PMID- 38112061
OWN - NLM
STAT- MEDLINE
DCOM- 20231220
LR  - 20240104
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 19
IP  - 3
DP  - 2023 Dec 15
TI  - Post-marketing safety surveillance study of a 9-valent human papillomavirus 
      vaccine in individuals aged 16-26 years in Chongqing, China.
PG  - 2281700
LID - 10.1080/21645515.2023.2281700 [doi]
LID - 2281700
AB  - The safety of human papillomavirus (HPV) vaccines, one of the major challenges to 
      public vaccination, has been controversial. This study assessed the adverse 
      reactions of 9-valent HPV (9vHPV) vaccines. This open-label, observational, 
      multi-center, post-marketing study assessed the safety of 9vHPV administered 
      according to local clinical practice. All post-marketing adverse events (AEs) 
      reports received between December 2019 and November 2021 in Chongqing were 
      analyzed. A total of 1000 individuals aged 16-26 years provided safety data 
      post-vaccination; The most common AEs (60.1%) experienced by 9vHPV vaccine 
      recipients were vaccination-site AEs (pain, swelling, induration) and 
      non-vaccination-site AEs (dizzy, weak, fever). Vaccination-site AEs most were 
      mild-to-moderate in intensity. Discontinuations and HPV 9-related serious AEs 
      were rare (0.3% and 0.0%, respectively). Eight SAEs were reported during the 
      study but none were considered as related to the study vaccine. The 9vHPV vaccine 
      was generally well tolerated in subjects aged 16-26 years; Vaccination-site AEs 
      were more common with 9vHPV.
FAU - Zhang, Yuan-Yuan
AU  - Zhang YY
AD  - Expanded Program on Immunization, Chongqing Center for Disease Control and 
      Prevention, Chongqing, China.
FAU - Xu, Jia-Wei
AU  - Xu JW
AD  - Expanded Program on Immunization, Chongqing Center for Disease Control and 
      Prevention, Chongqing, China.
FAU - Liu, Yang
AU  - Liu Y
AD  - Expanded Program on Immunization, Chongqing Center for Disease Control and 
      Prevention, Chongqing, China.
FAU - Qiu, Wei
AU  - Qiu W
AD  - Expanded Program on Immunization, Chongqing Center for Disease Control and 
      Prevention, Chongqing, China.
FAU - Bai, Pei-Ning
AU  - Bai PN
AD  - Expanded Program on Immunization, Chongqing Center for Disease Control and 
      Prevention, Chongqing, China.
FAU - Zeng, Yi
AU  - Zeng Y
AD  - Expanded Program on Immunization, Chongqing Center for Disease Control and 
      Prevention, Chongqing, China.
FAU - Wang, Qing
AU  - Wang Q
AD  - Expanded Program on Immunization, Chongqing Center for Disease Control and 
      Prevention, Chongqing, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20231219
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Humans
MH  - China
MH  - Pain/etiology
MH  - *Papillomavirus Infections/epidemiology
MH  - *Papillomavirus Vaccines/adverse effects/therapeutic use
MH  - *Vaccination/adverse effects
MH  - *Product Surveillance, Postmarketing
MH  - Adolescent
MH  - Young Adult
MH  - Adult
PMC - PMC10760320
OTO - NOTNLM
OT  - 9-valent human papillomavirus vaccine
OT  - Human papillomavirus (HPV)
OT  - post-marketing
OT  - safety
COIS- No potential conflict of interest was reported by the author(s).
EDAT- 2023/12/19 06:41
MHDA- 2023/12/20 06:42
PMCR- 2023/12/19
CRDT- 2023/12/19 04:35
PHST- 2023/12/20 06:42 [medline]
PHST- 2023/12/19 06:41 [pubmed]
PHST- 2023/12/19 04:35 [entrez]
PHST- 2023/12/19 00:00 [pmc-release]
AID - 2281700 [pii]
AID - 10.1080/21645515.2023.2281700 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2023 Dec 15;19(3):2281700. doi: 
      10.1080/21645515.2023.2281700. Epub 2023 Dec 19.