Research
Print page Print page
Switch language
Rigshospitalet - a part of Copenhagen University Hospital
Published

Design of a long-term follow-up effectiveness, immunogenicity and safety study of women who received the 9-valent human papillomavirus vaccine

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Effect of levothyroxine on live birth rate in euthyroid women with recurrent miscarriage and TPO antibodies (T4-LIFE study)

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Bacillus Calmette-Guérin immunisation at birth and morbidity among Danish children: A prospective, randomised, clinical trial

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Trial Sequential Analysis has the potential to improve the reliability of conclusions in meta-analysis

    Research output: Contribution to journalLetterResearchpeer-review

  1. Ovarian removal at or after benign hysterectomy and breast cancer: a nationwide cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Use of nonaspirin nonsteroidal anti-inflammatory drugs and risk of head and neck cancer: A nationwide case-control study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Prevalence, type distribution, and risk factors for oral HPV in Danish renal transplant recipients

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Human papillomavirus vaccination in immigrants and descendants of immigrants in Denmark

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Alain Luxembourg
  • Susanne K Kjaer
  • Mari Nygard
  • Misoo C Ellison
  • Thomas Group
  • J Brooke Marshall
  • David R Radley
  • Alfred Saah
View graph of relations

The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets four HPV types (6/11/16/18) also covered by the quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). Vaccine efficacy to prevent HPV infection and disease was established in a Phase III clinical study in women 16-26years of age. A long-term follow-up (LTFU) study has been initiated as an extension of the Phase III clinical study to assess effectiveness of the 9vHPV vaccine up to at least 14years after the start of vaccination. It includes participants from Denmark, Norway and Sweden and uses national health registries from these countries to assess incidence of cervical pre-cancers and cancers due to the 7 oncogenic types in the vaccine (HPV 16/18/31/33/45/52/58). Incidences will be compared to the estimated incidence rate in an unvaccinated cohort of similar age and risk level. This LTFU study uses a unique design: it is an extension of a Phase III clinical study and also has elements of an epidemiological study (i.e., endpoints based on standard clinical practice; surveillance using searches from health registries); it uses a control chart method to determine whether vaccine effectiveness may be waning. Control chart methods which were developed in industrial and manufacturing settings for process and production monitoring, can be used to monitor disease incidence in real-time and promptly detect a decrease in vaccine effectiveness. Experience from this innovative study design may be applicable to other medicinal products when long-term outcomes need to be assessed, there is no control group, or outcomes are rare.

Original languageEnglish
JournalContemporary Clinical Trials
Volume52
Pages (from-to)54-61
Number of pages8
ISSN1551-7144
DOIs
Publication statusPublished - Jan 2017

    Research areas

  • Journal Article

ID: 50608000