Clinical trial • Phase III • Infectious Disease
Human papillomavirus (HPV) L1 virus-like particles for types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (adsorbed) for Human papillomavirus (HPV) infection | Cervical intraepithelial neoplasia (CIN) | Cervical cancer | Vulvar cancer | Vaginal cancer | Genital warts (condyloma acuminata)
Phase III trial of Human papillomavirus (HPV) L1 virus-like particles for types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (adsorbed) for Human papillomavirus…
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Human papillomavirus (HPV) infection | Cervical intraepithelial neoplasia (CIN) | Cervical cancer | Vulvar cancer | Vaginal cancer | Genital warts (condyloma acuminata)
- Trial Stage
- Phase III
- Drug Modality
- Vaccine
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 17-04-2024
- First CTIS Authorization Date
- 24-05-2024
Trial design
open-label, gardasil (recipients of gardasil in the original v503-001 study serve as comparator group)-controlled Phase III trial across 7 sites in Sweden, Denmark, Norway.
- Open Label
- Yes
- Comparator
- GARDASIL (recipients of GARDASIL in the original V503-001 study serve as comparator group)
- Real World Control
- Yes
- Target Sample Size
- 2220
- Trial Duration For Participant
- 10074
Eligibility
Recruits 2220 paediatric patients.
- Vulnerable Population
- No vulnerable populations selected. Participants are females originally enrolled in V503-001 (16- to 26-year-old women). Informed consent is required from participants. Subject information and informed consent forms are available for Sweden (SWE_SV), Denmark (DNK_DA) and Norway (NOR_NN); eConsent forms are available for Denmark.
Inclusion criteria
- {"criterion_text":"- Randomized into the V503-001 (NCT00543543) study from a Denmark, Norway, or Sweden site and participated in the study by receiving either the selected dose formulation of the 9vHPV vaccine or GARDASIL\n- Agrees to allow passive follow-up, analysis of biopsy specimens, future contact from the National Registry Study Centers, and serum collection"}
Exclusion criteria
- {"criterion_text":"- There are no exclusion criteria"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Combined Incidence of Human Papillomavirus (HPV) Type 16, 18, 31, 33, 45, 52, or 58-related CIN Grades 2 or 3, Adenocarcinoma in Situ (AIS), and Cervical Cancer in Cohort 1","definition_or_measurement_approach":"Monitoring the combined incidence of CIN2 or CIN3, Adenocarcinoma in Situ (AIS), and cervical cancer related to HPV types 16, 18, 31, 33, 45, 52, and 58 in Cohort 1 (long-term effectiveness assessment via registry-based follow-up)."}
Secondary endpoints
- {"endpoint_text":"- Combined Incidence of CIN 2, CIN 3, AIS, or cervical cancer related to HPV 35, 39, 51, 56, or 59","definition_or_measurement_approach":"Estimate of combined incidence of CIN2/3, AIS, or cervical cancer related to specified non-vaccine HPV types using registry data."}
- {"endpoint_text":"- Combined Incidence of CIN (any grade), AIS, cervical cancer, vulvar cancer, or vaginal cancer related to HPV 6, 11, 16, 18, 31, 33, 45, 52, or 58","definition_or_measurement_approach":"Estimate of combined incidence of listed neoplasias and cancers related to specified HPV types using registry data."}
- {"endpoint_text":"- Geometric Mean Titers (GMTs) of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58","definition_or_measurement_approach":"Measurement of antibody geometric mean titers for specified HPV types (immunogenicity assessment, presumably via serum testing)."}
- {"endpoint_text":"- Seropositivity rates of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58","definition_or_measurement_approach":"Measurement of seropositivity rates for specified HPV types (immunogenicity assessment, presumably via serum testing)."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 2220
- Recruitment Window Months
- 330
- Consent Approach
- Informed consent obtained from participants (adult female participants). Subject information and informed consent forms available in Swedish (SWE_SV), Danish (DNK_DA) and Norwegian (NOR_NN). eConsent forms are available for Denmark.
Methods
- Passive registry-based follow-up via National Registry Study Centers (participants agree to allow passive follow-up and future contact).
- Letters of invitation and reminder letters (Denmark-specific recruitment documents: multiple 'Letter of Invitation' and reminder documents).
- Recruitment and data linkage via cancer registries (e.g., Cancer Registry of Norway) and national screening infrastructures.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 2220
Sweden
- Earliest CTIS Part Ii Submission Date
- 07-05-2024
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 561
- Number Of Sites
- 1
- Number Of Participants
- 58
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Insitutionen för laboratoriemedicin, Forskningsgatan F56
- Contact Person Name
- Karin Sundström
- Contact Person Email
- karin.sundstrom@ki.se
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-11-2024
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 360
- Number Of Sites
- 5
- Number Of Participants
- 1844
Sites
- Site Name
- Odense University Hospital
- Department Name
- Department of Gynecology and Obstetrics
- Contact Person Name
- Lone Kjeld Petersen
- Contact Person Email
- Lone.kjeld.petersen@rsyd.dk
- Site Name
- Sanos A/S (Vejle)
- Department Name
- Sanos Clinic Vejle
- Contact Person Name
- Sidsel Boll
- Contact Person Email
- sib@sanosclinic.com
- Site Name
- Sanos A/S (Herlev)
- Department Name
- Sanos Clinic Herlev
- Contact Person Name
- Sine Suhr Larsen
- Contact Person Email
- ssl@sanosclinic.com
- Site Name
- Sanos A/S (Gandrup)
- Department Name
- Sanos Clinic Gandrup
- Contact Person Name
- Helene Rovsing
- Contact Person Email
- hel@sanosclinic.com
- Site Name
- Danish Cancer Society Research Center
- Department Name
- Unit of Virus, Lifestyle, and Genes
- Contact Person Name
- Susanne K. Kjaer
- Contact Person Email
- susanne@cancer.dk
Norway
- Earliest CTIS Part Ii Submission Date
- 07-05-2024
- Latest Decision Or Authorization Date
- 17-12-2025
- Processing Time Days
- 589
- Number Of Sites
- 1
- Number Of Participants
- 318
Sites
- Site Name
- Cancer Registry Of Norway
- Department Name
- Cancer Registry of Norway
- Contact Person Name
- Thea Falkenthal
- Contact Person Email
- tehd@kreftregisteret.no
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Third parties
- {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"Sample testing- Immunogenicity (optional Danish substudy only)","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Gardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)
- Active Substance
- Human papillomavirus (HPV) L1 virus-like particles for types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (adsorbed)
- Modality
- Vaccine
- Routes Of Administration
- Intramuscular
- Route
- Intramuscular
- Authorisation Status
- Authorised (marketing authorisation EU/1/15/1007/004)
Related trials
Other published trials that may interest you.
- Conditioned medium from a co-culture of M2-macrophages and fat-derived mesenchymal cells for Acute respiratory distress syndrome (ARDS) | SARS-CoV-2 infection | Influenza A infection | Influenza B infection | Respiratory syncytial virus (RSV) infection
- ACICLOVIR for Recurrent herpes labialis | Herpes simplex labialis
- AMIKACIN SULFATE for Sepsis | Neutropenia
- LENACAPAVIR, ISLATRAVIR for HIV-1 infection
- piperacillin sodium, tazobactam sodium for Extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae severe infection