Phase 4
Completed N=767
A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
Source: ClinicalTrials.gov NCT01222403 ↗Enrolled (actual)
767
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. — 134; 122; 74; 72 participants
Summary
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. |
134; 122; 74; 72; 14; 21 | — |
| PRIMARY Number of Subjects Reporting Unsolicited AEs After Vaccination. |
15; 18; 3; 1 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females aged 65 years and above on the day of enrollment, who were eligible for seasonal influenza vaccination.
- In the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedures.
Exclusion Criteria
- History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein.
- Receipt of another (inactivated) vaccine within 2 weeks, or receipt of a live vaccine within 4 weeks prior to Study Day 1, or planning to receive some other vaccination before the final study visit (about Day 29 after vaccination).
- Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.
Data sourced from ClinicalTrials.gov (NCT01222403). 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.