CompletedPhase 3

Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

12,167 participantsStarted 2002-06-14

Plain-language summary

The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.

Who can participate

Age range16 Years – 23 Years

SexFEMALE

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Inclusion criteria

✓-For Extension Phase:
✓-For LTFU:

Exclusion criteria

✕-For Extension Phase:
✕-For LTFU Study:

What they're measuring

Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study

Timeframe: Up to 4 years

Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study

Timeframe: Up to 14 years since Vaccine Dose 1

Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study

Timeframe: up to 22 years post Vaccination Dose 1

Trial details

NCT IDNCT00092534

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07-31

Results submitted2009-07-20

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