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All Drugs and Chemicals

Vaccines

Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a

0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.

Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1

Comparator: Menactra™ (Concomitant)

a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1

Comparator: Adacel™ (Concomitant)

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1

Comparator: Menactra™ (Non-concomitant)

Comparator: Adacel™

Medical Monitor

Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) \[Types 6, 11, 16, 18\] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V501 Given Concomitantly With Menactra™ and ADACEL™ in Healthy Adolescents 11-17 Years of Age

Merck Sharp & Dohme LLC

Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™

Concomitant Administration

Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™

Non-concomitant Administration

Total

Age, Continuous

9 Years of Age and Under

10 to 17 Years of Age

Over 17 Years of Age

Age, Customized

Sex: Female, Male

Asian

Black

Hispanic American

Indian

Multi-Racial

Native American

White

Race/Ethnicity

Senior Vice President, Global Clinical Development

Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)

Acceptable Safety Profile

Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)

Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)

Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)

Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™

Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™

Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™

Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™

Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™

Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™

Per-protocol population: subjects must

have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have

post-vaccination data.

Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™

Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™

Per-protocol population: subjects must

have no major protocol violations and must have post-vaccination data.

Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™

Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™

Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™

Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™

Overall Study

Spots Global Cancer Trial Database for comparator: adacel™