None listed
Conditions
Interventions
Intervention1: LIVE MUMPS VACCINE, (SINGLE DOSE VIAL FORMULATION): Each full S.C. dose of the vaccine (0.5 ml) contains not less than 5000 CCID50 of Mumps virus.
Route of administration-The subjects
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male subjects aged between 18 and 45 years (including both). Subjectsâ?? weight within ï?±15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases. Ability to communicate effectively with study personnel. Willingness to adhere to the protocol requirements. Be able to give consent for participation in the trial. Normal health as determined by personal medical history, clinical examination and laboratory examinations data during screening (within the clinically acceptable range).
Exclusion criteria
Exclusion criteria: History of anaphylaxis or serious reactions to vaccines, egg proteins, gelatin or gelatin containing products. Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.). 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. Subjects who have received immunoglobulins parenterally during the preceding 3 months. Subjects who have received any vaccine in the preceding 6 months. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement. History or presence of significant alcoholism or drug abuse within the past one-year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products. Difficulty with donating blood. Blood pressure less than 100/60 mm Hg or more than 140/90 mm Hg. Pulse less than 60/minute or more than 110/minute. Febrile.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Mumps Vaccine (Live), Single dose of M/s. Cadila Healthcare Ltd., India given subcutaneously in healthy adult male human subjects under fasting condition.Timepoint: checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr R H Jani
Cadila Healthcare Limited
Outcome results
None listed