Possibia

3114943

Last Update Posted: 2019-05-08

Recruiting has ended

All Genders

accepted

12 months-12 Years

516 Estimated Participants

No Expanded Access

Interventional Study

Accepts healthy volunteers

Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to varivax which are indicated for active immunization for the prevention of varicella. Total of 488 subjects of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of four visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1 and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 2*, Visit 3 and Visit 4* (* telephone contact)

Eligibility

Relevant conditions:

Varicella

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

No valid contacts available

Data sourced from ClinicalTrials.gov