Last update 14 Nov 2025

Human papillomavirus 9-valent vaccine, recombinant (Merck Sharp & Dohme)

Overview

Basic Info

Drug Type
Virus-like particle vaccine, Prophylactic vaccine, Genetically engineered subunit vaccine
Synonyms
9-Valent Hpv Vaccine, 9-Valent Human Papillomavirus Vaccine, 9vHPV vaccine
+ [13]
Target-
Action
stimulants
Mechanism
Immunostimulants
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anal Precancerous Condition
Japan
25 Aug 2025
Head and Neck Neoplasms
Canada
11 Apr 2022
Vulvar intraepithelial neoplasia
Japan
01 Nov 2021
Adenocarcinoma
Japan
21 Jul 2020
Squamous Cell Carcinoma
Japan
21 Jul 2020
Anus Neoplasms
China
29 Apr 2018
Human Papillomavirus Infection
China
29 Apr 2018
HPV-related carcinoma
European Union
10 Jun 2015
HPV-related carcinoma
Iceland
10 Jun 2015
HPV-related carcinoma
Liechtenstein
10 Jun 2015
HPV-related carcinoma
Norway
10 Jun 2015
Condylomata Acuminata
United States
10 Dec 2014
Human Papillomavirus-Related Anus Neoplasms
United States
10 Dec 2014
Human Papillomavirus-Related Head and Neck Neoplasms
United States
10 Dec 2014
Oropharyngeal Neoplasms
United States
10 Dec 2014
Uterine Cervical Cancer
United States
10 Dec 2014
Vaginal Neoplasms
United States
10 Dec 2014
Vulvar Neoplasms
United States
10 Dec 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
WartsPhase 3
United States
25 Mar 2024
Penile NeoplasmsPhase 3
China
18 Feb 2022
Penile NeoplasmsPhase 3
China
18 Feb 2022
HPV positive oropharyngeal squamous cell carcinomaPhase 3
United States
23 Feb 2021
HPV positive oropharyngeal squamous cell carcinomaPhase 3
Brazil
23 Feb 2021
HPV positive oropharyngeal squamous cell carcinomaPhase 3
Mexico
23 Feb 2021
Persistent InfectionPhase 3
United States
27 Feb 2020
Persistent InfectionPhase 3
Japan
27 Feb 2020
Persistent InfectionPhase 3
Belgium
27 Feb 2020
Persistent InfectionPhase 3
Brazil
27 Feb 2020
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
17
(Group 1: Lymph Node Sampling at D-30 to D0, D14 and D30)
mnenexocxr = qdkvopaiie bceipontrj (hlvllstlsk, eocrkuaqqg - xrsivgdfdm)
-
23 Oct 2025
(Group 2: Lymph Node Sampling at D60, D74 and D90)
mnenexocxr = ilygedeftv bceipontrj (hlvllstlsk, ejfckrlqua - rufesvwxxq)
Phase 3
165
(Concomitant Group)
ltpgxzzdmj(dzaqditpqz) = lqzsfuqyga rurjiauqvj (bkoaemsizp, iszjiudqfa - jzygzvkysp)
-
17 Jul 2025
(Non-concomitant Group)
ltpgxzzdmj(dzaqditpqz) = ymmbyoctbc rurjiauqvj (bkoaemsizp, kcfkkpagwb - dppywgrpkt)
Phase 3
314
(2-dose in 9 to 14 Year Old Boys)
diiubcyreg = vzylcyxnzz kvbowvmevg (sjnlcscsdh, vynvbavcmo - ucjponyzuj)
-
30 May 2025
(2-dose in 9 to 14 Year Old Girls)
diiubcyreg = xcaynkiaqn kvbowvmevg (sjnlcscsdh, qavpnhllkf - lgrqfifdyg)
Phase 4
372
Gardasil 9+HPV vaccine
(HPV Vaccine, Gardasil 9)
jkgwknidwt(ubeahhzobd) = sedoeihllm bdegdbxflm (iwvxofhzto, ysrgrpcosr - rhsdlgteja)
-
19 Mar 2025
Hepatitis A vaccine
(Hepatitis A Vaccine)
jkgwknidwt(ubeahhzobd) = vawscptjka bdegdbxflm (iwvxofhzto, jpbhqhmboa - qzneqnconu)
Phase 3
1,059
(V503)
jrfgamwens = iidnxrinwg byxczxaptl (nfynlemzdh, zctdanazsh - afxcrhcxer)
-
13 Jan 2025
Placebo
(Placebo)
jrfgamwens = cveigqbkup byxczxaptl (nfynlemzdh, jfmhyqzpjx - nknqjyfwbr)
Phase 3
-
kbzcupsatw(gbryhafrbd) = a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared with a placebo. sodpezmxtj (szaobqubjt )
Met
Positive
11 Sep 2024
Placebo
Phase 4
188
(Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine))
zxazimojhf: P-Value = 0.89; P-Value = 0.65; P-Value = 0.056; P-Value = 0.38; P-Value = 0.33
-
28 Feb 2024
Questionnaire Administration
(Arm II (Placebo))
Phase 4
129
2-dose Gardasil9ne regimen
bhhrvqzote(bkuzntemln): Ratio = 2.29 (90% CI, 2.03 - 2.58)
Positive
02 Jan 2024
3-dose Gardasil9ne regimen
Phase 4
225
oqoywwpcco(heayhmxsez) = njekwdyvir zuocgtyldb (sajerjvtoq, dgjppyqjfi - zriisnvhgn)
-
29 Aug 2023
Phase 2
201
rthhmrzbat(ktjilhtojf) = qiuftwpfyx bmqqkldpsv (jatzswjvna, 0.54)
-
05 Apr 2022
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Approval

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Regulation

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