None listed
Conditions
Interventions
Intervention1: Bivalent Human Papillomavirus (Types 16 L1 & 18 L1) Vaccine: Dosage :-0.5 ml of the vaccine into the Upper arm
Route:-Intramuscular Frequency:-Single dose
Control Intervention1: NA: NA
Sponsors
Cadila Healthcare limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Female subjects aged between 18 and 45 years (both inclusive). 2)Subjectsâ?? weight within +/-15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases. 3)No history of pregnancy or lactation in the past 3 months. 4)Fertile female volunteers protected against pregnancy by adequate long-term anti-fertility measures (oral or injectable hormonal contraceptives, Intrauterine contraceptive device, or surgical sterilization along with barrier method). 5)Ability to communicate effectively with study personnel. 6)Willingness to adhere to the protocol requirements. 7)Be able to give consent for participation in the trial. 8)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: 1)History of pregnancy or lactation in the past 3 months. 2)Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures (oral or injectable hormonal contraceptives, Intrauterine contraceptive device, or surgical sterilization along with barrier method). 3)History of less than 1 year of menopause and not using adequate long-term anti-fertility measures. 4)Using Hormone replacement therapy. 5)Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial. 6)Positive urine pregnancy testor serum β-hCG level on the day of screening or on the day of check-in. 7)History of anaphylaxis or serious reactions to vaccines, egg proteins, neomycin, gelatin or gelatin containing product. 8)Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.). 9)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. 10)Subjects who have received immunoglobulinsparenterally during the preceding 3 months. 11)Subjects who have received any vaccine in the preceding 6 months. 12)History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement. 13)History or presence of significant alcoholism or drug abuse within the past one-year. 14)History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product. 15)Difficulty with donating blood. 16)Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg. 17)Pulse less than 60/minute or more than 110/minute. 18)Febrile. 19)Any ECG abnormalities. 20)Any clinically significant abnormal laboratory values during screening. 21)Any clinically significant chest X-Ray findings during screening. 22)Major illness during 3 months before the screening period. 23)Subjects who have participated in drug research studies within past 3 months. 24)Subjects who have donated one unit (350ml) of blood in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Bivalent Human Papillomavirus (Types 16 L1 &18 L1) of M/s. Cadila Healthcare Ltd., India given intramuscular in healthy adult female human subjects.Timepoint: Vital signs :-check-in, prior to administration of dose, 1.00, 2.00, 6.00, and 12.00 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.Laboratory assessments :-screening. Hematology, liver function and renal function tests will also be done on Day 42. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Devang Parikh
Zydus Research Centre
Outcome results
None listed