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Papillomavirus Infections

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Sexually Transmitted Diseases, Viral

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Vaccines

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.

Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

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

Placebo 0.5 ml injection in 3 dosing regimen

Comparator: Placebo (unspecified)

Medical Monitor

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

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

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

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

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".

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".

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".

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".

Month 30 HPV cLIA Geometric Mean Titers by vaccine group.

Merck Sharp & Dohme LLC

All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.

V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)

V501

Placebo vaccination 0.5 ml injection in 3 dosing regimen.

Placebo

Total

Age, Continuous

Sex: Female, Male

Body Weight

Senior Vice President, Global Clinical Development

The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.

Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series

Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series

Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series

Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series

HPV 6 serum antibody titer measured in V501 vaccination group

V501-HPV 6

HPV 11 serum antibody titer measured in V501 vaccination group

V501-HPV 11

HPV 16 serum antibody titer measured in V501 vaccination group

V501-HPV 16

HPV 18 serum antibody titer measured in V501 vaccination group

V501-HPV 18

The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)	NCT00411749	HPV Infections	Quadrivalent Hu... Comparator: Pla...	9 Years - 17 Years	Merck Sharp & Dohme LLC
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)	NCT00411749	HPV Infections	Quadrivalent Hu... Comparator: Pla...	9 Years - 17 Years	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (v501)