Clinical trial NCT02653118: Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)
Official title: A Registry-Based Extension of Protocol V503-001 in Countries With Centralized Cervical Cancer Screening Infrastructures to Evaluate the Long-Term Effectiveness, Immunogenicity, and Safety of Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine as Administered to 16- to 26- Year-Old Women
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Genital Warts
Human Papillomavirus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2016-01-12
Enrollment: 4453
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the V503-021 long-term follow-up study received either the selected dose formulation of V503 or GARDASIL in the V503-001 (NCT00543543) base study

Brief summary: Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from the Nordic countries, and the highly efficient screening and surveillance system there, study V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and Sweden. The hypothesis is that V503 vaccine will remain effective for at least 30 years after the start of vaccination.


Eligibility criteria: Inclusion Criteria:

* 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 V503 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:

- There are no exclusion criteria

Primary outcomes:
measure: Combined Incidence of HPV Type 16, 18, 31, 33, 45, 52, or 58-related Cervical Intraepithelial Neoplasia (CIN) Grades 2 or 3, Adenocarcinoma In Situ (AIS), and Cervical Cancer in Cohort 1
timeFrame: Up to 30 years after vaccination in V503-001 base study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Luxembourg A, Kjaer SK, Nygard M, Ellison MC, Group T, Marshall JB, Radley D, Saah A. Design of a long-term follow-up effectiveness, immunogenicity and safety study of women who received the 9-valent human papillomavirus vaccine. Contemp Clin Trials. 2017 Jan;52:54-61. doi: 10.1016/j.cct.2016.10.006. Epub 2016 Oct 21.
citation: Kjaer SK, Nygard M, Sundstrom K, Munk C, Berger S, Dzabic M, Fridrich KE, Waldstrom M, Sorbye SW, Bautista O, Group T, Luxembourg A. Long-term effectiveness of the nine-valent human papillomavirus vaccine in Scandinavian women: interim analysis after 8 years of follow-up. Hum Vaccin Immunother. 2021 Apr 3;17(4):943-949. doi: 10.1080/21645515.2020.1839292. Epub 2020 Dec 16.