None listed
Conditions
Interventions
Intervention1: Diphtheria, Tetanus,
Pertussis (whole cell) and Haemophilus type b conjugate vaccine,
single dose of M/s. Cadila Healthcare Ltd.: Route : Into the Upper arm Intramuscularly (I.M.).
Dose
Sponsors
Cadila Healthcare Ltd Ahmedabad India
Eligibility
Inclusion criteria
Inclusion criteria: · 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Diphtheria, Tetanus, Pertussis (whole cell) and Haemophilus type b conjugate vaccineTimepoint: Vital signs like oral temperature, sitting blood pressure and radial pulse - at check-in, prior to administration of dose, 1.00, 2.00, 6.00, and 12.00 hours after administration of dose and at check-out. Clinical examination of the subjects - at time of check-in, checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42 during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Kevinkumar Kansagra
Zydus Research Centre
Outcome results
None listed