Know Cancer

or
forgot password

A Long-term Follow-up Registry-based Cohort Study of HPV Vaccine Efficacy Against Cervical Pre-cancerous Lesions and Cervical Cancers in a Cohort of Females Previously Enrolled From Finland in Study HPV-008, as Compared to a Non-intervention Population -Based Reference Cohort of Females From Finland


N/A
16 Years
19 Years
Open (Enrolling by invite only)
Female
Uterine Cervical Cancer

Thank you

Trial Information

A Long-term Follow-up Registry-based Cohort Study of HPV Vaccine Efficacy Against Cervical Pre-cancerous Lesions and Cervical Cancers in a Cohort of Females Previously Enrolled From Finland in Study HPV-008, as Compared to a Non-intervention Population -Based Reference Cohort of Females From Finland


Inclusion Criteria:



- Trial Cohort (16-17 years at baseline) - the cohort of Finnish subjects who
participated in the GSK Biologicals' HPV-008 trial (NCT00122681):

- Cohort A: subjects who received HPV-16/18 L1 VLP AS04 vaccine between May 2004 and
May 2005.

- Cohort B: subjects who received the Hepatitis A control vaccine. All subjects were
offered the HPV-16/18 L1 VLP AS04 vaccine at the end of the study (age 21-22).

- Cohort B1: subjects who received the Hepatitis A control vaccine and then received
cross-over HPV vaccination at HPV-008 study end.

- Cohort B2: subjects who received the Hepatitis A control vaccine and who did not
receive cross-over HPV vaccination at HPV-008 study end.

- Referent cohort (18-19 years at baseline):

- Cohort C: A population-based reference cohort of female subjects from Finland who
have not been exposed to any HPV vaccine enrolled in this study in May 2005,
immediately after recruitment of the HPV-008 clinical trial subjects had been stopped
(approximately 9,000 subjects).

Exclusion Criteria:

- Trial Cohort (Cohort A and B): Previous or planned administration of an HPV vaccine
not foreseen by the HPV-008 study protocol or any HPV-008 extension study protocol
(Gardasil or any experimental HPV vaccine).

- Referent cohort (Cohort C): Previous or planned administration of an HPV vaccine
(Cervarix, Gardasil or any experimental HPV vaccine).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Occurrence of intraepithelial neoplasia grade 3 or worse (CIN3+). including CIN3, cervical cancer (squamous cell carcinoma or adenocarcinoma).

Outcome Description:

To estimate the long-term vaccine efficacy by comparing the incidence rate of cervical cancers and pre-cancerous lesions (CIN3+) in Cohort A vs. Cohort C.

Outcome Time Frame:

The time frame is up to 15 years (for the interim analyses: 4, 7 and 10 years). (Start and end of passive follow-up, Cohorts A and B: 01.01.2010 - 31.12. 2024; Cohorts C1 and C2: 01.10.2007/01.10.2008 - 30.09.2021/30.09.2023.)

Safety Issue:

No

Principal Investigator

Matti Lehtinen, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tampere

Authority:

Finland: Finnish Medicines Agency

Study ID:

115006 (HPV-027)

NCT ID:

NCT01393470

Start Date:

May 2011

Completion Date:

December 2024

Related Keywords:

  • Uterine Cervical Cancer
  • HPV
  • Vaccine
  • long-term efficacy
  • registry-based study
  • Evaluation of long-term HPV vaccine efficacy: a population-based, registry-based cohort study in Finland.
  • Uterine Cervical Neoplasms

Name

Location