Evidence map›Paper›PMID 27841725›Full record

Trial reportHuman vaccines & immunotherapeutics2016

Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years: Interim analysis of a large community-randomized controlled trial.

Matti Lehtinen, Tiina Eriksson, Dan Apter, Mari Hokkanen, Kari Natunen, Jorma Paavonen, Eero Pukkala, Maria-Genalin Angelo, Julia Zima, Marie-Pierre David and 4 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00534638 (Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299), which is not on this map. Cited by 14 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 6 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT00534638 phase4completednot on this map

Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2014Enrolled34,412ConditionsInfections, PapillomavirusArmsCervarix, Engerix-B
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 6 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Risk of Guillain-Barré syndrome after vaccination against human papillomavirus: a systematic review and meta-analysis, 1 January 2000 to 4 April 2020.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2022
    Pooled it
  3. Pooled it
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  6. Pooled it
  7. Trial
  8. Trial
  9. Review
  10. Article
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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

14 authors at 5 institutions in 2 countries.

Matti Lehtinena University of Tampere , Tampere , Finland.
Tiina Erikssona University of Tampere , Tampere , Finland.
Dan Apterb Family Federation of Finland , Helsinki , Finland.
Mari Hokkanena University of Tampere , Tampere , Finland.
Kari Natunena University of Tampere , Tampere , Finland.
Jorma Paavonenc University of Helsinki , Helsinki , Finland.
Eero Pukkalaa University of Tampere , Tampere , Finland.
Maria-Genalin Angelod GSK Vaccines , Wavre , Belgium.
Julia Zimad GSK Vaccines , Wavre , Belgium.
Marie-Pierre Davidd GSK Vaccines , Wavre , Belgium.
Sanjoy Dattad GSK Vaccines , Wavre , Belgium.
Dan Bid GSK Vaccines , Wavre , Belgium.
Frank Struyfd GSK Vaccines , Wavre , Belgium.
Gary Dubine GSK Vaccines , King of Prussia , PA , USA.
GlaxoSmithKline (Belgium) · BETampere University · FITampere University · FIUniversity of Helsinki · FIVäestöliitto · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This community-randomized controlled trial was initiated to assess the overall and herd effects of 2 different human papillomavirus (HPV) immunization strategies in over 80,000 girls and boys aged 12-15 y in 33 communities in Finland (ClinicalTrials.gov NCT00534638). Overall, 14,838 adolescents received HPV-16/18 vaccine (2,440 boys and 12,398 girls) and 17,338 received hepatitis-B virus (HBV) vaccine (9,221 boys and 8,117 girls). In an interim analysis, vaccine safety was assessed by active monitoring and surveillance via health registry linkage. Active monitoring showed that the HPV-16/18 vaccine has acceptable safety and reactogenicity in boys. In all study participants, the observed incidences (per 100,000 person-years) of serious adverse events (SAEs) possibly related to vaccination were 54.3 (95% Confidence Interval [CI]: 34.0-82.1) in the HPV-16/18 group and 64.0 (95% CI: 43.2-91.3) in the HBV group. During the follow-up period for this interim analysis, the most common new-onset autoimmune diseases (NOADs; with incidence rate ≥15 per 100,000) in any group based on hospital discharge registry (HILMO) download were ulcerative colitis, juvenile arthritis, celiac disease, insulin-dependent diabetes mellitus (IDDM) and Crohn's disease. No increased NOAD incidences were observed in HPV-16/18 vaccine recipients compared to HBV vaccine recipients. In both the SAE possibly related- and HILMO-analyses, a lower incidence of IDDM was observed in HPV-16/18 vaccinees compared to HBV vaccinees (relative risks, 0.26 [95% CI: 0.03-1.24] and 0.16 [95% CI: 0.03-0.55], respectively).

Indexed as

AdolescentAluminum HydroxideAutoimmune DiseasesChildDrug-Related Side Effects and Adverse ReactionsFemaleFinlandHepatitis B VaccinesHumansLipid AMalePapillomavirus InfectionsPapillomavirus VaccinesAluminum HydroxideASO4 mixtureHepatitis B VaccinesLipid APapillomavirus Vaccinesadolescentsautoimmune diseaseHPV-16/18 AS04-adjuvanted vaccineHuman papillomavirus (HPV)insulin-dependent diabetes mellitussafety

Identifiers

PMID27841725
PMCPMC5215585
OpenAlexW2555228742

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.