None listed
Conditions
Interventions
Intervention1: Varivax® [Varicella vaccine (Live Attenuated, Lyophilized I.P) of VHB Life Sciences Limited]: Inject s.c. 0.5 ml of the vaccine at the deltoid insertion area of the lateral upper arm as
Sponsors
VHB Life Sciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female, paediatric subjects between 1 to 12 years of age at the time of vaccination. Cohort 1: Subjects between from 1 to Cohort 2: Subjects between from 6 to12 years old. 2. Healthy subjects as determined by investigator’s clinical examination and assessment of child’s medical history. 3. 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). 4. Subjects with axillary temperatures = (37°C/98.6°F). 5. Written informed consent /assent obtained from the subject and parent(s)/LAR(s) of the subject
Exclusion criteria
Exclusion criteria: 1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects who achieved positive seroconversion at the end of the study.Timepoint: 29 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of IgG antibodies to Varicella Zoster virus at the end of the study.Timepoint: 29 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed