None listed
Conditions
Interventions
Intervention1: Single dose Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain)of Wockhardt Limited: Live attenuated Varicella Vaccine VR 795 Varicella Oka strain. Single dose of 0.5 ml of
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 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) b) Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination 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) b. Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactSeema Bawangade
Outcome results
None listed