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

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

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

Study Overview

• Status: Completed
• Conditions: HPV Infections
• Intervention / Treatment: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501); Biological: Comparator: Placebo (unspecified)

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Virginal Female Subject Aged 9 To 17 Years

Exclusion Criteria:

• Male Subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V501; V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6.	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501); V501; Gardasil, 0.5 ml injection in 3 dosing regimen; Other Names: Gardasil; V501
Placebo Comparator: Placebo; Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen	Biological: Comparator: Placebo (unspecified); Placebo 0.5 ml injection in 3 dosing regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2006
• Primary Completion (Actual): September 18, 2009
• Study Completion (Actual): September 18, 2009

Study Registration Dates

• First Submitted: December 14, 2006
• First Submitted That Met QC Criteria: December 14, 2006
• First Posted (Estimate): December 15, 2006

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: V501-028; 2006_052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php