Phase III study for evaluation of safety and efficacy of Varicella vaccine.

Phase 3

Completed

• Registration Number: CTRI/2013/05/003611
• Lead Sponsor: Wockhardt 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: 254

Inclusion Criteria

•Healthy children aged 12 months to 12 years of either sex who are baseline VZV IgG antibody negative

•Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures

Exclusion Criteria

•Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.

•History of Varicalla vaccination in the past.

•History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination

•Presence of any person in close vicinity of the vaccine who is at high risk of developing varicella (like immunocompromised sibling)

•Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc)

•Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months.

•Any major congenital abnormality â?? cardiac, renal, neurological

•Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection

•Participant on any dose of oral/parenteral steroids or inhalational steroids >800 mcg of beclomethasone (or its equivalent) in the last 3 months prior to vaccination.

•History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc.

•Febrile (axillary temperature > 37°C) or any systemic illness at the time of vaccination.

•History of administration of varicella zoster immune globulin or any blood products in the previous 4 weeks

•Subject has received any live vaccine in the last 4 weeks or any killed vaccine in the last 4 weeks prior to this scheduled vaccination.

•Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The immunogenicity profile of the test will be evaluated and compared with that of the reference (Varilrix) vaccine in the study population by estimation of the: <br/ ><br>a)Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml) <br/ ><br>b)Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination <br/ ><br>Timepoint: a. Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml) <br/ ><br>b. Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
The safety of the vaccine in the study population will be evaluated by estimation of incidence of both serious and non-serious adverse events upto 6 weeks post vaccination with an intensive initial monitoring phase of 10 days post vaccinationTimepoint: estimation of incidence of both serious and non-serious adverse events