Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years
Infection and Chemotherapy
;
: 301-310, 2018.
Article
in English
| WPRIM
| ID: wpr-721811
ABSTRACT
BACKGROUD Influenza vaccination is recommended for adults aged ≥65 years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as FLUAD® and VANTAFLU®, in South Korean subjects aged ≥65 years. MATERIALS AND METHODS:
Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29).RESULTS:
Of the 770 subjects enrolled (FLUAD®, n = 389; VANTAFLU®, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%).CONCLUSION:
These results show that the MF59-adjuvanted influenza vaccine known as FLUAD® or VANTAFLU® had acceptable safety profiles in older adults (aged ≥65 years) in South Korea.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Influenza Vaccines
/
Mortality
/
Vaccination
/
Influenza, Human
/
Fatigue
/
Myalgia
/
Korea
Type of study:
Controlled clinical trial
/
Prognostic study
/
Screening study
Limits:
Adult
/
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Infection and Chemotherapy
Year:
2018
Type:
Article
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