Human papillomavirus quadrivalent (types 6, 11, 16, 18 vaccine recombinant)

(Gardasil®)

Gardasil®

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Drug updated on 4/17/2024

Dosage FormInjection (intramuscular; 0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in girls and women 9- through 26 years of age for the prevention of infection caused by the Human Papillomavirus (HPV) types 6, 11, 16, and 18 and the following diseases associated with the HPV types included in the vaccine: Ccervical, vulvar, and vaginal and anal cancer caused by HPV types 16 and 18, and genital warts (condyloma acuminata) caused by HPV types 6 and 11.
  • Indicated for the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18: Cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grade 2 and grade 3, vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, and cervical intraepithelial neoplasia (CIN) grade 1.
  • Indicated in boys and men 9 through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16, and 18 and the following diseases associated with the HPV types included in the vaccine: aAnal cancer caused by HPV types16 and 18, genital warts (condyloma acuminata) caused by HPV types 6 and 11, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18.

Summary
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  • Human papillomavirus quadrivalent (types 6, 11, 16, 18 vaccine recombinant), or Gardasil, is indicated for the prevention of infections caused by HPV types and associated diseases in girls/women and boys/men aged between 9 to 26 years. These include cervical, vulvar, vaginal, and anal cancer; genital warts; as well as precancerous or dysplastic lesions.
  • The information provided here is derived from a total of eighteen systematic reviews/meta-analyses documents that cover various aspects including safety, effectiveness comparison with other HPV vaccines, and subpopulation considerations.
  • In terms of efficacy against HPV strains when compared to bivalent HPV vaccine (2v-HPV), no statistically significant differences are observed. However, nonavalent HPV vaccine (9v-HPV) demonstrated superior effectiveness in preventing additional strains not covered by either the bivalent or quadrivalent versions.
  • Safety analysis indicates a very low risk of Guillain-Barré Syndrome following vaccination with Gardasil. Furthermore, there is an absence of a clear association between this vaccine and autoimmune or other rare diseases, which suggests good safety profiles even after extensive post-license data collection.
  • Subpopulation considerations reveal real-world evidence supporting use among women with prior cervical disease, individuals suffering from recurrent respiratory papillomatosis, while also highlighting gaps in data for transgender/non-binary individuals and female sex workers.
  • People living with HIV demonstrate a robust and safe immune response to this vaccine despite some findings indicating possibly shorter, less robust protection against the type-18 strain.
  • The studies overwhelmingly show high effectiveness in preventing infections and associated diseases among adolescents and youth, thus supporting expansion programs targeting younger populations before the onset of sexual activity.
  • Observational studies suggest potential benefits of extending vaccination programs to include males, providing protection against genital warts and potentially reducing transmission.

Product Monograph / Prescribing Information

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative effects of bivalent, quadrivalent, and nonavalent human papillomavirus vaccines in the prevention of genotype-specific infection: a systematic review and network meta-analysis.2023Infection & Chemotherapy
Approaches to estimating clearance rates for human papillomavirus groupings: a systematic review and real data examples.2023Epidemiology
Risk of Guillain–Barré syndrome after vaccination against human papillomavirus: a systematic review and meta-analysis, 1 January 2000 to 4 April 2020.2022Eurosurveillance
Human papillomavirus vaccine impact and effectiveness in six high-risk populations: a systematic literature review.2022Vaccines
Real-world impact and effectiveness of the quadrivalent HPV vaccine: an updated systematic literature review.2022Expert Review of Vaccines
Immunogenicity, safety, and efficacy of the HPV vaccines among people living with HIV: a systematic review and meta-analysis.2022eClinicalMedicine
Genotype prevalence and age distribution of human papillomavirus from infection to cervical cancer in Japanese women: a systematic review and meta-analysis.2022Vaccine
Human papillomavirus vaccine effectiveness by number of doses: updated systematic review of data from national immunization programs.2022Vaccine
HPV vaccination among seropositive, DNA negative cohorts: a systematic review & meta-analysis.2022Journal of Gynecologic Oncology
Real-world impact and effectiveness assessment of the quadrivalent HPV vaccine: a systematic review of study designs and data sources.2022Expert Review of Vaccines
Systematic literature review of neutralizing antibody immune responses to non-vaccine targeted high-risk HPV types induced by the bivalent and the quadrivalent vaccines.2021Vaccine
Sex difference in the immunogenicity of the quadrivalent human papilloma virus vaccine: systematic review and meta-analysis.2021Vaccine
Systematic literature review of cross-protective effect of HPV vaccines based on data from randomized clinical trials and real-world evidence.2021Vaccine
Systematic literature review of neutralizing antibody immune responses to non-vaccine targeted high-risk HPV types induced by the bivalent and the quadrivalent vaccines.2021Vaccine
The quadrivalent HPV vaccine is protective against genital warts: a meta-analysis.2020BMC Public Health
Systematic review and meta-analysis of postlicensure observational studies on human papillomavirus vaccination and autoimmune and other rare adverse events.2020The Pediatric Infectious Disease Journal
Pregnancy outcomes after human papillomavirus vaccination in periconceptional period or during pregnancy: a systematic review and meta-analysis.2019Human Vaccines & Immunotherapeutics
Comparison of different human papillomavirus (HPV) vaccine types and dose schedules for prevention of HPV-related disease in females and males.2019Journal of Adolescent and Young Adult Oncology

Clinical Practice Guidelines