Gardasil
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Gardasil | — | 2006-09-20 | europa.eu ↗ |
Trials 50
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-03-17 | Merck Sharp & Dohme LLC | Results Merck to Present New Data Reinforcing Long-Term Efficacy of GARDASIL®9 and GARDASIL® at the EUROGIN International Multidisciplinary HPV Congress 2026 merck.com ↗
Data show long-term effectiveness of GARDASIL ® 9 and GARDASIL ® 14 years and 18 years, respectively, following vaccination with 3 doses |
| 2025-01-08 | Merck Sharp & Dohme LLC | Regulatory Merck’s GARDASIL® Receives Expanded Approval for Males in China merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) of China approved GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases. |
| 2022-11-07 | Merck Sharp & Dohme LLC | Results Reductions in Certain Types of HPV-Related Cervical and Non-Cervical Diseases in Women and Men Observed with Real-World Use of Merck’s GARDASIL® in Systematic Literature Review of 138 Studies merck.com ↗
This systematic review observed that use of GARDASIL led to reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infection in women and men. |
| 2020-10-21 | Merck Sharp & Dohme LLC | Results Merck to Present New Data from its Extensive Infectious Diseases and Vaccines Pipeline and Portfolio During IDWeek 2020 merck.com ↗
Observational Study of Routine Use of 9-Valent Human Papillomavirus Vaccine: Safe in More Than 140,000 Individuals. |
| 2016-06-16 | Merck Sharp & Dohme LLC | Results Systematic Review of 58 Publications of Real-World Use of GARDASIL® Presented at EUROGIN Congress merck.com ↗
Following introduction of vaccination programs with GARDASIL, the earliest impact of the vaccine was seen in the reduction of genital warts. |
| 2011-10-26 | Merck Sharp & Dohme LLC | Results New England Journal of Medicine Publishes Additional Efficacy and Safety Data for GARDASIL® in Males merck.com ↗
These study data add to the large body of clinical trial data that support use of GARDASIL in both females and males to help prevent certain HPV-related cancers and disease. |
| 2011-10-25 | Merck Sharp & Dohme LLC | Regulatory CDC Advisory Committee on Immunization Practices Votes for Expanded Use of GARDASIL® in Boys and Young Men merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to recommend that boys 11 to 12 years old be vaccinated routinely with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] to help prevent anal cancer caused by human papillomavirus (HPV) types 16 and 18, anal dysplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and genital warts caused by HPV types 6 and 11. |
All press releases naming this drug 31 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 83 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gardasil | “Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal...” NCT00325130 ↗79“Quadrivalent HPV vaccine (Gardasil) was given to the participants and serum anti-HPV antibody levels were measured at baseline (before first dose), 7 and 24months after the...” PMID 27406936 ↗ Jul 2016 “Gardasil® (Merck Canada Inc), the Quadravalent Human papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, was selected for this study for its efficacy and safety data in...” NCT02624349 ↗ “This phase IIIb trial compares a single dose of the Cervarix vaccine in girls to 3 doses of the Gardasil vaccine in young women for the prevention of human papillomavirus (HPV)...” NCT03728881 ↗ “Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 mL of GARDASIL as intramuscular injections at the Day 1, Month 2, and Month 6 visits.” NCT00733122 ↗ “The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women.” NCT01034358 ↗ “0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.” NCT00941889 ↗ “Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.” NCT00667563 ↗ “The purpose of the study is to understand if children with liver and kidney transplants develop the antibodies from the Gardasil vaccine.” NCT01101750 ↗ “A Randomized, Parallel Design Study to Compare the Safety and Effectiveness of Gardasil When Delivered Per Standard Practice” NCT02363660 ↗ “In a multi-centre cluster randomized trial of two vs three doses of quadrivalent HPV vaccination (Gardasil™) in India” PMID 29551226 ↗ Mar 2018 |
| Known as | 4-Valent HPV Vaccine | “Gardasil (4-Valent HPV Vaccine)” NCT00543543 ↗ |
| Known as | 4vHPV | “Gardasil® (4vHPV) is a recombinant protein particulate (VLP) vaccine.” NCT04590521 ↗ |
| Known as | GARDASIL (HPV) | “GARDASIL® (HPV)” NCT02199691 ↗ |
| Known as | Gardasil Quadrivalent HPV Types 6, 11, 16, 18 | “Participants received three doses of quadrivalent HPV vaccine (Gardasil Quadrivalent HPV Types 6, 11, 16, 18) and were followed up between 2007 and 2016 (60months post-vaccination).” PMID 31402238 ↗ Aug 2019 |
| Known as | HPV Vaccine | “HPV Vaccine (Gardasil)” NCT01096134 ↗ |
| Known as | qHPV | “The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV...” NCT00090220 ↗ |
| Known as | Quadravalent Human papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | “Gardasil® (Merck Canada Inc), the Quadravalent Human papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, was selected for this study for its efficacy and safety data in...” NCT02624349 ↗ |
| Known as | Quadrivalent HPV vaccine | “Quadrivalent HPV vaccine (Gardasil) was given to the participants and serum anti-HPV antibody levels were measured at baseline (before first dose), 7 and 24months after the...” PMID 27406936 ↗ Jul 2016 |
| Known as | Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ) | “Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)” NCT01512784 ↗ |
| Known as | Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine | “Quadrivalent Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine is GARDASIL®.” NCT01424644 ↗ |
| Known as | Quadrivalent Human Papillomavirus Recombinant vaccine | “Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.” NCT00667563 ↗ |
| Known as | Silgard | “BACKGROUND: GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) vaccine with activity against HPV 6/11/16/18.” PMID 19952980 ↗ Apr 20101“Quadrivalent human papilloma virus (HPV) [types 6, 11, 16, 18] recombinant vaccine (Gardasil®; Silgard®)” PMID 21142263 ↗ Dec 2010 |
| Known as | V501 | “The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV...” NCT00090220 ↗3“Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal...” NCT00325130 ↗ “V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine” NCT00517309 ↗ “Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)” NCT00337428 ↗ |
| Modality | Vaccine | “quadrivalent HPV vaccine” PMID 34780705 ↗ Nov 2021 |
| Route | Intramuscular | “0.5 mL intramuscular injection in the deltoid muscle” NCT00090285 ↗ |