Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Hepatitis B vaccine (rDNA) I.P. of M/s Cadila Healthcare Ltd.: Subjects will receive three doses (1 ml each) of the vaccine on day 0, day 30 and day 60 respectively. The vaccine will be
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adult subjects of either gender between 20-50 years 2.Subjects willing to give written informed consent 3.Subjects literate enough to fill the diary card 4.Subjects negative for serological markers for Hepatitis B (HBsAg, anti-HBs and anti-HBc)
Exclusion criteria
Exclusion criteria: 1.History of known or suspected allergy to any of the vaccine components 2.History of Hepatitis B vaccination 3.History of Hepatitis B infection or carrier state 4.Known history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 5.Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 6.Clinically significant systemic disorder such as hepatic, cardiovascular, respiratory, neurologic, gastrointestinal, renal, endocrine, hematological or immunological disorder 7.History of any acute illness within the last 1 week 8.Subjects with febrile illness (temperature >=38 oC) at the time of presentation 9.Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 10.Any vaccine administration within the last 30 days 11.Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 12.Subjects with history of alcohol or drug abuse in the past one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with sero-protective levels of anti-HBs antibodies at the end of studyTimepoint: Day 90 (30 days after third dose of vaccine) | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of anti-HBs antibodies at baseline and at the end of studyTimepoint: Day 0 and Day 90 (30 days after third dose of vaccine);Proportion of subjects with anti-HBs antibody titre â?¥100 mIU/ml (high-responders) at the end of studyTimepoint: Day 90 (30 days after third dose of vaccine) | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Cadila Healthcare Ltd
Outcome results
None listed