None listed
Conditions
Interventions
Intervention1: HBI Inactivated Hepatitis A Vaccine: Group A (19 to 49 years): 1.0 ml single dose intramuscularly at the deltoid region
Group B (12 to 18 years): 0.5 ml single dose intramuscularly at t
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects from 19 to 49 years and 12 to 18 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 who has understood and provided written Informed Consent. 5. Negative Urine Pregnancy test for female subjects above 18 years of age prior to enrolment into the study.
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. Subject who has 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. 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 at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. wheezing, shortness of breath). 11. Any fever with temperature >= 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, HCV or Hepatitis B. 15. Any history of receipt of blood products in last 3 months. 16. 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. 17. 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 |
|---|---|
| Safety 1. Solicited/unsolicited local adverse events after a single dose vaccination and during four to six weeks follow-up period for each group. 2. Solicited/unsolicited systemic adverse events after a single dose vaccination and during four to six weeks follow-up period for each group. 3. Number of serious adverse events during the study period for each group. Secondary Objective: Percentage of seroconversion and seroprotection in each group four to six weeks after vaccination. Timepoint: 4-6 weeks after the vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroconversion and Seroprotection.Timepoint: 4-6 weeks after the vaccination | — |
Countries
India
Contacts
Public ContactDr S Sai Krishna
Indian Immunologicals limited
Outcome results
None listed