Phase 1 clinical study to assess the safety and tolerability of Diphtheria and Tetanus vaccine

Phase 1

Completed

• Registration Number: CTRI/2014/01/004359
• Lead Sponsor: Cadila Healthecare 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 (including both).

· 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 to vaccines, aluminum or aluminum 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.

· 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.

Also subjects will be assessed for alcohol and drug of abuse consumption at the time of check in

during the study. Subjects who are found positive in alcohol breathe test and urine test for drug of

abuse, will not be enrolled in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified