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

Phase 2

Completed

• Conditions: HPV Infections
• Interventions: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)

• Registration Number: NCT00411749
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-12-11
• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Primary Completion: 2009-09-18
• Study Completion: 2009-09-18
• Results First Submitted: 2010-07-19
• Results First Submitted QC: 2010-07-19
• Results First Posted: 2010-08-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

Inclusion Criteria

• Virginal Female Subject Aged 9 To 17 Years

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Exclusion Criteria

• Male Subject

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V501	Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (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.

Primary Outcome Measures

Name	Time	Method
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series	At one month after completed vaccination series (Month 7)	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".
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series	At one month after completed vaccination series (Month 7)	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".
Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series	At one month after completed vaccination series (Month 7)	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".
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series	At one month after completed vaccination series (Month 7)	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".

Secondary Outcome Measures

Name	Time	Method
HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series	24 month after completed vaccination series (Month 30)	Month 30 HPV cLIA Geometric Mean Titers by vaccine group.