PMID- 32827835
OWN - NLM
STAT- MEDLINE
DCOM- 20210827
LR  - 20210827
IS  - 2405-8521 (Electronic)
IS  - 2405-8521 (Linking)
VI  - 10
DP  - 2020 Dec
TI  - Post-hoc analysis of injection-site reactions following vaccination with 
      quadrivalent human papillomavirus vaccine in Japanese female clinical trial 
      participants.
PG  - 100205
LID - S2405-8521(20)30004-5 [pii]
LID - 10.1016/j.pvr.2020.100205 [doi]
LID - 100205
AB  - AIM: The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated 
      efficacy and immunogenicity and was generally well tolerated in clinical trials 
      conducted in Japan. We report a detailed safety analysis of injection-site 
      reactions in female Japanese 4vHPV clinical trial participants. METHODS: This 
      post-hoc analysis included data from 2 double-blind, placebo-controlled phase II 
      clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in 
      Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 
      years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) 
      were monitored using vaccination report cards for 15 days after each vaccine 
      dose; serious AEs were reported throughout the trials. Post-hoc analyses of data 
      from these trials were performed to examine details of injection-site AEs, 
      including day of onset, time from onset to resolution, and maximum intensity. 
      RESULTS: Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients 
      and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and 
      swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site 
      AEs had an onset within 3 days of vaccination and were mild to moderate in 
      intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% 
      overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 
      92.7%) resolved within 5 days of onset. CONCLUSIONS: Most injection-site 
      reactions are mild or moderate in intensity and of short duration. The 3-dose 
      regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial 
      participants based on this post-hoc analysis. These results will further support 
      safety communication between healthcare providers and vaccine recipients 
      regarding the HPV vaccine. TRIAL REGISTRATION: Clinicaltrials. gov: NCT00378560 
      and NCT00411749.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Murata, Shinya
AU  - Murata S
AD  - MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic 
      address: shinya.murata@merck.com.
FAU - Shirakawa, Masayoshi
AU  - Shirakawa M
AD  - MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic 
      address: masayoshi.shirakawa@merck.com.
FAU - Sugawara, Yoshie
AU  - Sugawara Y
AD  - MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic 
      address: yoshie.sugawara@merck.com.
FAU - Shuto, Michiko
AU  - Shuto M
AD  - MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic 
      address: michiko.shutou@merck.com.
FAU - Sawata, Miyuki
AU  - Sawata M
AD  - MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic 
      address: miyuki.sawata@merck.com.
FAU - Tanaka, Yoshiyuki
AU  - Tanaka Y
AD  - MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic 
      address: yoshiyuki.tanaka@merck.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT00378560
SI  - ClinicalTrials.gov/NCT00411749
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200819
PL  - Netherlands
TA  - Papillomavirus Res
JT  - Papillomavirus research (Amsterdam, Netherlands)
JID - 101662552
RN  - 0 (Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Alphapapillomavirus/immunology
MH  - Double-Blind Method
MH  - Female
MH  - Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 
      18/*administration & dosage/adverse effects
MH  - Humans
MH  - Injection Site Reaction/*etiology
MH  - Injections, Intramuscular/*adverse effects
MH  - Japan
MH  - Papillomavirus Infections/*prevention & control
MH  - Vaccination/*adverse effects
MH  - Young Adult
PMC - PMC7472855
OTO - NOTNLM
OT  - Clinical trial
OT  - Injection-site reaction
OT  - Japan
OT  - Post-hoc analysis
OT  - Quadrivalent human papillomavirus (4vHPV) vaccine
OT  - Safety
COIS- The authors declare the following financial interests/personal relationships 
      which may be considered as potential competing interests: All authors are 
      employees of MSD K.K., Tokyo, Japan and may own stock or stock options in Merck & 
      Co., Inc., Kenilworth, NJ, USA.
EDAT- 2020/08/23 06:00
MHDA- 2021/08/28 06:00
PMCR- 2020/08/19
CRDT- 2020/08/23 06:00
PHST- 2019/11/29 00:00 [received]
PHST- 2020/08/13 00:00 [revised]
PHST- 2020/08/13 00:00 [accepted]
PHST- 2020/08/23 06:00 [pubmed]
PHST- 2021/08/28 06:00 [medline]
PHST- 2020/08/23 06:00 [entrez]
PHST- 2020/08/19 00:00 [pmc-release]
AID - S2405-8521(20)30004-5 [pii]
AID - 100205 [pii]
AID - 10.1016/j.pvr.2020.100205 [doi]
PST - ppublish
SO  - Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 
      Aug 19.