Evidence map›Paper›PMID 28591778›Full record

Trial reportThe Journal of infectious diseases2017

Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9-14 Years: A Randomized Trial.

Li-Min Huang, Thanyawee Puthanakit, Chiu Cheng-Hsun, Tang Ren-Bin, Tino Schwarz, Angelo Pellegrino, Susanna Esposito, Louise Frenette, Shelly McNeil, Paolo Durando and 15 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01381575 (Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT01381575 phase3completednot on this map

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2014Enrolled1,447ConditionsInfections, PapillomavirusArmsGSK Biologicals' HPV vaccine 580299
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Observational
  9. Article
  10. Review
  11. Rationalizing the HPV vaccination schedule: A long road to a worthwhile destination.Papillomavirus research (Amsterdam, Netherlands) · 2019
    Article
  12. Article
  13. Article
  14. Review
  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 17 institutions in 6 countries.

Li-Min HuangDepartment of Pediatrics, National Taiwan University Children's Hospital, National Taiwan University, Taipei.
Thanyawee PuthanakitDivision of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, and Research Unit in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Thailand.
Chiu Cheng-HsunDepartment of Pediatrics, Chang Gung Children's Hospital, Chang Gung University, Taoyuan.
Tang Ren-BinDepartment of Pediatrics, Cheng Hsin General Hospital, Taipei, Taiwan.
Tino SchwarzCentral Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg.
Angelo PellegrinoDepartment Distretto di Dronero, Azienda Sanitaria Locale Cuneo 1, Cuneo.
Susanna EspositoPediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca' GrandaOspedale Maggiore Policlinico, Milan.
Louise FrenetteQ&T Research Incorporated, Sherbrooke.
Shelly McNeilCanadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax.
Paolo DurandoDepartment of Health Sciences, University of Genoa and IRCCS AOU San Martino-IST, Genoa.
Paul RheaultMedicor Research Inc, Sudbury.
Carlo GiaquintoDepartment of Women's and Children's Health, University of Padova, Padua, Italy.
Michael HornSchoenau am Koenigssee.
Karl Ulrich PetryDepartment of Gynaecology and Obstetrics, Klinikum Wolfsburg, Wolfsburg.
Klaus PetersFacharzt für Frauenheilkunde und Geburtshilfe, Hamburg.
Toma AzharManna Research, Toronto, Canada.
Peter HillemannsMedizinische Hochschule Hannover, Hannover, Germany.
Stephanie De SimoniGSK.
Damien FrielGSK.
Suryakiran PemmarajuGSK, Bangalore, India.
Marjan HezarehChiltern International for GSK, Wavre, Belgium.
Florence ThomasGSK.
Dominique DescampsGSK.
Nicolas FolschweillerGSK.
Frank StruyfGSK.
Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo · ITCapital District Health Authority · CAChang Gung Children's Hospital · TWCheng Hsin General Hospital · TWChulalongkorn University · THFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITFraunhofer Project Centre Wolfsburg · DEGlaxoSmithKline (India) · INKlinik für Frauenheilkunde · DEKlinikum Würzburg Mitte · DEManna Research · CAMedizinische Hochschule Hannover · DENational Taiwan University Hospital · TWNomor Research (Germany) · DEOspedale Policlinico San Martino · ITQ & T Research · CAUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: We previously reported the noninferiority 1 month after the last dose of 2-dose human papillomavirus 16/18 AS04-adjuvanted (AS04-HPV-16/18) vaccine schedules at months 0 and 6 (2D_M0,6) and months 0 and 12 (2D_M0,12) in girls aged 9-14 years compared with a 3-dose schedule at months 0, 1, and 6 (3D_M0,1,6) in women aged 15-25 years. Here, we report the results at study end (month 36 [M36]). Methods: Girls were randomized 1:1 and received 2 vaccine doses either 6 months (2D_M0,6) or 12 months apart (2D_M0,12); women received 3 doses at months 0, 1, and 6 (3D_M0,1,6). Endpoints included noninferiority of HPV-16/18 antibodies for 2D_M0,6 versus 3D_M0,1,6; 2D_M0,12 versus 3D_M0,1,6; and 2D_M0,12 versus 2D_M0,6; and assessment of neutralizing antibodies, T cells, B cells, and safety. Results: At M36, the 2D_M0,6 and 2D_M0,12 schedules remained noninferior to the 3D_M0,1,6 schedule in terms of seroconversion rates and 3D/2D geometric mean titers for anti-HPV-16 and anti-HPV-18. All schedules elicited sustained immune responses up to M36. Conclusions: Both 2-dose schedules in young girls remained noninferior to the 3-dose schedule in women up to study conclusion at M36. The AS04-HPV-16/18 vaccine administered as a 2-dose schedule was immunogenic and well tolerated in young girls.

Indexed as

AdolescentAluminum HydroxideAntibodies, ViralChildFemaleHuman papillomavirus 16Human papillomavirus 18HumansLipid APapillomavirus VaccinesAluminum HydroxideAntibodies, ViralASO4 mixturehuman papillomavirus vaccine, L1 type 16, 18Lipid APapillomavirus Vaccines2-dose scheduleCervarixcervical cancerhuman papillomavirus (HPV)

Identifiers

PMID28591778
PMCPMC5853959
OpenAlexW2621690248

What OpenQuestion holds

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LicenceCC BY
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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.