Evidence map›Paper›PMID 34581025›Full record

Trial reportCancer medicine2021

Effectiveness of various human papillomavirus vaccination strategies: A community randomized trial in Finland.

Matti Lehtinen, Dan Apter, Tiina Eriksson, Katja Harjula, Mari Hokkanen, Kari Natunen, Pekka Nieminen, Jorma Paavonen, Johanna Palmroth, Tiina Petäjä and 6 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 35% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. The quality of life of frequently vs. infrequently screened HPV vaccinated women.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
    Trial
  3. Trial
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

16 authors at 7 institutions in 3 countries.

Matti LehtinenDepartment of Vaccines, National Institute for Health & Welfare, Helsinki, Finland.ORCID 0000-0002-9481-0535
Dan ApterVL-Medi Clinical Research Center, Helsinki, Finland.
Tiina ErikssonFaculty of Social Sciences, Tampere University, Tampere, Finland.
Katja HarjulaFaculty of Social Sciences, Tampere University, Tampere, Finland.
Mari HokkanenFaculty of Social Sciences, Tampere University, Tampere, Finland.
Kari NatunenFaculty of Social Sciences, Tampere University, Tampere, Finland.
Pekka NieminenDepartment of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.
Jorma PaavonenDepartment of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.
Johanna PalmrothFaculty of Social Sciences, Tampere University, Tampere, Finland.
Tiina PetäjäFaculty of Social Sciences, Tampere University, Tampere, Finland.
Eero PukkalaFaculty of Social Sciences, Tampere University, Tampere, Finland.ORCID 0000-0001-9536-6440
Simopekka VänskäFinnish Institute for Health and Welfare, Helsinki and Oulu, Finland.ORCID 0000-0002-5677-721X
Brigitte CheuvartGSK, Wavre, Belgium.
Maaria SoilaGSK, Espoo, Finland.
Dan BiGSK, Wavre, Belgium.
Frank StruyfGSK, Wavre, Belgium.
Tampere University · FIGlaxoSmithKline (Belgium) · BEUniversity of Helsinki · FIFinnish Institute for Health and Welfare · FIGlaxosmithkline (Finland) · FIKarolinska Institutet · SEVL-Medi Oy (Finland) · FI

Funding

GlaxoSmithKline Biologicals SA HPV-040
6 · The paper itself

Abstract

introductionWe conducted a community-randomized trial (NCTBLINDED) in Finland to assess gender-neutral and girls-only vaccination strategies with the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18)vaccine.

methodsGirls and boys (12-15 years) were invited. We randomized 33 communities (1:1:1 ratio): Arm A: 90% of randomly selected girls and boys received AS04-HPV-16/18 vaccine and 10% received hepatitis B vaccine (HBV); Arm B: 90% of randomly selected girls received AS04-HPV-16/18 vaccine, 10% of girls received HBV, and all boys received HBV; Arm C: all participants received HBV. Effectiveness measurements against prevalence of HPV-16/18 cervical infection were estimated in girls at 18.5 years. The main measures were: (1) overall effectiveness comparing Arms A or B, regardless of vaccination status, vs Arm C; (2) total effectiveness comparing AS04-HPV-16/18 vaccinated girls in pooled Arms A/B vs Arm C; (3) indirect effectiveness (herd effect) comparing girls receiving HBV or unvaccinated in Arm A vs Arm C. Co-primary objectives were overall effectiveness following gender-neutral or girls-only vaccination.

resultsOf 80,272 adolescents invited, 34,412 were enrolled. Overall effectiveness was 23.8% (95% confidence interval: -19.0, 51.1; P = 0.232) with gender-neutral vaccination. Following girls-only vaccination, overall effectiveness was 49.6% (20.1, 68.2; P = 0.004). Total effectiveness was over 90% regardless of vaccination strategy. No herd effect was found. Immunogenicity of the AS04-HPV-16/18 vaccine was high in both sexes.

conclusionsThis study illustrates the difficulty in conducting community randomized trials. It is not plausible that vaccinating boys would reduce overall effectiveness, and the apparent lack of herd effect was unexpected given findings from other studies. This analysis was likely confounded by several factors but confirms the vaccine's high total effectiveness as in clinical trials.

Indexed as

Human papillomavirus 16Human papillomavirus 18Papillomavirus VaccinesAdolescentChildFemaleFinlandHumansMaleMass VaccinationPapillomavirus InfectionsPrevalenceUterine Cervical NeoplasmsPapillomavirus Vaccinescommunitygender-neutralhuman papillomavirusvaccination strategy

Identifiers

PMID34581025
PMCPMC8559511
OpenAlexW3203460302

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.