CTRI/2017/09/009877OtherPhase 4
A Prospective, Single Arm, Open Label, Single Center study to evaluate the Immunogenicity and Safety of Two Doses of Live Attenuated Varicella Vaccine (VR 795 Oka Strain) in Healthy Indian Adults and Adolescents
Dr Sheila Bhave0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Other
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Indian adults and adolescents aged >12 years, of either gender
- •2.Subjects who are healthy or subject with medical disorder who are clinically stable without any known contraindication for varicella vaccination
- •3.Subjects with no clinical history of natural infection with varicella (chicken pox) and/or herpes zoster in the past
- •4.Adults (>= 18 years) who agree to comply with trial requirements and are willing to provide written informed consent.
- •Adolescents ( >12 years but < 18 years) who agree to comply with trial requirements and are willing to provide assent and written informed consent by their Parent/Legal guardians.
Exclusion Criteria
- •1.Clinical history of administration of varicella zoster vaccine or Anti VZV immune globulin or any blood products in the previous 6 months
- •2.History of exposure to varicella / herpes zoster infection in close contacts in past 4 weeks
- •3.Subjects who have received any live/ killed vaccine in past 4 weeks or are scheduled for receiving any live/ killed vaccine in next 4 weeks
- •4.Subjects who are pregnant or planning to get pregnant in next 3 months and unwilling to practice any contraception.
- •5.Subjects (adolescents <18 years of age) suffering from co-morbid conditions requiring salicylate therapy.
- •6.History of hypersensitivity to vaccine or vaccine formulation component like Neomycin / Kanamycin / etc.
- •7.Subjects suffering from acute febrile illness or infective clinical condition at time of vaccination
- •8.History of any congenital / primary / acquired immunodeficiency disorders (viz. innate immunity disorders / HIV ) or any hematological dyscrasias or neoplasms (viz. leukemia, lymphoma, etc.) affecting bone marrow
- •9.Subjects who have received high corticosteroids (equivalent to prednisolone 20mg daily for more than 2 weeks) or any immunosuppressive therapy in last 3 months
- •10.Subjects requiring or those who have received Cancer chemotherapy / Radiation in preceding 3 months.
- •11.Subjects in close contact with susceptible individuals like children, pregnant females or family members with congenital / acquired immunodeficiency or immunosuppressive therapy) or possibility of close contact with such susceptible individuals in next 6 weeks.
- •12.Subjects with history of / laboratory evidence of any systemic chronic disorders (Tuberculosis/ respiratory/ cardiovascular/ metabolic/ Neurological/ Neoplastic/ etc.)
- •13.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Investigators
Similar Trials
Completed
Phase 4
A Clinical Study to Evaluate the Safety and Efficacy of Divyaratan oil in patients with Headache, Mental Tension and Fatigue.CTRI/2023/06/054469Aryanveda Cosmeceuticals30
Completed
Phase 4
A clinical study to evaluate the safety and efficacy of Nimson coconut jasmine oil with Vitamin E in improving hair growthCTRI/2023/06/054302Aryanveda Cosmeceuticals30
Completed
Phase 4
A Clinical Study to Evaluate the Safety and Efficacy of Nimson Almond oil in patients with Dandruff and Hairfall control.CTRI/2023/06/054425Aryanveda Cosmeceuticals30
Completed
Phase 4
A Clinical Study to Evaluate the Safety and Efficacy of Red Onion oil in Patients with Dandruff and Hairfall.CTRI/2023/06/054294Aryanveda Cosmeceuticals30
Active, not recruiting
Phase 4
Effects of Pidotimod 400mg for repeated attacks of Respiratory Tract Infections in childreCTRI/2018/02/011898Dr K Nagaraju