Gardasil 9
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Gardasil 9 | — | 2015-06-10 | europa.eu ↗ |
Trials 86 · started per year
Also used as a comparator or background therapy in 15 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06688058 Comparator | Dec 2024 → Nov 2026 expected | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06623409 Comparator | Nov 2024 → Nov 2026 expected | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05496231 Comparator | Aug 2022 → Feb 2024 | cervical intraepithelial neoplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07224477 Comparator | Jul 2026 → Apr 2028 expected | — | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05060484 Comparator | Oct 2021 → May 2022 | — | Sinocelltech Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04436133 Comparator | Jun 2020 → Mar 2022 | cervical carcinoma, human papilloma virus infection | National Vaccine and Serum Institute, China | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06207175 Comparator | Nov 2023 → Nov 2024 | human papilloma virus infection | Beijing Health Guard Biotechnology, Inc | Unknown | No outcome recorded |
| Phase 3 | NCT05662020 Comparator | Mar → Nov 2022 overdue | human papilloma virus infection | Beijing Health Guard Biotechnology, Inc | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04782895 Comparator | Mar 2021 → May 2022 | anogenital human papillomavirus infection, cervical cancer | Xiamen University | Completed | No outcome recorded |
| Phase 3 | NCT05372016 Comparator | Sep 2020 → Jun 2022 | adenocarcinoma in situ, anogenital human papillomavirus infection, cervical cancer, cervical intraepithelial neoplasia grade 2/3 +2 | Shanghai Bovax Biotechnology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03832049 Comparator | Sep 2019 → Jun 2024 | — | London School of Hygiene and Tropical Medicine | Unknown | No outcome recorded |
| Phase 3 | NCT02834637 Comparator | Feb 2017 → Jan 2020 overdue | human papilloma virus infection | London School of Hygiene and Tropical Medicine | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02567955 Comparator | Sep 2015 → Sep 2016 | — | Laval University | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02968420 Comparator | Sep 2017 → May 2019 | human papilloma virus infection | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT01824537 Comparator | Jan 2014 → Nov 2022 | human papilloma virus infection | McGill University | Completed | No outcome recorded |
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 110 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gardasil 9 | “METHODS: This is a prospective, single-arm, open-label, non-randomized, Phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose...” PMID 30935375 ↗ Apr 201967“subjects who had participated in one of two trials comparing two and three doses (2D, 3D), were given an additional vaccine dose (Gardasil®9, 9vHPV) several years after the...” PMID 39914257 ↗ Feb 2025 “Since 2015, a second-generation vaccine (Gardasil 9, Sanofi Pasteur MSD SNC) has been available that provides protection against 9 HPV types of which 7 types (16, 18, 31, 33,...” NCT04910802 ↗ “All patients will receive the 9-valent vaccine against HPV (Gardasil9) intramuscularly: After a first open phase evaluating tolerability of Gardasil9, women will be randomized...” NCT03391921 ↗ “Gardasil-9 is a novel, 9-valent HPV recombinant vaccine, which expands the coverage of oncogenic HPV types, with the addition of HPV types 31, 33, 45, 52, and 58 to the...” NCT03947775 ↗ “OBJECTIVE: To test whether the licensed prophylactic HPV vaccine (Gardasil-9) can reduce the risk of HSIL recurrence by 50% in previously unvaccinated individuals recently...” PMID 30977845 ↗ Apr 2019 “assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or...” NCT06624839 ↗ “The three-dose vaccination schedule will be followed with injections at month 0, 2, and 6. Gardasil 9 dosing will be per the recommended and approved labeled guidelines.” NCT03350698 ↗ “This study aimed to compare the immunogenicity of the E coli-produced HPV 9-valent vaccine Cecolin 9 (against HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) with Gardasil 9.” PMID 37475116 ↗ Jul 2023 “The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study.” NCT02968420 ↗ “Up to an additional 2000 girls (daughters of participants in the Kenyan women arm) will be immunized against HPV using the 9-valent HPV vaccine (Gardasil-9).” NCT07240220 ↗ “930 HIV-negative Tanzanian schoolgirls aged 9-14 years were randomised to receive one, two or three doses of Cervarix® or Gardasil®9 (155 per arm)” PMID 42378813 ↗ Jun 2026 “Those consenting will receive free vaccination with the nonavalent Gardasil®9 vaccine, following a three-dose schedule (0, 1-2, 6 months).” NCT06995157 ↗ “Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD).” NCT06588257 ↗ “Administration of Gardasil-9 vaccine as booster dose following 3-dose vaccine series in patients with RRP.” NCT07339163 ↗ “HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12)” NCT05329961 ↗ “using a specific HPV vaccine called Gardasil 9™ which protects against 9 types of HPV infection” NCT03979014 ↗ “nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks” NCT05087849 ↗ “the 9-valent vaccine (Gardasil 9, Sanofi Pasteur MSD, Lyon, France)” PMID 36113532 ↗ Oct 2022 “A second dose of Gardasil9 will be administered 3 years later.” NCT07314307 ↗ “GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months” NCT05372016 ↗ “GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months” NCT05580341 ↗ “9-valent HPV (9vHPV) vaccine, Gardasil-9” PMID 39871186 ↗ Jan 2025 “9vhpv\[Gardasil 9\]-9vhpv\[Gardasil 9\]” NCT07281677 ↗ “(Gardasil 9 human papilloma vaccine)” NCT05202860 ↗ “vaccinated with 9vHPV/Gardasil-9™.” NCT05334706 ↗ “Prevention (Gardasil 9 vaccine)” NCT03023631 ↗ “Active Comparator: GARDASIL ®9” NCT05372016 ↗ “Gardasil 9” NCT06658405 ↗ “Gardasil 9” NCT05985681 ↗ “Gardasil9” NCT02834637 ↗ |
| Known as | 9-valent HPV vaccine | “9-valent HPV vaccine（Gardasil 9）” NCT04436133 ↗ |
| Known as | 9-valent human papillomavirus vaccine | “9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses” NCT03832049 ↗ |
| Known as | 9vHPV | “subjects who had participated in one of two trials comparing two and three doses (2D, 3D), were given an additional vaccine dose (Gardasil®9, 9vHPV) several years after the...” PMID 39914257 ↗ Feb 20257“The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context” NCT07407569 ↗ “Nonavalent HPV vaccine (9vHPV/ Gardasil-9™). Sterile suspension, 0.5 ml dose, intramuscular” NCT07303751 ↗ “The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes” NCT05439083 ↗ “V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection” NCT01047345 ↗ “recombinant 9-valent Human Papillomavirus Vaccine (9vHPV)” NCT04313244 ↗ “9-valent human papillomavirus (9vHPV; V503) vaccine” NCT03998254 ↗ “vaccinated with 9vHPV/Gardasil-9™.” NCT05334706 ↗ |
| Known as | 9vHPV vaccine | “a 9-valent human papillomavirus (9vHPV) vaccine (HPV-6/11/16/18/31/33/45/52/58) is recommended” PMID 38320488 ↗ Jan 2024 |
| Known as | Cecolin 9 | “9vhpv\[Cecolin 9\]- 9vhpv\[Cecolin 9\]” NCT07281677 ↗ |
| Known as | GARDASIL 9 -MSD | “Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD).” NCT06588257 ↗ |
| Known as | Gardasil(R) 9 | “Commercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6” NCT05202860 ↗ |
| Known as | Gardisil-9 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07240220 ↗ |
| Known as | HPV9 | “Participants received three intramuscular doses of either quadrivalent HPV vaccine (HPV4; enrolments on or before March 1, 2016) or nonavalent HPV vaccine (HPV9; enrolments...” PMID 34767765 ↗ Nov 2021 |
| Known as | HPV9v | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03626467 ↗ |
| Known as | Human papillomavirus (HPV) vaccine, 9-valent | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06624839 ↗ |
| Known as | Human papillomavirus 9-valent vaccine, recombinant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05266898 ↗ |
| Known as | Nonavalent HPV vaccine | “Participants received three intramuscular doses of either quadrivalent HPV vaccine (HPV4; enrolments on or before March 1, 2016) or nonavalent HPV vaccine (HPV9; enrolments...” PMID 34767765 ↗ Nov 2021 |
| Known as | nonavalent human papillomavirus vaccine | “nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks” NCT05087849 ↗ |
| Known as | recombinant 9-valent Human Papillomavirus Vaccine | “recombinant 9-valent Human Papillomavirus Vaccine (9vHPV)” NCT04313244 ↗ |
| Known as | Recombinant Human Papillomavirus Nonavalent Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05237947 ↗ |
| Known as | V503 | “9-valent human papillomavirus (9vHPV; V503) vaccine” NCT05285826 ↗ |
| Modality | Vaccine | “A 9-valent HPV (9vHPV) vaccine has been developed to protect against HPV type 6/11/16/18/31/33/45/52/58-related infection and disease.” PMID 29211620 ↗ Dec 2017 |
| Route | Intramuscular | “Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6.” PMID 25693011 ↗ Feb 2015 |