Evidence map›Paper›PMID 39315334›Full record

Trial reportFrontiers in cellular and infection microbiology2024

Head-to-head comparison of two human papillomavirus vaccines for efficacy against cervical intraepithelial neoplasia grade 3 and adenocarcinoma

Matti Lehtinen, Penelope Gray, Tapio Luostarinen, Tiina Eriksson, Dan Apter, Anne Bly, Katja Harjula, Kaisa Heikkilä, Mari Hokkanen, Marjo Kuortti and 8 more

3 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in cellular and infection microbiology, 2024. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT00092534 phase3completednot on this map

A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2002 to 2025Enrolled12,167ConditionsCervical Cancer, Genital WartsArmsGardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine, Matching Placebo
NCT00122681 phase3completednot on this map

A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2009Enrolled18,729ConditionsInfections, PapillomavirusArmsCervarix™, Havrix™-based investigational formulation
NCT00169494 phase3completednot on this map

Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2005Enrolled770ConditionsInfections, PapillomavirusArmsHPV-16/18 L1/AS04
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. [Vaccine prevention of HPV-associated diseases].Dermatologie (Heidelberg, Germany) · 2026
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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

18 authors.

Matti LehtinenDepartment of CLINTEC, Karolinska Institute, Stockholm, Sweden.
Penelope GrayDepartment of CLINTEC, Karolinska Institute, Stockholm, Sweden.
Tapio LuostarinenInstitute for Epidemiological Cancer Research, Finnish Cancer Registry, Helsinki, Finland.
Tiina ErikssonFaculty of Medicine, Tampere University, Tampere, Finland.
Dan ApterYouth Clinic, VL-Medi, Helsinki, Finland.
Anne BlyFaculty of Medicine, Tampere University, Tampere, Finland.
Katja HarjulaFaculty of Medicine, Tampere University, Tampere, Finland.
Kaisa HeikkiläFaculty of Medicine, Tampere University, Tampere, Finland.
Mari HokkanenFaculty of Medicine, Tampere University, Tampere, Finland.
Marjo KuorttiFaculty of Medicine, Tampere University, Tampere, Finland.
Pekka NieminenDepartment of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.
Mervi NummelaFaculty of Medicine, Tampere University, Tampere, Finland.
Jorma PaavonenDepartment of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland.
Johanna PalmrothDepartment of Obstetrics and Gynecology, University of East-Finland, Kuopio, Finland.
Tiina PetäjäFaculty of Medicine, Tampere University, Tampere, Finland.
Ville N PimenoffDepartment of CLINTEC, Karolinska Institute, Stockholm, Sweden.
Eero PukkalaInstitute for Epidemiological Cancer Research, Finnish Cancer Registry, Helsinki, Finland.
Joakim DillnerDepartment of CLINTEC, Karolinska Institute, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: We report head-to-head comparison of the bivalent and quadrivalent HPV vaccine efficacies against immediate precursors of cervical cancer from 15 years' country-wide cancer registry follow-up of phase III trial cohorts and an age-aligned cohort of unvaccinated women. Methods: These individually and/or clusterrandomized cohorts of HPV6/11/16/18- and HPV16/18-vaccinated and unvaccinated women were enrolled, respectively, in 2002, 2004, and 2003/2005. The trial cohorts comprised initially 16- to 17-year-old HPV6/11/16/18-vaccinated FUTURE II (NCT00092534) participants (866) and HPV16/18-vaccinated PATRICIA (NCT00122681) and 012 trial (NCT00169494) participants (2,465), and 16,526 initially 16- to 19-year-old unvaccinated controls. After active 4-year clinical follow-up, passive, country-wide Finnish Cancer Registry (FCR) follow-up for cervical intraepithelial neoplasia grade 3 (CIN3) and adenocarcinoma in situ (AIS) was based on consented use of unique personal identifiers and started 6 months after the end of the FUTURE II and PATRICIA trials in 2007 and 2009, and ended at the end of 2019. The follow-up with altogether 229,020 follow-up years was age-aligned to ensure that similarly aged cohorts were passively followed up for 15 years post=vaccination for the intention-to-treat analyses of vaccine efficacy. Results: Overall, we identified 5 and 16 CIN3 (no AIS) cases in the HPV6/11/16/18 and HPV16/18 cohorts, respectively, during the FCR-based follow-up. In the unvaccinated cohort, we identified 281 CIN3 cases, 20 AIS cases, and 13 cases with invasive cervical cancer. Vaccine efficacies against CIN3+ were 68.4% and 64.5% for the quadrivalent and the bivalent vaccines, respectively, with overlapping confidence intervals. Discussion: Long-term follow-up of randomized, initially adolescent HPV-vaccinated and unvaccinated cohorts shows, in this head-to-head setting, that the bivalent and quadrivalent HPV vaccines are equally effective against immediate precursors of cervical cancer.

Indexed as

Adenocarcinoma in SituPapillomavirus InfectionsPapillomavirus VaccinesUterine Cervical DysplasiaUterine Cervical NeoplasmsAdolescentAdultFemaleFinlandFollow-Up StudiesHumansTreatment OutcomeVaccinationYoung AdultPapillomavirus Vaccinescervical neoplasiafollow-uphuman papillomavirusrandomized trialvaccine efficacy

Identifiers

PMID39315334
PMCPMC11417099

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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.