Status:

NOT_YET_RECRUITING

Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening: A Demonstration Project in Rwanda

Lead Sponsor:

Rwanda Biomedical Centre

Collaborating Sponsors:

Merck Sharp & Dohme LLC

Karolinska Institutet

Conditions:

Cervical Cancer

Eligibility:

FEMALE

23-29 years

Phase:

PHASE4

Brief Summary

Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women, with an estimated 604,000 new cases and 342,000 deaths worldwide in 2020. Rwanda i...

Eligibility Criteria

Inclusion

  • Eligible women will include women within the age range of 23-29, who have not opted out of the screening program and who consent to participate in the study

Exclusion

  • Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine. (For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80, or Sodium borate)
  • Known history of immune-related disorders
  • Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection, or low-grade fever.
  • Administration of immunoglobulin or blood-derived products within 6 months prior to the scheduled HPV vaccine first dose
  • Current pregnancy (reported)
  • Women with a total hysterectomy

Key Trial Info

Start Date :

September 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 30 2026

Estimated Enrollment :

100000 Patients enrolled

Trial Details

Trial ID

NCT06536855

Start Date

September 1 2024

End Date

March 30 2026

Last Update

August 5 2024

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