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DRUG:

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)

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Other names: V503, 9vHPV, V-503, V 503
Associations
Company:
Chongqing Zhifei, Merck (MSD)
Drug class:
Immunostimulant
Related drugs:
Associations
2d
Trial termination
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CD4 (CD4 Molecule)
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4d
Safety and Immunogenicity of V540B in Healthy Adults (V540B-002) (clinicaltrials.gov)
P1, N=72, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
Enrollment open
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8d
New P1 trial
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
9d
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age (clinicaltrials.gov)
P1/2, N=1080, Completed, GlaxoSmithKline | Active, not recruiting --> Completed | Phase classification: P2 --> P1/2
Trial completion • Phase classification
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
17d
Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women (clinicaltrials.gov)
P=N/A, N=392, Active, not recruiting, Xiamen University | Not yet recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
Enrollment closed • Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) • nonavalent HPV vaccine
21d
HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini (clinicaltrials.gov)
P4, N=1403, Completed, Columbia University | Active, not recruiting --> Completed
Trial completion
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IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • IL2 (Interleukin 2)
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
23d
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen (clinicaltrials.gov)
P4, N=360, Recruiting, Boston Medical Center | Trial completion date: Sep 2025 --> Dec 2025
Trial completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
25d
New P2 trial
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old (clinicaltrials.gov)
P1, N=150, Active, not recruiting, Boston Medical Center | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2028 --> Jul 2028
Enrollment closed • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Molecular detection of high-risk papillomaviruses and vaccination status in normal cytology in Congo. (PubMed, Vopr Virusol)
Our research confirms a widespread HR-HPV infection in our population and extends the importance of studies on the molecular prevalence of HPV, particularly in women with normal cytology and apparent good health, in view of the cruel lack of public awareness of HPV infections.
Journal • Cytology
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Xpert HPV Assay
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
New P2 trial
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
New P1 trial
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Immunogenicity of HPV Vaccine in Transplant Recipients. (clinicaltrials.gov)
P4, N=30, Recruiting, Medical College of Wisconsin | N=100 --> 30
Enrollment change
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Evaluation of the attributable fraction and burden of HPV-related oropharyngeal cancers in Greece-the ORPHEAS study. (PubMed, ESMO Open)
In Greece, we observed a high HPV-AF (52.1%) in OPC, approximating the AFs reported for some Northern European countries. HPV+ versus HPV- patients were younger, more frequently with tonsillar tumors, and less frequently at TNM stage IV. Since most patients were infected by ≥1 HPV type targeted by the 9-valent vaccine, the HPV+ OPC burden could be mitigated through a routine HPV gender-neutral vaccination program.
Journal
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative The NOVEL Trial (clinicaltrials.gov)
P3, N=1000, Active, not recruiting, Imperial College London | Not yet recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Aug 2025 | Trial primary completion date: Jul 2023 --> Aug 2025
Enrollment closed • Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
2ms
Characterization of High-Risk-Other Human Papillomavirus Genotypes in Papanicolaou Tests, High-Grade Squamous Intraepithelial Lesions, and Cervical Cancer. (PubMed)
For the HGSIL and cancer samples, 88% of the samples had full HPV genotype coverage with the 9-valent HPV vaccine. This study highlights a presence of HPV that will not be protected by vaccination in a high-risk population.
Journal
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cobas® HPV test
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
3ms
Enrollment open
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
New P4 trial
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064) (clinicaltrials.gov)
P3, N=1059, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jan 2025 --> Aug 2025 | Trial primary completion date: Jan 2025 --> Dec 2023
Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
4ms
9-VPH-MVIH: Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women (clinicaltrials.gov)
P4, N=158, Active, not recruiting, University Hospital Virgen de las Nieves | Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Jul 2022 --> Sep 2024
Enrollment closed • Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
6ms
Human papillomavirus-driven head and neck cancers in Japan during 2008-2009 and 2018-2019: The BROADEN study. (PubMed, Cancer Sci)
In total, 95.2% of HPV-driven HNC were attributed to HPV genotypes included in the 9-valent HPV vaccine being HPV16 the most prominent genotype. These results suggest that an epidemiologic shift is happening in Japan, with a decrease in smoking and alcohol use and an increase in HPV-driven HNC. The increasing trend of HPV-driven HNC in Japan highlights the need for preventive strategies to mitigate the rise of HPV-driven HNC.
Journal
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
6ms
New P4 trial
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
NCI-2018-02606: Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
P4, N=48, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV (clinicaltrials.gov)
P3, N=700, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting
Enrollment closed
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
Trial completion
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers (clinicaltrials.gov)
P1, N=33, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2026 --> Jun 2027
Trial completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147). (PubMed, Clin Cancer Res)
A higher regression rate than expected was observed in the surveillance arm of this prospective trial. Future clinical trials with imiquimod targeting CIN3 patients are warranted.
P2 data • Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Zyclara (imiquimod) • Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department (clinicaltrials.gov)
P=N/A, N=610, Not yet recruiting, University of Alabama at Birmingham | Initiation date: Mar 2024 --> Sep 2024
Trial initiation date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen (clinicaltrials.gov)
P4, N=360, Recruiting, Boston Medical Center | Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Mar 2024 --> Sep 2024
Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts (clinicaltrials.gov)
P2/3, N=120, Recruiting, Western Institute for Veterans Research | Not yet recruiting --> Recruiting
Enrollment open
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Immunogenicity of 9-valent HPV Vaccine (clinicaltrials.gov)
P4, N=120, Recruiting, Talia Sainz Costa | Not yet recruiting --> Recruiting
Enrollment open
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CD4 (CD4 Molecule)
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose (clinicaltrials.gov)
P4, N=757, Active, not recruiting, The University of Texas Medical Branch, Galveston | Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Mar 2025
Enrollment closed • Trial completion date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
8ms
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients (clinicaltrials.gov)
P2, N=52, Active, not recruiting, National Cancer Institute (NCI) | N=180 --> 52 | Trial completion date: Dec 2023 --> Mar 2025
Enrollment change • Trial completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
9ms
Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants (clinicaltrials.gov)
P2, N=201, Active, not recruiting, National Cancer Institute (NCI) | Phase classification: P2a --> P2 | Trial completion date: Feb 2024 --> Feb 2025
Phase classification • Trial completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
9ms
HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini (clinicaltrials.gov)
P4, N=1403, Active, not recruiting, Columbia University | Trial completion date: Oct 2023 --> Sep 2024
Trial completion date • Head-to-Head
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IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • IL2 (Interleukin 2)
|
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
9ms
Immunogenicity of HPV Vaccine in Transplant Recipients. (clinicaltrials.gov)
P4, N=100, Recruiting, Medical College of Wisconsin | Phase classification: P=N/A --> P4
Phase classification
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial (clinicaltrials.gov)
P4, N=97, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed
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CD4 (CD4 Molecule)
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
New trial
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
COVENANT: HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV (clinicaltrials.gov)
P3, N=536, Active, not recruiting, AIDS Malignancy Consortium | Trial primary completion date: Dec 2025 --> Dec 2024
Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine (clinicaltrials.gov)
P3, N=1260, Active, not recruiting, Beijing Health Guard Biotechnology, Inc | Recruiting --> Active, not recruiting
Enrollment closed
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers (clinicaltrials.gov)
P1, N=33, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2025 --> Apr 2026
Trial initiation date • Trial primary completion date
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
10ms
A Phase III Trial to Evaluate the Immunogenicity and Safety of HPV Vaccine (clinicaltrials.gov)
P3, N=1260, Recruiting, Beijing Health Guard Biotechnology, Inc
New P3 trial
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)