None listed
Conditions
Interventions
Intervention1: BIOVAC VTM: BIOVAC VTM Varicella vaccine (live attenuated) I.P. Freeze dried 0.5ml/vial marketed by Wockhardt Limited, Mumbai containing Oka strain. After reconstitution each 0.5ml/dose
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects aged >= 12 months but 2.No clinical history of varicella (chicken pox) and herpes zoster natural infection in the past. 3.With an axillary temperature 4.No varicella vaccination history previously. 5.Parent or the legal guardian of the subject should provide written informed consent. 6.Parent or the legal guardian of the subject should agree to comply with all trial related instructions (maintain diary card, attend follow up visits)
Exclusion criteria
Exclusion criteria: 1.Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past. 2.History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination. 3.Presence of any person in close vicinity of the subject who is at high risk of developing varicella (like immunocompromised sibling) 4.Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc.) 5.Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months. 6.Any major congenital abnormality â?? cardiac, renal, neurological. 7.Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection. 8.History of encephalopathy, epilepsy and other nervous system disorders. 9.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. 10.History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc. 11.Febrile (axillary temperature > 37.5°C) or any systemic illness at the time of vaccination. 12.History of administration of Varicella zoster immune globulin or any blood products in the previous 4 weeks. 13.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. 14.Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks. 15.Participation in any other interventional clinical trial. 16.Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of immunogenicity of two doses of the vaccine by estimation of seroprotection rates, considering a cut-off of 5gpELISA or 10 mIU/ml of anti-Varicella (VZV) IgG antibody and the rise of geometric mean titer (GMT) from baseline values to four weeks after the 1st and 2nd dose vaccination respectively.Timepoint: Each enrolled subject shall be followed up to 12 months post vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of "Breakthrough" infections of varicella occurring post vaccination (from 42 days after 1st and 2nd dose of vaccine to study end i.e. up to 12 months). 2. Assessment of safety by monitoring for solicited and unsolicited vaccine related serious and non-serious adverse effects from first dose vaccination to 6 weeks of second dose post vaccination. Timepoint: Each enrolled subject shall be followed up to 12 months post vaccination | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Institute of Child Health,
Outcome results
None listed