ReviewPharmacoepidemiology and drug safety2014
Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience.
Review in Pharmacoepidemiology and drug safety, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- Pooled it
- Guideline
- A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years.Human vaccines & immunotherapeutics · 2019Trial
- Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females.Human vaccines & immunotherapeutics · 2017Trial
- 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.Human vaccines & immunotherapeutics · 2016Trial
- Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial.Human vaccines & immunotherapeutics · 2015Trial
- Trial
- Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination.Human vaccines & immunotherapeutics · 2014Trial
- Post-Marketing Safety Surveillance of Autoimmune Diseases Following Bivalent Human Papillomavirus Vaccination in China.Vaccines · 2026Article
- Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence.Frontiers in drug safety and regulation · 2025Article
- Article
- Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017-2021).Human vaccines & immunotherapeutics · 2023Article
- Recent Advances in the Development of Toll-like Receptor Agonist-Based Vaccine Adjuvants for Infectious Diseases.Pharmaceutics · 2022Review
- Prophylactic and Therapeutic HPV Vaccines: Current Scenario and Perspectives.Frontiers in cellular and infection microbiology · 2022Review
- Review
- Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study.BMJ (Clinical research ed.) · 2021Article
- Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017.British journal of clinical pharmacology · 2019Article
- The factors associated with maternal consent to human papillomavirus vaccination among adolescents in Israel.Human vaccines & immunotherapeutics · 2019Article
- Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009-2017.British journal of clinical pharmacology · 2018Article
- Safety of Human Papillomavirus Vaccines: An Updated Review.Drug safety · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium).
methodsWe describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008-2010).
resultsSpontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain-Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information.
conclusionCollaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit-risk profile in adolescent girls and women.
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What OpenQuestion holds
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.