PMID- 32783746
OWN - NLM
STAT- MEDLINE
DCOM- 20210623
LR  - 20221207
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 17
IP  - 3
DP  - 2021 Mar 4
TI  - Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 
      months and older.
PG  - 690-693
LID - 10.1080/21645515.2020.1795477 [doi]
AB  - Quadrivalent influenza vaccines (QIVs) provide protection against the two 
      influenza A viruses (H1N1 and H3N2) and both co-circulating influenza B lineages. 
      QIVs have been found safe, immunogenic, and efficacious in several phase III 
      clinical trials. Here we assess the safety of QIV after vaccination in Vietnamese 
      infants, children, and adults. Participants (n = 228) were asked to report any 
      solicited adverse events (AEs) occurring within 7 days, unsolicited non-serious 
      AEs occurring within 28 days post-vaccination, and serious adverse events (SAEs) 
      at any time during the study. The study was completed by 224 participants 
      (97.4%). Thirty-one children (39.7%) aged 6 - 35 months, 32 children (40.0%) aged 
      3 - 8 years, 2 participants (9.0%) aged 9 - 17 years, 5 participants (17.9%) aged 
      18 - 60 years, and 3 participants (15.0%) aged >/=60 years reported >/=1 solicited 
      reaction within 7 days following vaccination. The most frequent-solicited AEs 
      were injection-site tenderness or pain, appetite loss, fever, and abnormal crying 
      in 6 - 35 month-olds, and fever, headache, and myalgia in other age groups. No 
      severe-unsolicited AEs or vaccine-related SAEs were reported. These results 
      suggest that QIV is well tolerated across age groups in Vietnam, and can be 
      safely used to protect the Vietnamese population against influenza and its 
      potentially serious complications.
FAU - Thiem, Vu Dinh
AU  - Thiem VD
AD  - Center for Clinical Trials, National Institute of Hygiene and Epidemiology 
      (NIHE), Hanoi, Vietnam.
FAU - Chabanon, Anne-Laure
AU  - Chabanon AL
AD  - Sanofi Pasteur, Global Pharmacovigilance, Campus Sanofi Lyon, Lyon, France.
FAU - Fournier, Marion
AU  - Fournier M
AD  - Sanofi Pasteur, Medical Operations, Campus Sanofi Lyon, Lyon, France.
FAU - Lavis, Nathalie
AU  - Lavis N
AD  - Sanofi Pasteur, Medical Operations, Campus Sanofi Lyon, Lyon, France.
FAU - Quang, Nguyen Dang
AU  - Quang ND
AD  - Center for Clinical Trials, National Institute of Hygiene and Epidemiology 
      (NIHE), Hanoi, Vietnam.
FAU - Ha, Vu Hai
AU  - Ha VH
AD  - Center for Clinical Trials, National Institute of Hygiene and Epidemiology 
      (NIHE), Hanoi, Vietnam.
FAU - Sanicas, Melvin
AU  - Sanicas M
AD  - Sanofi Pasteur Medical Asia and JPAC, Sanofi-Aventis (Singapore) Pte. Ltd, 
      Singapore, Singapore.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200812
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adult
MH  - Antibodies, Viral
MH  - Asian People
MH  - Child
MH  - Healthy Volunteers
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Infant
MH  - *Influenza A Virus, H1N1 Subtype
MH  - Influenza A Virus, H3N2 Subtype
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Vaccines, Inactivated
MH  - Vietnam/epidemiology
PMC - PMC7993207
OTO - NOTNLM
OT  - Influenza vaccine
OT  - Vietnam
OT  - adverse event
OT  - adverse reaction
OT  - clinical trial
OT  - seasonal influenza
EDAT- 2020/08/14 06:00
MHDA- 2021/06/24 06:00
PMCR- 2020/08/12
CRDT- 2020/08/14 06:00
PHST- 2020/08/14 06:00 [pubmed]
PHST- 2021/06/24 06:00 [medline]
PHST- 2020/08/14 06:00 [entrez]
PHST- 2020/08/12 00:00 [pmc-release]
AID - 1795477 [pii]
AID - 10.1080/21645515.2020.1795477 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2021 Mar 4;17(3):690-693. doi: 
      10.1080/21645515.2020.1795477. Epub 2020 Aug 12.