Drug updated on 4/17/2024
| Dosage Form | Injection (intramuscular; 0.5 mL) |
| Drug Class | Vaccines |
| 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
- 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
| Document Title | Year | Source |
|---|---|---|
| Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, 18 vaccine recombinant]) Prescribing Information. | 2015 | Merck Canada Inc., Kirkland, QC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Human papillomavirus vaccination: good clinical practice recommendations from the Federation of Obstetric and Gynecological Societies of India. | 2020 | The Journal of Obstetrics and Gynaecology Research |
| Human papillomavirus vaccination 2020 guideline update: American Cancer Society guideline adaptation. | 2020 | Cancer Journal for Clinicians |
| Multidisciplinary, evidence-based consensus guidelines for human papillomavirus (HPV) vaccination in high-risk populations, Spain, 2016. | 2019 | Eurosurveillance |