None listed
Conditions
Interventions
Intervention1: Varicella vaccine: For age groups 1-12 years: A single dose (0.5mL) of vaccine at day 0.
For age groups 13-60 years: Two doses (0.5mL) of vaccine at day 0 and at day 42.
Varicella Vac
Manufactured
by Changchun BCHT Biotechnology Co. China.
Control Intervention1: VARIPED® Vaccine: For age groups 1-12 years: A single dose (0.5mL) at day 0.
For age groups 13-60 years: Two doses (0.
Sponsors
Novo Medi Sciences Pvt Ltd.
Clinical Research Network India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of either sex aged 1 year to 60 years. 2. Informed consent/assent of the subject/parents/LAR and their willingness to be followed up for entire study period. 3. Subject/Parents/LAR with adequate literacy to fill the subject diary cards. 4. Female participants of reproductive potential must: Have a negative urine pregnancy test prior to each study vaccination (on the day the participant is vaccinated and before vaccine is administered). Agree to remain abstinent, or use (or have their partner use) 2 acceptable methods of birth control. Abstinence or 2 acceptable methods of birth control must be practiced or used from the day of enrolment, throughout the duration of the study, and continued until 3 months following the last study vaccination. Age of subject should be at least 12 completed months
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, 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 a history of convulsions, seizures, other central nervous system diseases, severe disease of hematopoietic system, cardiovascular system, liver or kidney 4. Subjects with an acute febrile illness at the time of randomization 5. Any other vaccine administration within 30 days of initiation of the study or planned during the study period. 6. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy) 7. Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned. during the study period. 8. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination. #Close contact (family member or neighbour) with a diagnosed case of vericella infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Sero-conversion rate at 6 weeks post vaccination for children & at 6 weeks post dose 2 for adolescents/adults in test & reference arm. 2.Geometric mean titre of IgG antibodies to Varicella Zoster virus at 6 weeks postvaccination for children and at 6 weeks post dose 2 for adolescents/adults in test and reference arm. Timepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.4- Fold Seroconversion (antibody rise) rate at 6 weeks post vaccination for children & at 6 weeks post dose 2 for adolescents/adults in test and reference arm. 2.Geometric mean fold rise (GMFR) from day 0 (pre-vaccination) to 6 weeks post vaccination for children and to 6 weeks post dose 2 for adolescents/adults. Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Clinical Research Network India
Outcome results
None listed