# HPV quadrivalent vaccine (types 6, 11, 16 and 18)

Source: https://onco.cc/drugs/hpv-quadrivalent-vaccine/  
OnCo record `hpv-quadrivalent-vaccine` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Gardasil was the first HPV vaccine, licensed in 2006 to prevent cervical and other genital cancers and genital warts. It has been replaced in most countries by the nine-type version, Gardasil 9.

## Summary

The quadrivalent HPV vaccine was approved by the FDA in June 2006 for females aged 9 to 26 to prevent cervical, vulvar and vaginal cancers and precancers and genital warts caused by HPV 6, 11, 16 and 18, on the FUTURE I and II trials, with males (2009) and anal cancer prevention (2010) added; the EU authorised Gardasil in September 2006. It was the first vaccine indicated to prevent a cancer, and population data from Australia, Scandinavia and the UK have since shown large falls in cervical precancer and invasive cancer in vaccinated cohorts. Gardasil 9, covering five further oncogenic types, replaced it in the US in 2017 and in most programmes since. Syncope after injection and injection-site reactions are the main adverse effects; extensive surveillance has found no link to autoimmune disease.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: Silgard
- Tags: nci-list; prevention
- Brand: Gardasil
- Modality: Recombinant virus-like particle vaccine
- Mechanism: L1 virus-like particles of HPV types 6, 11, 16 and 18 on an aluminium adjuvant induce neutralising antibodies that prevent the infections behind most cervical, anal, vulvar and vaginal cancers and genital warts.
- Approvals: US 2006: Prevention of cervical, vulvar and vaginal cancers and precancers and genital warts caused by HPV 6, 11, 16 and 18 in females 9 to 26 (males 2009; anal cancer 2010); superseded by Gardasil 9; EU 2006: Prevention of premalignant genital lesions, cervical cancer and genital warts from age 9 (Gardasil); anal lesions and cancer added later

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Gardasil
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Gardasil
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/recombinant-hpv-quadrivalent-vaccine
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil

## Connected records

- drugs: [HPV bivalent vaccine (types 16 and 18)](https://onco.cc/drugs/hpv-bivalent-vaccine/), [Nonavalent HPV vaccine](https://onco.cc/drugs/gardasil-9/)
- cancers: [Anal cancer (squamous cell carcinoma)](https://onco.cc/cancers/anal/), [Cervical cancer](https://onco.cc/cancers/cervical/), [Vulvar cancer](https://onco.cc/cancers/vulvar/)
- technologies: [Cancer interception vaccines](https://onco.cc/technologies/interception-vaccination/), [HPV & HBV vaccination](https://onco.cc/technologies/hpv-vaccine/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/), [Shanghai Bovax Biotechnology](https://onco.cc/companies/shanghai-bovax-biotechnology/)
- trials: [A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males](https://onco.cc/trials/nct06465914/), [Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females](https://onco.cc/trials/nct04422366/)

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