A clinical trial to see the immune response and safety of Varicella vaccine of VHB Life Sciences Limited Ltd with other marketed Varicella vaccine in children aged between 1 to 12 years.
- Conditions
- Active immunization for the prevention of disease caused by Varicella virus
- Registration Number
- CTRI/2022/07/044215
- Lead Sponsor
- VHB Life Sciences Limited
- Brief Summary
This study is a Randomized, open label, parallel group, active controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Varivax® [Varicella vaccine (Live Attenuated, Lyophilized I.P) of VHB Life Sciences Limited] compared to a marketed Varicella Vaccine in healthy paediatric subjects aged between 1 to 12 years.
- The primary outcome evaluates percentage of subjects who achieved positive seroconversion at the end of the study Day 29(+7) after vaccination.
- The secondary outcome evaluates Geometric mean titre of IgG antibodies to Varicella Zoster virus at the end of the study Day 29(+7) after vaccination.
- Safety will be assessed based on the frequency of Adverse Events from the time of injection till the end of study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- Male and female, paediatric subjects between 1 to 12 years of age at the time of vaccination.
- Cohort 1: Subjects between from 1 to < 6 years old.
- Healthy subjects as determined by investigator’s clinical examination and assessment of child’s medical history.
- The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, respects intervals between visits).
- Written informed consent /assent obtained from the subject and parent(s)/LAR(s) of the subject.
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- Subjects with a history of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin. 2. Subjects with a history of previous varicella infection or vaccination, or if they had been exposed to the disease within 30 days of trial commencement. 3. Subjects with an acute febrile illness at the time of randomization. 4. Any other vaccine administration within 30 days of initiation of the study or planned during the study period. 5. Subjects with a history of convulsions, seizures, other central nervous system diseases. 6. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination. 7. Any confirmed or suspected immunosuppressive or immune deficient condition, based on medical history and physical examination (no laboratory testing required). 8. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination. 9. Blood dyscrasia as, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. 10. Chronic administration (defined as 14 or more consecutive days) of immune suppressants, or other immune-modifying drugs within 6 months prior to the first vaccine dose or any planned administration of immune suppressive and immune-modifying drugs during the entire study.
- For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
- Inhaled and topical steroids are allowed. 11. Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned during the study period. 12. Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). 13. Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of subjects who achieved positive seroconversion at the end of the study. 29 Days
- Secondary Outcome Measures
Name Time Method Geometric mean titre of IgG antibodies to Varicella Zoster virus at the end of the study. 29 Days
Trial Locations
- Locations (10)
All India Institute of Medical Sciences Raipur
🇮🇳Raipur, CHHATTISGARH, India
College of Medicine and Sagore Dutta Hospital
🇮🇳Kolkata, WEST BENGAL, India
Government Medical College and Government General Hospital (Old RIMSGGH)
🇮🇳Srikakulam, ANDHRA PRADESH, India
Grant medical college & Sir J J Group of Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Institute of Child Health Hospital
🇮🇳Kolkata, WEST BENGAL, India
Mysore Medical College and Research Institute and Associated Hospitals,
🇮🇳Mysore, KARNATAKA, India
Panchsheel Hospital Pvt. Ltd
🇮🇳Delhi, DELHI, India
PCMC’s PGI Yashwantrao Chavan Memorial Hospital
🇮🇳Pune, MAHARASHTRA, India
Sant Dnyaneshwar Medical Education and Research Centre
🇮🇳Pune, MAHARASHTRA, India
W Pratiksha Hospital,
🇮🇳Gurgaon, HARYANA, India
All India Institute of Medical Sciences Raipur🇮🇳Raipur, CHHATTISGARH, IndiaDr Atul JindalPrincipal investigator8224014667dratuljindal@gmail.com