None listed
Conditions
Interventions
Intervention1: Hepatitis A antigen: 1 ml single intramuscular (I.M.) dose of the vaccine into the Upper arm.
Control Intervention1: NA: NA
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male and non-pregnant, non-lactating female subjects aged between 18 and 45 years (both inclusive). 2)Body weight > 50 kg for male and >45 kg for female and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive). 3)Ability to communicate effectively with study personnel. 4)Willingness to adhere to the protocol requirements. 5)Be able to give consent for participation in the trial. 6)Normal health as determined by personal medical history, clinical examination, and laboratory examinations data during screening (within the clinically acceptable range) during the study.
Exclusion criteria
Exclusion criteria: 1) History of anaphylaxis or serious reactions to any vaccines. 2) Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.). 3) Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive. 4) Subjects who have received immunoglobulins parenterally during the preceding 3 months. 5) Subjects who have received any vaccine in the preceding 6 months. 6) History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or gynecological any other body system involvement. 7) History or presence of significant alcoholism or drug abuse within the past one-year. 8) History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product. 9) Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg. 10) Pulse less than 60/minute or more than 100/minute. 11) History of fever in last 2 weeks 12) Any clinically significant ECG abnormalities. 13) Any clinically significant abnormal laboratory values during screening. 14) Any clinically significant chest X-Ray findings during screening. 15) Major illness during 3 months before the screening period. 16) Subjects who have participated in drug research studies within past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assess the safety and tolerability of inactivated Hepatitis A Vaccine (Adsorbed) I.P. of M/s. Cadila Healthcare LtdTimepoint: Day 0 (Pre-dose) and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Taufik Momin
Cadila Healthcare Limited
Outcome results
None listed