To assess the safety and tolerability of Hepatitis B vaccine in healthy , adult, male, Human subjects.

Phase 1

Completed

• Registration Number: CTRI/2015/06/005908
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

•Male subjects aged between 18 and 45 years (both inclusive).

•Subjectsâ?? weight within +/-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

•History of anaphylaxis or serious reactions after previous dose of any hepatitis B containing vaccines or to any other component of the vaccine, including yeast.

•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 product.

•Difficulty with donating blood.

•Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.

•Pulse less than 60/minute or more than 110/minute.

•Febrile.

•Any ECG abnormalities.

•Any clinically significant abnormal laboratory values during screening.

•Any clinically significant chest X-Ray findings during screening.

•Major illness during 3 months before the screening period.

•Subjects who have participated in drug research studies within past 3 months.

•Subjects who have donated one unit (350ml) of blood in the past 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of Hepatitis B Vaccine (rDNA) I.P. of M/s. Cadila Healthcare Ltd., India given intramuscularly in healthy adult male human subjectsTimepoint: Vital signs :-check-in, prior to administration of dose, 1, 2, 6, and 12 hours after administration of dose, at checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42.Respiratory Rate:-check-in, checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42.Clinical examination:- check-in, checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42.ECG:-screening.Lab assessments :- screening.Hematology,LFT and RFT tests:- Day 21.Urine test for drug of abuse and alcohol breath test:- check in. <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
ATimepoint: NA