PMID- 31634044
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20210621
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 16
IP  - 6
DP  - 2020 Jun 2
TI  - Results from a large post-marketing safety surveillance study in the Republic of 
      Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 
      2 months-55 years.
PG  - 1260-1267
LID - 10.1080/21645515.2019.1670125 [doi]
AB  - The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is approved in the 
      Republic of Korea for use in individuals from 2 months of age. This single-arm, 
      open-label, observational, multicenter, post-marketing study (NCT01766206) 
      assessed the safety of MenACWY-CRM vaccine administered according to local 
      clinical practice. A total of 3939 individuals aged 2 months-55 years provided 
      safety data post-vaccination; the analysis was conducted on the per-protocol set 
      (3920 participants). Solicited and unsolicited adverse events (AEs) were 
      collected over 7 days post-vaccination and medically-attended AEs (MAAEs) and 
      serious AEs (SAEs) over 29 days post-vaccination. Among recorded solicited AEs, 
      injection site AEs were reported by 21.38% of participants, with tenderness/pain 
      being most frequent across age groups; systemic AEs were reported in 13.95% of 
      participants, with irritability (in <6-year-olds), headache and myalgia (in >/=6 
      year-olds) being the most frequently reported. Most solicited AEs were mild or 
      moderate in nature. The percentage of participants reporting unsolicited AEs 
      varied in the study population, i.e. 12.56% in participants aged 2-23 months and 
      3.18% in those >/=2 years of age. Overall, less than 22% of unsolicited AEs were 
      considered as related to vaccination. MAAEs (10.89% of participants) were mostly 
      mild; 2.82% were considered as related to vaccination. Three (0.46%) and 5 
      (0.15%) SAEs (none vaccination-related) occurred in participants aged 2-23 months 
      and 2-55 years, respectively. No deaths were reported. The safety profile for 
      MenACWY-CRM in this post-marketing surveillance was consistent with observations 
      from studies conducted during the vaccine's clinical development, with no new 
      safety concerns.
FAU - Yoo, Byung Wook
AU  - Yoo BW
AUID- ORCID: 0000-0002-8753-9660
AD  - Department of Family Medicine, Soonchunhyang University Seoul Hospital , Seoul, 
      Republic of Korea.
FAU - Jung, Hye Lim
AU  - Jung HL
AUID- ORCID: 0000-0003-0601-510X
AD  - Department of Pediatrics, Sungkyunkwan University, Kangbuk Samsung Hospital , 
      Seoul, Seoul, Republic of Korea.
FAU - Byeon, Yoon Seob
AU  - Byeon YS
AD  - Department of Pediatrics, Moran Women's Hospital , Gyeongsangnam-do, Republic of 
      Korea.
FAU - Han, Dong Ki
AU  - Han DK
AD  - Pediatrics Clinic , Gyeongsangnam-do, Republic of Korea.
FAU - Jeong, Nak Yeong
AU  - Jeong NY
AD  - Department of Internal Medicine, Yonsei Koum Internal Medicine Clinic , Seoul, 
      Republic of Korea.
FAU - Curina, Carlo
AU  - Curina C
AUID- ORCID: 0000-0002-3536-124X
AD  - GSK , Siena, Italy.
FAU - Moraschini, Luca
AU  - Moraschini L
AD  - GSK , Siena, Italy.
FAU - Kim, Sung Jin
AU  - Kim SJ
AUID- ORCID: 0000-0001-5054-8048
AD  - GSK , Seoul, Republic of Korea.
FAU - Bhusal, Chiranjiwi
AU  - Bhusal C
AD  - GSK , Amsterdam, The Netherlands.
FAU - Pellegrini, Michele
AU  - Pellegrini M
AUID- ORCID: 0000-0001-8505-9260
AD  - GSK , Siena, Italy.
FAU - Miao, Yan
AU  - Miao Y
AD  - GSK , Amsterdam, The Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT01766206
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20191025
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Humans
MH  - Marketing
MH  - *Meningococcal Infections/epidemiology/prevention & control
MH  - *Meningococcal Vaccines/adverse effects
MH  - *Neisseria meningitidis
MH  - Republic of Korea
MH  - Vaccines, Conjugate/adverse effects
PMC - PMC7482729
OTO - NOTNLM
OT  - MenACWY-CRM
OT  - Republic of Korea
OT  - Safety surveillance
OT  - adolescents
OT  - adults
OT  - children
EDAT- 2019/10/22 06:00
MHDA- 2021/06/22 06:00
PMCR- 2019/10/25
CRDT- 2019/10/22 06:00
PHST- 2019/10/22 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2019/10/22 06:00 [entrez]
PHST- 2019/10/25 00:00 [pmc-release]
AID - 1670125 [pii]
AID - 10.1080/21645515.2019.1670125 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2020 Jun 2;16(6):1260-1267. doi: 
      10.1080/21645515.2019.1670125. Epub 2019 Oct 25.