Evidence map›Paper›PMID 31268383›Full record

Trial reportHuman vaccines & immunotherapeutics2019

A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years.

Tino F Schwarz, Li-Min Huang, Alejandra Valencia, Falko Panzer, Cheng-Hsun Chiu, Annabelle Decreux, Sylviane Poncelet, Naveen Karkada, Nicolas Folschweiller, Lan Lin and 2 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT00196924 phase3completednot on this map

Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Month Schedule in Healthy Female Subjects (10 - 14 Years)

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2006Enrolled2,067ConditionsInfections, PapillomavirusArmsHPV-16/18 L1/AS04
NCT00316706 phase3completednot on this map

A Long-term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013

TypeinterventionalSponsorGlaxoSmithKlineRan2005 to 2009Enrolled1,245ConditionsCervical Intraepithelial Neoplasia, Papillomavirus InfectionArmsGSK Biologicals' HPV-16/18 Vaccine (Cervarix™), Havrix™
NCT00877877 phase3completednot on this map

Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2015Enrolled632ConditionsInfections, Papillomavirus, Papillomavirus VaccinesArmsBlood sampling
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
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  19. Updates on HPV Vaccination.Diagnostics (Basel, Switzerland) · 2023
    Review
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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

12 authors at 7 institutions in 5 countries.

Tino F Schwarza Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital , Würzburg , Germany.ORCID 0000-0003-1505-1823
Li-Min Huangb Department of Pediatrics, National Taiwan University Hospital , Taipei , Taiwan.
Alejandra Valenciac Department of Pediatrics, Fundación de Santa Fe de Bogotá , Bogota , Colombia.
Falko Panzerd Practice for Pediatric and Adolescent Medicine , Mannheim , Germany.ORCID 0000-0002-3254-3881
Cheng-Hsun Chiue Department of Pediatrics, Chang Gung Memorial Hospital, Chang Gung University College of Medicine , Taoyuan , Taiwan.
Annabelle Decreuxf GSK , Wavre/Rixensart , Belgium.
Sylviane Ponceletf GSK , Wavre/Rixensart , Belgium.ORCID 0000-0002-2279-5444
Naveen Karkadaf GSK , Wavre/Rixensart , Belgium.ORCID 0000-0002-7543-1345
Nicolas Folschweillerf GSK , Wavre/Rixensart , Belgium.ORCID 0000-0003-0299-7783
Lan Linf GSK , Wavre/Rixensart , Belgium.ORCID 0000-0001-6604-918X
Gary Dubing GSK , King of Prussia , PA , USA.
Frank Struyff GSK , Wavre/Rixensart , Belgium.ORCID 0000-0001-9988-0260
GlaxoSmithKline (Belgium) · BEChang Gung University · TWFundación Santa Fe de Bogotá · COGerman Center for Pediatric and Adolescent Rheumatology · DEKlinikum Würzburg Mitte · DENational Taiwan University Hospital · TWTakeda (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study assessed long-term immunogenicity and safety following 3 doses of AS04-adjuvanted human papillomavirus (HPV)-16/18 L1 virus-like particle (VLP) vaccine in females 10-14 years old. Girls included in the immunogenicity subset in the primary controlled, observer-blinded, randomized study (NCT00196924) who received 3 doses were invited for a 10-year follow-up (NCT00316706 and NCT00877877). Serum antibody responses against HPV-16/18 (vaccine types) and HPV-31/45 (non-vaccine types) were measured by enzyme-linked immunosorbent assay (ELISA) using type-specific VLP as coating antigens. Serious adverse events (SAEs) and pregnancy information were recorded. At Month (M) 120, all subjects (N = 418, according-to-protocol immunogenicity cohort) were seropositive for anti-HPV-16/18 antibodies. Geometric mean titers (GMTs) were 1589.9 ELISA Units [EU]/mL (95% confidence interval [CI]: 1459.8-1731.6) for anti-HPV-16 and 597.2 EU/mL (95% CI: 541.7-658.5) for anti-HPV-18 in subjects seronegative at baseline for the type analyzed.

Indexed as

Immunogenicity, VaccineAdjuvants, ImmunologicAdolescentAntibodies, ViralChildFemaleFollow-Up StudiesHuman papillomavirus 16Human papillomavirus 18HumansPapillomavirus InfectionsPapillomavirus VaccinesTime FactorsUterine Cervical NeoplasmsVaccinationAdjuvants, ImmunologicAntibodies, Viralhuman papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccinescross-reactivityHPV-16/18 AS04-adjuvanted vaccineHPV-31HPV-45immunogenicity persistencenon-vaccine typespredictive modelingsafety

Identifiers

PMID31268383
PMCPMC6746471
OpenAlexW2955745508

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.