishna
Human Biologicals Institute
Outcome results
None listed