1.Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years.
Byung Wook YOO ; Chang Oh KIM ; Allen IZU ; Ashwani Kumar ARORA ; Esther HEIJNEN
Infection and Chemotherapy 2018;50(4):301-310
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.
Adult
;
Fatigue
;
Humans
;
Influenza Vaccines*
;
Influenza, Human*
;
Korea
;
Mortality
;
Myalgia
;
Vaccination
2.Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years.
Byung Wook YOO ; Chang Oh KIM ; Allen IZU ; Ashwani Kumar ARORA ; Esther HEIJNEN
Infection and Chemotherapy 2018;50(4):301-310
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.
Adult
;
Fatigue
;
Humans
;
Influenza Vaccines*
;
Influenza, Human*
;
Korea
;
Mortality
;
Myalgia
;
Vaccination
3.Bipartite clavicular attachment of the sternocleidomastoid muscle: a case report.
Vandana MEHTA ; Jyoti ARORA ; Ashwani KUMAR ; Ashish Kumar NAYAR ; Hitendra Kumar IOH ; Vanita GUPTA ; Rajesh Kuamr SURI ; Gayatri RATH
Anatomy & Cell Biology 2012;45(1):66-69
Morphological variations of the sternocleidomastoid (SCM) muscle assume relevance during attempted surgical interventions in the cervical region. The present study reports bipartite clavicular attachment of the SCM in the neck of an adult male cadaver during performance of a routine anatomy demonstration. The anomaly was unilaterally observed on the left side of the neck. The clavicular head of the muscle exhibited two bellies, one medial and one lateral. While the medial belly was fused with the sternal head, the lateral belly appeared to blend with the medial. Cranially, the SCM attached to the mastoid process and superior nuchal line. We have attempted to elucidate the embryological basis of the above muscular variant. Additionally, we discuss its clinical relevance, highlighting the utility of the SCM in various reconstructive procedures. We assert that detailed anatomical knowledge of such SCM variants is of utility not only to the gross anatomist, but also for neck and orthopaedic surgeons and anaesthetists. Moreover, radiologists require familiarity with such aberrations to decipher magnetic resonance imaging scans of the cervical region.
Adult
;
Anatomists
;
Cadaver
;
Head
;
Humans
;
Magnetic Resonance Imaging
;
Male
;
Mastoid
;
Muscles
;
Neck
;
Recognition (Psychology)