V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

HPV Infections Clinical Trial

Official title:

V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411749
• Other study ID #: V501-028
• Secondary ID: 2006_052
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2006
• Last updated: October 30, 2015
• Start date: December 2006
• Est. completion date: September 2009

Study information

• Verified date: October 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

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Virginal Female Subject Aged 9 To 17 Years

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

• HPV Infections

Intervention

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series	Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) 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
Primary	Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series	Month 7 HPV Competitive Luminex immunoassay (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
Primary	Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series	Month 7 HPV Competitive Luminex immunoassay (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
Primary	Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series	Month 7 HPV Competitive Luminex immunoassay (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
Secondary	HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series	Month 30 HPV cLIA Geometric Mean Titers by vaccine group.	24 month after completed vaccination series (Month 30)	No