Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants

Shinya Murata, Masayoshi Shirakawa, Yoshie Sugawara, Michiko Shuto, Miyuki Sawata, Yoshiyuki Tanaka, Shinya Murata, Masayoshi Shirakawa, Yoshie Sugawara, Michiko Shuto, Miyuki Sawata, Yoshiyuki Tanaka

Abstract

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.

Keywords: Clinical trial; Injection-site reaction; Japan; Post-hoc analysis; Quadrivalent human papillomavirus (4vHPV) vaccine; Safety.

Conflict of interest statement

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.

Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.

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Source: PubMed

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