A Clinical study to evaluate the immune response and safety of double dose of live attenuated Chicken Pox vaccine among Indian children : 12 month follow up study

Phase 4

• Registration Number: CTRI/2016/11/007452
• Lead Sponsor: Wockhardt Ltd

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 305

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified