Last updated: 02/13/2019 09:30:31

Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants

GSK study ID
CDR0000441189
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.
Trial description: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.
PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of histopathologically confirmed Cervical Intraepithelial Neoplasia (CIN)2+ cases associated with HPV16 and/or HPV18 infection detected in the preceding cervical cytology specimen.

Timeframe: From Month 6 up to Month 48

Secondary outcomes:

Number of cervical infection with HPV16 or HPV18.

Timeframe: From Month 6 up to Month 48

Number of histopathologically confirmed CIN2+ cases associated with infection by any oncogenic HPV type

Timeframe: From Month 6 up to Month 48

Number of persistent infection (12-month definition) with human papillomavirus (HPV)-16 or HPV-18 cases

Timeframe: From Month 6 up to Month 48

Geometric mean titers (GMTs) for HPV-16 antibody in the immunogenicity subcohort.

Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

Geometric mean titers (GMTs) for HPV-18 antibody in the immunogenicity subcohort

Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal antibody Inhibition Test)

Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal antibody Inhibition Test)

Timeframe: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48

Number of subjects reporting any and Grade 3 solicited local symptoms.

Timeframe: Within 60 minutes after vaccination

Number of subjects reporting any and Grade 3 solicited general symptoms.

Timeframe: Within 60 minutes after vaccination

Number of subjects reporting any and Grade 3 solicited local symptoms on a 10% random subset of participants.

Timeframe: From Day 3 to Day 6 after vaccination

Number of subjects reporting any and Grade 3 solicited general symptoms on a 10% random subset of participants.

Timeframe: From Day 3 to Day 6 after vaccination

Number of subjects reporting serious adverse events (SAEs).

Timeframe: During the entire study period (From Month 0 up to Month 48).

Number of subjects reporting unsolicited adverse events (AEs).

Timeframe: During the entire study period (From Month 0 up to Month 48).

Number of subjects with all possible pregnancy outcomes

Timeframe: During the entire study period (From Month 0 up to Month 48).

Number of cervical infection with HPV16 or HPV18.

Timeframe: During the first year of follow-up period

Number of cervical infection with HPV16 or HPV18.

Timeframe: During the second year of follow-up period

Number of cervical infection with HPV16 or HPV18.

Timeframe: During the third year of follow-up period

Number of cervical infection with HPV16 or HPV18.

Timeframe: From the fourth year follow-up period

Number of subjects reporting unsolicited adverse events (AEs).

Timeframe: within 30 days (Days 0-29) after vaccination

Interventions:
  • Biological/vaccine: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine
  • Biological/vaccine: hepatitis A inactivated virus vaccine
  • Enrollment:
    7466
    Primary completion date:
    2010-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kreimer AR, Rodriguez AC, Hildesheim A, Herrero R, Porras C, Schiffman M, Gonzalez P, Solomon D, Jimenez S, Schiller JT, Lowy DR, Quint W, Sherman ME, Schussler J, Wacholder S. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst 2011;103:1444-51. PMC3186781
    Kemp TJ, Hildesheim A, Safaeian M, Dauner JG, Pan Y, Porras C, Schiller JT, Lowy DR, Herrero R, Pinto LA. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine 2011;29:2011-4. PMC3046309
    Medical condition
    Cervical Cancer, Precancerous Condition
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    June 2004 to December 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    18 - 25 years
    Accepts healthy volunteers
    Yes
    • DISEASE CHARACTERISTICS:
    • Healthy participants

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Proyecto Epidemiologico Guanacaste
    Liberia, Costa Rica
    Status
    Recruiting

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-31-12
    Actual study completion date
    2010-31-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Link Text: Clinical trial summary from the National Cancer Institute's PDQ® database
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