Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)

A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women- The F.U.T.U.R.E. study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-106-06

Enrollment

380

Registered

2007-01-05

Start date

2007-01-18

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group GARDASIL™ Type of group

The subjects of the study come from studies 011 and 012. All of them were treated with GARDASIL ™ (quadrivalent vaccine against HPV serotypes 6, 12, 16 18 in a particle similar to the L1 virus), at months 0, 2 and 6. Group name:Group Placebo Type of group

The subjects of the study come from studies 011 and 012. All of them were treated with GARDASIL ™ Placebo, in months 0, 2 and 6.

Eligibility

Inclusion criteria

Inclusion criteria: Consult the individual protocol of the substudies (V501-011, V501-012) to see the inclusion criteria in the randomization of the study.

Exclusion criteria

Exclusion criteria: Consult the individual protocol of the substudies (V501-011, V501-012) to see the exclusion criteria in the randomization of the study.

Design outcomes

Primary

Measure	Time frame
Outcome name:The number of patients that meet any of the diagnoses that make up the primary composite endpoint will be identified. The diagnosis of condyloma acuminata (genital warts), VIN 1, VIN 2, VIN 3, VaIN 1, VaIN 2, VaIN 3, vulvar cancer, or vaginal cancer, will be made by consensus of the Pathology Panel of a single individual biopsy or tissue excised. Detection of HPV 6, 11, 16 or 18 by means of the thin section PCR test in an adjacent section of the same block of tissue. Measure:Number of patients that meet the criteria of the endpoint composed of external genital warts, Vulvar Intraepithelial Neoplasia (VIN), or Vaginal Intraepithelial Neoplasia (VaIN), vulvar cancer or vaginal cancer related to HPV Types 6/11/16/18 . Timepoints:Month 48. ; Outcome name:The number of patients that meet any of the diagnoses that make up the primary composite endpoint will be identified. The diagnosis of CIN 1, CIN 2, CIN 3, AIS or cervical cancer, will be made by consensus of the Pathology Panel in an individual sample of biopsy, ECC, LEEP or Conization (cold / laser). Detection of HPV 6, 11, 16 or 18 by means of the thin section PCR test in an adjacent section of the same block of tissue. Measure:Number of patients that meet the criteria of the Endpoint composed of Intraepithelial Cervical Neoplasia (CIN), In Situ Adenocarcinoma (AIS) or Cervical Cancer related to HPV 6, 11. 16 or 18. Timepoints:Month 48.	—

Measure

Time frame

Outcome name:The number of patients that meet any of the diagnoses that make up the primary composite endpoint will be identified. The diagnosis of condyloma acuminata (genital warts), VIN 1, VIN 2, VIN 3, VaIN 1, VaIN 2, VaIN 3, vulvar cancer, or vaginal cancer, will be made by consensus of the Pathology Panel of a single individual biopsy or tissue excised. Detection of HPV 6, 11, 16 or 18 by means of the thin section PCR test in an adjacent section of the same block of tissue. Measure:Number of patients that meet the criteria of the endpoint composed of external genital warts, Vulvar Intraepithelial Neoplasia (VIN), or Vaginal Intraepithelial Neoplasia (VaIN), vulvar cancer or vaginal cancer related to HPV Types 6/11/16/18 . Timepoints:Month 48. ; Outcome name:The number of patients that meet any of the diagnoses that make up the primary composite endpoint will be identified. The diagnosis of CIN 1, CIN 2, CIN 3, AIS or cervical cancer, will be made by consensus of the Pathology Panel in an individual sample of biopsy, ECC, LEEP or Conization (cold / laser). Detection of HPV 6, 11, 16 or 18 by means of the thin section PCR test in an adjacent section of the same block of tissue. Measure:Number of patients that meet the criteria of the Endpoint composed of Intraepithelial Cervical Neoplasia (CIN), In Situ Adenocarcinoma (AIS) or Cervical Cancer related to HPV 6, 11. 16 or 18. Timepoints:Month 48.

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Secondary

Measure	Time frame
Outcome name:Criterion 1: The diagnoses of CIN 1, CIN 2, CIN 3, AIS or cervical cancer, will be made by consensus of the Pathology Panel in an individual sample of biopsy, ECC, LEEP or Conization (cold / laser). Criterion 2: The diagnoses of condyloma acuminata (genital warts), VIN 1, VIN 2, VIN 3, VaIN 1, VaIN 2, VaIN 3, vulvar cancer, or vaginal cancer, will be made by consensus of the Pathology Panel in a single biopsy individual or extirpated tissue. Measure:1) Number of patients that meet the criteria of the Endpoint composed of Intraepithelial Cervical Neoplasia (CIN), In Situ Adenocarcinoma (AIS) or Cervical Cancer related to HPV 16 or 18. 2) Number of patients that meet the criteria of the Endpoint composed of external genital warts, Intraepithelial Vulvar Neoplasia (VIN), or Vaginal Intraepithelial Neoplasia (VaIN), vulvar cancer or vaginal cancer. Timepoints:Month 48. ; Outcome name:Clinical evaluation where any unfavorable and unplanned changes in body structure, function or biochemistry temporarily associated with the use of the study product will be evaluated. The maximum intensity, seriousness, duration, the action taken and the causality will be evaluated. Measure:Security: Adverse events. Timepoints:When the event is presented.	—

Measure

Time frame

Outcome name:Criterion 1: The diagnoses of CIN 1, CIN 2, CIN 3, AIS or cervical cancer, will be made by consensus of the Pathology Panel in an individual sample of biopsy, ECC, LEEP or Conization (cold / laser). Criterion 2: The diagnoses of condyloma acuminata (genital warts), VIN 1, VIN 2, VIN 3, VaIN 1, VaIN 2, VaIN 3, vulvar cancer, or vaginal cancer, will be made by consensus of the Pathology Panel in a single biopsy individual or extirpated tissue. Measure:1) Number of patients that meet the criteria of the Endpoint composed of Intraepithelial Cervical Neoplasia (CIN), In Situ Adenocarcinoma (AIS) or Cervical Cancer related to HPV 16 or 18. 2) Number of patients that meet the criteria of the Endpoint composed of external genital warts, Intraepithelial Vulvar Neoplasia (VIN), or Vaginal Intraepithelial Neoplasia (VaIN), vulvar cancer or vaginal cancer. Timepoints:Month 48. ; Outcome name:Clinical evaluation where any unfavorable and unplanned changes in body structure, function or biochemistry temporarily associated with the use of the study product will be evaluated. The maximum intensity, seriousness, duration, the action taken and the causality will be evaluated. Measure:Security: Adverse events. Timepoints:When the event is presented.

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Countries

Brazil, Colombia, Czech Republic, Germany, Peru, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results