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

NCT00411749 | Completed Phase 2 Results

• 2 other identifiers: V501-0282006_052
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HPV Infections

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series

  24 month after completed vaccination series (Month 30)

Study Arms (2)

V501

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen

Biological: Comparator: Placebo (unspecified)

Interventions

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) BIOLOGICAL

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

Also known as: V501, Gardasil

V501

Comparator: Placebo (unspecified) BIOLOGICAL

Placebo 0.5 ml injection in 3 dosing regimen

Placebo

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Virginal Female Subject Aged 9 To 17 Years

You may not qualify if:

• Male Subject

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 32827835 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Vaccines, Synthetic; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors; Vaccines, Combined; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 15, 2006
• Study Start: December 11, 2006
• Primary Completion: September 18, 2009
• Study Completion: September 18, 2009
• Last Updated: April 21, 2017
• Results First Posted: August 18, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share