Evidence map›Paper›PMID 24391768›Full record

Trial reportPloS one2013

Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women.

Joaquin Luna, Manuel Plata, Mauricio Gonzalez, Alfonso Correa, Ivete Maldonado, Claudia Nossa, David Radley, Scott Vuocolo, Richard M Haupt, Alfred Saah

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00090220 (Safety, Immunogenicity, and Efficacy of Gardasil), which is not on this map. Cited by 48 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 9 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.

NCT00090220 phase3completednot on this map

Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2004 to 2015Enrolled3,819ConditionsHealthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18ArmsQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: Placebo
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 9 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Guideline
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review
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

10 authors at 6 institutions in 2 countries.

Joaquin LunaInstituto Nacional de Cancerologia, Bogotá, Colombia.
Manuel PlataFundacion Cardioinfantil, Bogotá, Colombia.
Mauricio GonzalezInstituto Nacional de Cancerologia, Bogotá, Colombia.
Alfonso CorreaClinica del Country, Bogotá, Colombia.
Ivete MaldonadoFundacion Santa Fe de Bogotá, Bogotá, Colombia.
Claudia NossaCafam, Bogotá, Colombia.
David RadleyMerck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
Scott VuocoloMerck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
Richard M HauptMerck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
Alfred SaahMerck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USInstituto Nacional de Cancerología · COClínica Santa María · COFundación Santa Fe de Bogotá · COFundación Universitaria Cafam · COInstitute of Cardiology · CO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women.

methodsFollow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up.

resultsThere were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.

conclusionsVaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women.

trial registrationClinicaltrials.govNCT00090220.

Indexed as

AdultColombiaCondylomata AcuminataDouble-Blind MethodFemaleFollow-Up StudiesHuman papillomavirus 11Human papillomavirus 16Human papillomavirus 18Human papillomavirus 6Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansMiddle AgedPapillomavirus InfectionsPapillomavirus VaccinesPregnancyHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Papillomavirus Vaccines

Identifiers

PMID24391768
PMCPMC3877052
OpenAlexW2034362706

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.