A Clinical trial to evaluate and compare the efficacy and safety of inactivated Hepatitis A vaccine developed by Human Biologicals Institute with Havrix vaccine in healthy subjects

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2019
INTERVENTION: 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 Intervention1: Havrix® Vaccine manufactured by GlaxoSmithKline Biologicals: 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 CONDITION: Prevention of Hepatitis A infection PRIMARY OUTCOME: 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 OUTCOME: 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 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
Epistemonikos ID: 3e84248a118afff8039d4f1941116ad99eda6462
First added on: Dec 20, 2022