CTRI/2016/11/007452
Not yet recruiting
Phase 4
Evaluation of Immunogenicity, safety and breakthrough infection of 2-doses of Live Attenuated Varicella Vaccine in Indian Children: 12 months follow up study
Wockhardt Ltd0 sites305 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Wockhardt Ltd
- Enrollment
- 305
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects aged \>\= 12 months but \<\=12 years of either sex.
- •2\.No clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
- •3\.With an axillary temperature \<\=37\.5°C at the time of vaccination
- •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
- •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.
Outcomes
Primary Outcomes
Not specified
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