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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00378560
Other study ID # V501-027
Secondary ID 2006_032
Status Completed
Phase Phase 2
First received September 18, 2006
Last updated March 23, 2015
Start date June 2006
Est. completion date September 2009

Study information

Verified date March 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women


Recruitment information / eligibility

Status Completed
Enrollment 1021
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria:

- Female Subject Aged 18 To 26 Years

- With 1-4 Lifetime Sexual Partners

Exclusion Criteria:

- Male Subject

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Comparator: Placebo
Placebo 0.5 ml injection in 3 dosing regimen

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up. Over 30 months No
Secondary Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6) Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.
The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
At one month after completed vaccination series (Month 7) No
Secondary Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11) Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
At one month after completed vaccination series (Month 7) No
Secondary Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16) Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
At one month after completed vaccination series (Month 7) No
Secondary Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18) Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".
At one month after completed vaccination series (Month 7) No
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