Chickenpox Vaccine in Healthy Indian Adults and Adolescents

Phase 4

• Registration Number: CTRI/2017/09/009877
• Lead Sponsor: Dr Sheila Bhave

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: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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.

OR

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of two doses of live attenuated varicella (VR 795 Oka strain) vaccine in healthy Indian adults & adolescents as assessed by seroconversion and Anti VZV IgG antibody titers. <br/ ><br> <br/ ><br>Timepoint: 6 weeks after first dose and second dose of vaccination.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of two doses of live attenuated varicella vaccine (VR795 Oka strain) vaccine in healthy Indian adults & adolescents assessed using solicited and unsolicited adverse eventsTimepoint: 6 weeks after first dose and second dose of vaccination.