Overview
Sponsor-declared trial summary
9vHPV vaccine is indicated in females ≥ 9 years of age in the prevention of cervical, vulvar, vaginal, and anal cancer; precancerous or dysplastic lesions; and persistent infections caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58, and genital warts (condyloma acuminata) caused by HPV types 6 and 11.
To assess the long-term effectiveness of the 9vHPV vaccine by monitoring the combined incidence of Cervical Intraepithelial Neoplasia (CIN) 2, CIN 3, Adenocarcinoma In Situ (AIS) and cervical cancer related to HPV 16, 18, 31, 33, 45, 52, and 58 in women from Protocol V503-001 in the Nordic region vaccinated with the 9v…
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 14 Mar 2008 → ongoing
- Decision date (initial)
- 2024-12-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-508683-30-00
- EudraCT number
- 2013-003549-40
- WHO UTN
- U1111-1305-8498
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Others, Safety, Efficacy
To assess the long-term effectiveness of the 9vHPV vaccine by monitoring the combined incidence of Cervical Intraepithelial Neoplasia (CIN) 2, CIN 3, Adenocarcinoma In Situ (AIS) and cervical cancer related to HPV 16, 18, 31, 33, 45, 52, and 58 in women from Protocol V503-001 in the Nordic region vaccinated with the 9vHPV vaccine
Secondary objectives 3
- To estimate the combined incidence of CIN 2, CIN 3, AIS, and cervical cancer related to non-vaccine HPV types 35, 39, 51, 56 and 59 in women from Protocol V503-001 in the Nordic region vaccinated with the 9vHPV vaccine
- To estimate long-term effectiveness of the 9vHPV vaccine against CIN 1, CIN 2, and CIN 3, AIS, cervical cancer, vulvar cancer (in situ or invasive), or vaginal cancer (in situ or invasive) related to HPV 6, 11,16, 18, 31, 33, 45, 52, and/or 58
- To evaluate the long-term HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibody responses generated by the 9vHPV vaccine
Conditions and MedDRA coding
9vHPV vaccine is indicated in females ≥ 9 years of age in the prevention of cervical, vulvar, vaginal, and anal cancer; precancerous or dysplastic lesions; and persistent infections caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58, and genital warts (condyloma acuminata) caused by HPV types 6 and 11.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10071147 | Human papilloma virus immunization | 10042613 |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2007-003528-39 | A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL™, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26-Year-Old Women |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 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
- Agrees to allow passive follow-up, analysis of biopsy specimens, future contact from the National Registry Study Centers, and serum collection
Exclusion criteria 1
- There are no exclusion criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 4
- Combined Incidence of CIN 2, CIN 3, AIS, or cervical cancer related to HPV 35, 39, 51, 56, or 59
- 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
- Geometric Mean Titers (GMTs) of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Seropositivity rates of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7273288 · Product
- Active substance
- Human Papillomavirus Type 31 L1 Protein - Adsorbed - in the Form of Virus-Like Particles Produced in Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) by Rdna
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0 ml millilitre(s)
- Max total dose
- 0 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BM03 — -
- Marketing authorisation
- EU/1/15/1007/004
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Alain Luxembourg
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Alain Luxembourg
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Q Squared Solutions Holdings LLC ORG-100043288
|
Valencia, United States | Other |
Locations
3 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 1,844 | 5 |
| Norway | Ongoing, recruiting | 318 | 1 |
| Sweden | Ended | 58 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2008-03-14 | 2008-03-14 | |||
| Sweden | 2016-02-08 | 2025-07-30 | 2024-05-28 | 2024-05-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-508683-30_for pub | 03 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure LT FU_NOR_EN_SM04_for pub | 1-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_DNK_EN_for pub | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Letter odaf Invitation_Histo reminder_DNK_DA_for pub | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Letter of Invitation_DNK_DA_for pub | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Letter of Invitation_FU_DNK_DA_for pub | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Letter of Invitation_Histo_DNK_DA_for pub | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Letter of Invitation_reminder_DNK_DA_for pub | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Subject Recruitment_DNK_DA_for pub | 02Sep2024 |
| Recruitment arrangements (for publication) | V503-021 CTIS Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_NOR_NN_SM04-RFI005_for pub | 16DEC2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main adult consent_DNK_DA_for pub | 1-0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main adult consent_eConsent_DNK_DA_for pub | 1-0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_eConsent_DNK_DA_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NOR_NN_for pub | 8 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SWE_SV_for pub | 07AUG2013 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR addendum_NOR_NN_SM04-RFI002_for pub | 23MAY2022 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gardasil9_for pub | 25JUL2023 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508683-30_for pub | 1-0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508683-30_SWE_SV_for pub | 1-0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-17 | Norway | Acceptable 2024-05-24
|
2024-05-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-03 | Norway | Acceptable 2024-09-02
|
2024-09-02 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-09-09 | Acceptable 2024-09-02
|
2024-12-01 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-17 | Norway | Acceptable 2025-11-17
|
2025-11-17 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-18 | Norway | Acceptable 2025-11-17
|
2025-12-18 |