Clinical Trial: A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadoles

Brief Summary: This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]
    Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
  • Percentage of Participants With an Injection-site Adverse Event (AE) [ Time Frame: up to 5 days after any vaccination ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
  • Percentage of Participants With a Non-Injection Site (Systemic) AE [ Time Frame: up to 15 days after any vaccination ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also

    Original Primary Outcome:

    • Number of participants who seroconvert for Human Papillomavirus (HPV) Type 6 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 11 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 16 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 18 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 31 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 33 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 45 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 52 [ Time Frame: Month 7 (1 month postdose 3) ]
    • Number of participants who seroconvert for HPV Type 58 [ Time Frame: Month 7 (1 month postdose 3) ]


    Current Secondary Outcome: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine [ Time Frame: 4 weeks post-vaccination 3 (Month 7) ]

    Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.


    Original Secondary Outcome:

    • Geometric mean titer (GMT) of HPV Type 6 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 11 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 16 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 18 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 31 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 33 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 45 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 52 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]
    • Geometric mean titer (GMT) of HPV Type 58 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ]


    Information By: Merck Sharp & Dohme Corp.

    Dates:
    Date Received: December 3, 2010
    Date Started: January 2011
    Date Completion:
    Last Updated: February 17, 2017
    Last Verified: February 2017