Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.
Timeline
- Start
- 2014-03-07
- Primary completion
- 2015-02-24
- Completion
- 2015-10-13
Outcome
Met primary endpoint
paper Six weeks Postdose 1, the response rate (percent of subjects with VZV antibody titer ≥5 gpELISA units/mL) of VARNSP was non-inferior compared to VAR. PMID 29087781 ↗
registry analysis (non-inferiority or equivalence test); VARIVAX™ New Seed Process + M-M-R II™ vs VARIVAX™ 2007 Process + M-M-R II™; p <0.001; Risk Difference (RD) 0.0 (95% CI -3.2 to 3.2) NCT02062502 ↗
registry analysis (non-inferiority or equivalence test); VARIVAX™ New Seed Process + M-M-R II™ vs VARIVAX™ 2007 Process + M-M-R II™; p <0.001; Risk Difference (RD) 0.95 (95% CI 0.85 to 1.06) NCT02062502 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VARNSP | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | varicella vaccine live | Vaccine | 0.5 ml | Subcutaneous |
| Background | M-M-R II | Vaccine | 0.5 ml | Subcutaneous |