None listed
Conditions
Interventions
Intervention1: Hepatitis-A Vaccine.: Inactivated Hepatitis A vaccine is a liquid injection, packaged in vial or pre filled syringe, 1.0 ml per dose.
Intervention2: Inactivated Hepatitis A vaccine: (2
Sponsors
Prosper Channel Life Science India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults of 18-40 years of age who give written informed consent prior to the study entry. 2. Subjects with good health as determined by: • Medical history • Physical examination • Clinical judgment of the Investigator
Exclusion criteria
Exclusion criteria: Presence of jaundice or any abnormal function as indicated by elevated Alanine Aminotransferase (ALT) and/or HBsAg positive. 2. Subjects who are seropositive for Hepatitis A virus should be excluded (>=20 mIU/ml) 3. Subjects on treatment with any hepatotoxic drug before receiving the vaccine. 4. Fever > 38°C in past 3 days. 5. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days. 6. Subjects with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy within 1 month prior to study entry till completion (including systemic or inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation. 7. Subjects who have received any blood or blood products, cytotoxic agents or radiotherapy within last month. 8. Subjects with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component 9. Subjects with any serious chronic disease such as cardiac, renal, hematological, hepatic, respiratory disease or autoimmune disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives. 10. Subjects who have participated in another trial of an investigational agent within 30 days of enrolment. 11. Subjects who are planning to leave the area of the study site before the end of the study period. 12. Subjects who have received any live attenuated vaccines in past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome/Efficacy Variable: Immunogenicity 1 month after IInd dose vaccination (IInd dose of vaccination will be administered to subject after 6 months of Ist dose of vaccination). â?? Anti-Hepatitis A virus antibody concentrations. â?? Seroprotection status defined as anti-Hepatitis A antibody concentrations â?¥ 20 mIU/ml.Timepoint: Primary Outcome/Efficacy Variable: Immunogenicity 1 month after IInd dose vaccination (IInd dose of vaccination will be administered to subject after 6 months of Ist dose of vaccination). â?? Anti-Hepatitis A virus antibody concentrations. â?? Seroprotection status defined as anti-Hepatitis A antibody concentrations â?¥ 20 mIU/ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome/Efficacy Variable(s): â?? Occurrence of solicited local adverse events during the 7-day (Days 0, 1, 2, 3, 4, 5, 6, 7) follow up period after vaccination. â?? Occurrence of solicited general adverse events during the 7-day (Days 0, 1, 2, 3, 4, 5, 6, 7) follow up period after vaccination. â?? Occurrence of unsolicited local and general adverse events on follows up. â?? Occurrence of serious adverse events during the entire study period.Timepoint: 1. 7 days after 1st dose post vaccination. 2. 7 days after 2nd dose post vaccination. | — |
Countries
India
Contacts
Public ContactMr NC Sharma
Prosper Channel Life sceince India Pvt Ltd
Outcome results
None listed