N/A
Completed N=754
Re-examination Study For Varivax (V210-059 AM2)
Source: ClinicalTrials.gov NCT01062061 ↗Enrolled (actual)
754
Serious AEs
0.5%
Results posted
Jul 2013
Primary outcomePrimary: Percentage of Participants With One or More Adverse Events (AEs) — 37.69 Percentage of Participants
Summary
This survey is conducted for preparing application materials for re-examination under the Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of VARIVAX through collecting the safety information according to the Re-examination Regulation for New Drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With One or More Adverse Events (AEs) |
37.69 | — |
| PRIMARY Percentage of Participants With One or More AEs by Gender |
37.63; 37.75 | 0.9733 |
| PRIMARY Percentage of Participants With One or More AEs by Age |
36.01; 65.85 | 0.0001 sig |
| PRIMARY Percentage of Participants With One or More Adverse Drug Reactions (ADRs) |
3.30 | — |
| PRIMARY Percentage of Participants With One or More Unexpected AEs |
26.00 | — |
| PRIMARY Percentage of Participants With One or More Unexpected ADRs |
0.14 | — |
| PRIMARY Percentage of Participants With One or More Serious Adverse Events (SAEs) |
0.55 | — |
| PRIMARY Percentage of Participants With One or More Serious ADRs |
— | — |
| PRIMARY Percentage of Participants With One or More Unexpected SAEs |
0.28 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must be vaccinated with VARIVAX as a standard of care
Exclusion Criteria
- Participants who have been previously vaccinated with VARIVAX
- Contraindication with VARIVAX
Data sourced from ClinicalTrials.gov (NCT01062061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.