None listed
Conditions
Interventions
Intervention1: Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain): Followâ??up subjects for immunogenicity and breakthrough infection of varicella after vaccination with live attenuated V
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: . Healthy children of either sex who received test varicella vaccination (VR 795 varicella Oka strain) as part of the Phase III clinical trial (WOC/VAC/VAR/CT-19-PRT) . Parent/guardian of subject willing to give written ICF and to comply to all study related procedures
Exclusion criteria
Exclusion criteria: . Subjects who have not received test varicella vaccine (VR 795 varicella Oka strain) as part of the Phase III clinical trial (WOC/VAC/VAR/CT-19-PRT) . Any other criteria considered by the Investigator not to be suitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment will be done for the immunogenicity and any breakthrough infection of varicella and incidence of Herpes-zoster infection within 2 years post-vaccination and at every year up to 5 years post vaccination.Timepoint: No timepoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the immunogenicity and if any breakthrough infections of varicella have occurred within 2 years post-vaccination and assess the incidence of Herpes-zoster infection.Timepoint: Any adverse events noted after the completion of the previous Phase III clinical trial will be assessed for causality. | — |
Countries
India
Contacts
Public ContactVaibhavi Kapatkar
Wockhardt Ltd.
Outcome results
None listed