Evidence map›Paper›PMID 29767739›Full record

Trial reportThe Journal of infectious diseases2018

Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries.

S M Garland, P Pitisuttithum, H Y S Ngan, C-H Cho, C-Y Lee, C-A Chen, Y C Yang, T-Y Chu, N-F Twu, R Samakoses and 24 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00543543 phase3completednot on this map

A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2016Enrolled14,840ConditionsCervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital WartsArmsComparator: GARDASIL, Experimental: V503
NCT00943722 phase3completednot on this map

A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2009 to 2021Enrolled3,074ConditionsCervical Cancers, Vulvar Cancer, Vaginal Cancer, Genital LesionsArmsV503
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 20 institutions in 9 countries.

S M GarlandWestern Pacific Regional HPV Labnet Reference Laboratory, Department of Infectious Disease and Microbiology, Royal Women's Hospital, Murdoch Children's Research Institute, Royal Children's Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia.
P PitisuttithumVaccine Trial Centre, Mahidol University, Salaya, Thailand.
H Y S NganDepartment of Obstetrics and Gynaecology, the University of Hong Kong, China.
C-H ChoDepartment of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu, South Korea.
C-Y LeeDepartment of Gynecology, Chang Gung Memorial Hospital, Chiayi Branch, Taipei.
C-A ChenDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei.
Y C YangMacKay Memorial Hospital, Taipei.
T-Y ChuTzu Chi Medical Center, Hualien.
N-F TwuDepartment of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei, Taiwan.
R SamakosesDepartment of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
Y TakeuchiFukui General Hospital, Japan.
T H CheungDepartment of Obstetric and Gynaecology, Chinese University of Hong Kong, China.
S C KimDivision of Gynecologic Oncology, Ewha Womans University Mokdong Hospital, School of Medicine Ewha Womans University, Seoul, South Korea.
L-M HuangDepartment of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
B-G KimDepartment of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Y-T KimDepartment of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asian Medical Center, Seoul, South Korea.
K-H KimDepartment of Pediatrics and Center for Vaccine Evaluation and Study, Ewha Womans University College of Medicine, Seoul, South Korea.
Y-S SongObstetrics and Gynecology, College of Medicine, Seoul National University, Seoul, South Korea.
S LalwaniBharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India.
J-H KangDepartment of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, the Catholic University of Korea, South Korea.
M SakamotoDepartment of Gynaecology, Sasaki Foundation Kyoundo Hospital and Department of Obstetrics and Gynaecology, School of Medicine, the Jikei University, Tokyo, Japan.
H-S RyuDepartment of Obstetrics and Gynecology, School of Medicine, Ajou University, Suwon, South Korea.
N BhatlaDepartment of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
H YoshikawaIbaraki Prefectural Central Hospital, Kasama, Ibaraki, Japan.
M C EllisonMerck & Co., Inc., Kenilworth, New Jersey.
S R HanMSD K.K., Tokyo, Japan.
E MoellerMerck & Co., Inc., Kenilworth, New Jersey.
S MurataMSD K.K., Tokyo, Japan.
M RitterMerck & Co., Inc., Kenilworth, New Jersey.
M SawataMSD K.K., Tokyo, Japan.
C ShieldsMerck & Co., Inc., Kenilworth, New Jersey.
A WaliaMerck & Co., Inc., Kenilworth, New Jersey.
G PerezMerck & Co., Inc., Kenilworth, New Jersey.
A LuxembourgMerck & Co., Inc., Kenilworth, New Jersey.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USMSD K.K. (Japan) · JPEwha Womans University · KRNational Taiwan University Hospital · TWAjou University · KRAll India Institute of Medical Sciences · INBharati Vidyapeeth Deemed University · INChiayi Chang Gung Memorial Hospital · TWChinese University of Hong Kong · CNHualien Tzu Chi Medical Center · TWIbaraki Prefectural Central Hospital · JPKeimyung University · KRMackay Memorial Hospital · TWMahidol University · THPhramongkutklao Hospital · THRoyal Women's Hospital · AUSamsung Medical Center · KRSasaki Institute · JPSeoul National University · KRSeoul St. Mary's Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, and Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 9-15 years; NCT00943722; Study 002). Methods: Participants (N = 2519) were vaccinated at day 1 and months 2 and 6. Gynecological samples (Study 001 only) and serum were collected for HPV DNA and antibody assessments, respectively. Injection-site and systemic adverse events (AEs) were monitored. Data were analyzed by country and vaccination group. Results: 9vHPV vaccine prevented HPV-31/33/45/52/58-related persistent infection with 90.4%-100% efficacy across included countries. At month 7, ≥97.9% of participants seroconverted for each HPV type. Injection-site AEs occurred in 77.7%-83.1% and 81.9%-87.5% of qHPV and 9vHPV vaccine recipients in Study 001, respectively, and 62.4%-85.7% of girls/boys in Study 002; most were mild to moderate. Conclusions: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Asian participants. Data support 9vHPV vaccination programs in Asia. Clinical Trials Registration: NCT00543543; NCT00943722.

Indexed as

AdolescentAdultAntibodies, ViralAsiaChildDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleGenitalia, FemaleHumansMalePapillomaviridaePapillomavirus InfectionsPapillomavirus VaccinesTreatment OutcomeYoung AdultAntibodies, ViralPapillomavirus Vaccines

Identifiers

PMID29767739
PMCPMC5989602
OpenAlexW2804190767

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.