Participant information V501
In the LTFU V501 study, you and the other participants are indirectly followed through any treatments registered about you in the Cancer Registry, along with data from other health registries. We will collect information about you dating back to 2017, which is the time of the previous follow-up's conclusion.
If you have had tissue samples (biopsies) taken from your cervix or if other changes related to HPV have been discovered, we will retrieve these samples from the laboratory.
You do not need to take any action, and you will not be contacted in connection with our data collection or potential biopsies.
The study does not involve new sample taking or examinations of you, and it will also not affect your participation in the Cervical Cancer Screening Program or any further follow-up and treatment in the specialist healthcare services.
Remember that even if you have received the HPV vaccine, you should continue to participate in the Cervical Cancer Screening Program and have cervical samples taken if you experience symptoms.
Blood Samples
Participation involves being asked to provide blood samples twice during the study period. The first round of blood samples is currently ongoing and will be completed in the fall of 2023. The next round of blood sample collection is planned for 2025.
If you have consented to participate in the study, you should have received an offer with information about the location, time, and procedure for blood sample collection.
If you do not wish to give a blood sample, you can still participate in the study, as passive follow-up using health registry data is essential to investigate the vaccine's long-term effects.
More information for you as a study participant:
Your participation in the extended follow-up study will contribute to research and knowledge about the HPV vaccine. As a participant in the clinical trial of the HPV vaccine Gardasil, you were among the first in the world to receive the vaccine. Today, millions of people have received the vaccine. Those who received the vaccine early are the ones who can provide reliable information about the vaccine's characteristics. By choosing to participate in this follow-up study, you will contribute to valuable knowledge about the vaccine's duration (effectiveness). While your participation doesn't offer direct benefits to you, the study's results can provide knowledge to the population and society as a whole, which can help prevent cervical cancer and other HPV-related diseases.
Apart from the time it takes for blood sample collection, there are no significant practical drawbacks for you personally to participate in this study. There's always a certain level of privacy risk associated with the processing of personal data, especially the transfer of data to the USA and potentially to regulatory authorities in countries with different degrees of protection compared to the EEA. To minimize the privacy risks, we have established various technical and legal measures, including pseudonymization, encryption, and contracts.
Participation in the study is voluntary. If you wish to participate, you can sign the consent declaration on the last page and return it to us in the pre-paid envelope provided. Alternatively, you can also sign digitally by scanning the QR code on the same page using your smartphone's camera (requires logging in via IDporten with bankID) and following the instructions provided.
You have the right to withdraw your consent at any time, without providing a reason. This will not have any negative consequences for you or any medical follow-up. In this case, no new information will be collected about you, but the information and biological material that has already been collected and transferred to the USA or used in analyses/published will still be part of the study and will be stored in accordance with applicable regulations and the study protocol.
If you consent to participate, the information collected in the previous studies you have participated in (the main clinical study and the first follow-up study) will be included in this extended follow-up study.
You have the right to access the information that has been registered about you and the right to correct any errors. You also have the right to know what security measures have been implemented in the processing of this information. Furthermore, you have the right to restrict the processing of your information. Certain exceptions to these rights are outlined in accordance with Article 89(1) of the General Data Protection Regulation, in line with the Personal Data Act § 17.
The right to deletion does not apply to information included in the previous studies, as the processing is necessary to fulfill a legal obligation that requires the processing of personal data, as outlined in Article 17(3)(b) of the General Data Protection Regulation.
You can find more information about your rights, privacy, and information security on the Kreftregisteret's website: https://www.kreftregisteret.no/en/General/About-the-Cancer-Registry/Privacy/
The information about you and the samples you have provided will be processed without any connection to your name, social security number, or other direct identifying characteristics. Your social security number will be replaced with a sequential number that links you to your information through a separate code list stored on secure servers at the Cancer Registry. The information we collect about you in this study will be linked to the information from the clinical trial and long-term follow-up you have participated in. Only a few authorized personnel at the Cancer Registry, who are bound by confidentiality, will have access to the code list and can perform the linkage.
All processing of information and samples, including storage, analysis, and transmission, will occur in pseudonymized form. This means that no researchers or project staff will know who you are. It will also not be possible to identify you in the results of the study when they are published.
Pseudonymized health information about you will be transferred to the USA for evaluating the vaccine's effectiveness and may be shared with national and international regulatory authorities for the evaluation of the vaccine's effectiveness. In addition to pseudonymization, the transferred information will be encrypted. The Cancer Registry has entered into an agreement with Merck for joint data responsibility that ensures participants' rights and freedoms in accordance with the General Data Protection Regulation (GDPR) Article 26.
If HPV-related biopsies are taken during the study period, they will be collected from the pathology laboratory after any treatment has taken place. The biopsies will be sent to collaborating pathology laboratories in Norway, Sweden, Denmark, and Iceland for analysis and then returned to the Cancer Registry, where they will be stored in an approved research biobank associated with the project. Project leader Thea Falkenthal is responsible for the research biobank. Any remaining biopsy material will be returned to the original pathology laboratory. HPV testing of biopsies and measurement of antibodies in blood samples will be conducted at an approved laboratory in the USA, and any remaining material will be stored in approved research biobanks associated with Merck. For control purposes, the material in the study's research biobanks will be stored for up to two years after the study's end and will then be destroyed.
The procedures for processing, analyzing, storing, and transmitting information and biological material are the same as in the vaccine studies you have previously participated in. This ensures that all samples and data undergo a thorough and standardized assessment throughout the study course. The information about you and the samples you have provided will only be used for the purposes of the study in accordance with ethical approval from the Regional Committee for Medical and Health Research Ethics (REK) and applicable legislation. Any extensions in usage and storage time can only occur after approval from REK and other relevant authorities.
The project's end date is 2026. According to the Clinical Trials Regulation EU No. 536/2014 Article 58, the study's data must be archived for at least 25 years after the end of the study. The purpose is to ensure that the drug's documentation can be reviewed by authorities if necessary. The information will then be deleted. Storage is subject to strict access control, and only a few individuals associated with Merck have access to the information.
The information transferred to the United States may, upon request from regulatory authorities such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and potentially other drug authorities in countries outside Europe and the USA, be shared with them for the purpose of reviewing the safety, reliability, and effectiveness of the vaccine.
To facilitate the transfer of information and analysis of biological material, a legal basis for transfer is required. According to the General Data Protection Regulation (GDPR), personal data can be transferred to countries within the European Economic Area (EEA) or to countries that have received an adequacy decision from the EU Commission. However, the USA does not have such an adequacy decision. In cases like this, information can still be transferred if necessary safeguards are in place under GDPR Article 46.
For transfers to the laboratory in the USA, we have determined that the EU's standard contractual clauses under GDPR Article 46(2)(c) can be used. However, we have assessed that, at this time, necessary guarantees cannot be provided under this provision for the transfer of personal data from Norway to Merck's clinical study database in the USA, or for the further sharing of personal data by Merck with drug authorities both within and outside the USA. This is due, in part, to legal conflicts between European and American law that authorities are working to resolve, but these solutions will take time. For these transfers, we must therefore, for the time being, use the derogation specified in GDPR Article 49(1)(b).
The Data Protection Authority was notified on 24th June 2022, following the conditions set out in the derogation. As per this provision, in addition to notifying the Data Protection Authority, the Cancer Registry of Norway is also required to inform study participants about the transfers and the compelling legitimate interests that justify the use of the derogation. These interests are further described below.
Approval of Merck's first HPV vaccine (Gardasil-4) by the FDA required the monitoring of the vaccine's long-term effects in the Nordic region. Without such monitoring, the vaccine would not have been offered to young girls (eventually also boys). The HPV vaccine study is grounded in the interest of public health and society's justified expectations for increased knowledge about health and disease. Norway is among the very few countries in the world where this type of study can be conducted due to our robust health registries that can be interconnected. Furthermore, the long-term follow-up study cannot be substituted by other studies, as only the participants of this study can provide similar insights into the vaccine's long-term effectiveness and safety. The transfer of information, therefore, benefits both you as a participant and future recipients of the HPV vaccine. Enhanced knowledge about the vaccine's effect is crucial for assessing its ability to prevent HPV-related cancer. Kreftregisteret thus has reason to believe that you and others consenting to participate in this study are supportive of the transfer and processing of personal data for this purpose.
The processing of personal data in this study is legally grounded in GDPR Article 6(1)(c) and Article 9(2)(i). The processing is necessary to fulfill legal requirements for reliability, safety, and effectiveness imposed on clinical trials. Additionally, the Norwegian Medicines Act, the Regulation on Clinical Trials of Medicines for Human Use, Section 15-6a of the Medicines Regulation, and Annex II, Chapter XIII, No. 18 (Regulation (EU) No. 536/2014) of the EEA Agreement provide supplementary legal basis in national law for processing health data for this purpose. Other processing of personal data in the study is legally grounded in GDPR Article 6(1)(e) and Article 9(2)(j), as well as Sections 8 and 9 of the Norwegian Personal Data Act. This processing is necessary for scientific research purposes.
Given the measures implemented to ensure the security of personal data, we evaluate that the processing aligns with the principles and requirements of GDPR. Any potential expansion in the use of data and retention period can only occur with renewed approval from the Regional Committee for Medical and Health Research Ethics (REK) and other relevant authorities. Such processing must be in accordance with personal data regulations and consistent with the original purpose.
