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Comparing Health Services Interventions for the Prevention of HPV-related Cancer (CoheaHr-WP4)

C

CHU de Reims

Status and phase

Completed
Phase 4

Conditions

Cervical Cancer

Treatments

Other: questionnaire
Biological: Gardasil vaccine
Biological: Cervarix®

Study type

Interventional

Funder types

Other

Identifiers

NCT02837926
PO15019

Details and patient eligibility

About

The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

Full description

3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.

Safety data and HPV vaccine compliance will be assessed.

A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.

Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.

Enrollment

63 patients

Sex

Female

Ages

25 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • women within the age range of 25-45
  • attending cervical cancer screening

Exclusion criteria

  • previous history of HPV vaccine administration

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

63 participants in 1 patient group

women attending for cervical cancer screening
Experimental group
Treatment:
Biological: Gardasil vaccine
Other: questionnaire
Biological: Cervarix®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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