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Vaccines

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6

V503

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.

Comparator: Menactra™ (Concomitant)

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.

Comparator: Adacel™ (Concomitant)

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Comparator: Menactra™ (Non-Concomitant)

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Comparator: Adacel™ (Non-concomitant)

Medical Monitor

This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.

A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.

For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving \>50% killing in 60 minutes.

For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of \>=0.1 IU/mL.

For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination.

For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.

Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: \>=30, HPV Type 11: \>=16; HPV Type 16: \>=20, HPV Type 18: \>=24, HPV Type 31: \>=10, HPV Type 33: \>=8, HPV Type 45: \>=8, HPV Type 52: \>=8, and HPV Type 58: \>=8.

Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves \>50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination.

Merck Sharp & Dohme LLC

Adverse events were collected for all participants who received at least one dose of V503, Menactra™, and Adacel™

Concomitant Vaccination

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Non-concomitant Vaccination

Total

Age, Continuous

Sex: Female, Male

Senior Vice President, Global Clinical Development

Anti-HPV 6: n=501, 514

Anti-HPV 11: n=502, 514

Anti-HPV 16: n=513, 530

Anti-HPV 18: n=516, 535

Anti-HPV 31: n=514, 536

Anti-HPV 33: n=520, 537

Anti-HPV 45: n=523, 539

Anti-HPV 52: n=521, 538

Anti-HPV 58: n=519, 537

The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint

Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503

Serogroup A: n=590, 564

Serogroup C:n=590, 566

Serogroup Y: n=590, 566

Serogroup W-135: n=589, 566

The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint

Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups

Anti-diphtheria titer >=0.1 IU/mL: n=595, 566

Anti-tetanus titer >=0.1 IU/mL: n=594, 562

Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody

Anti-PT: n=595, 566

Anti-FHA: n=595, 566

Anti-PRN: n=595, 566

Anti-FIM 2/3: n=595, 566

Geometric Mean Titers of Pertussis Antibody Responses

The population analyzed included all vaccinated participants with follow-up for injection-site AEs

Percentage of Participants With a V503 Injection-site Adverse Experience

Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience

The population analyzed included all vaccinated participants with follow-up

Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)

Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503

Serogroup A: n=595, 567

Serogroup C: n=595, 567

Serogroup Y: n=595, 567

Serogroup W-135: n=595, 567

Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™

Overall Study

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Neoplasms

Rare Diseases

Meningitis

Diphtheria

Whooping Cough

Cough

Tetanus

Tetany

Neoplasms, Glandular and Epithelial

Neuroinflammatory Diseases

Clostridium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Corynebacterium Infections

Bordetella Infections

Gram-Negative Bacterial Infections

Respiratory Tract Infections

Respiratory Tract Diseases

Neoplasms by Histologic Type

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

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

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™

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

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

9 Years of Age and Under

10 to 17 Years of Age

Over 17 Years of Age

Age, Customized

Asian

Black

Hispanic American

Indian

Multi-Racial

Native American

White

Race/Ethnicity

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)	NCT00988884	Human Papilloma...	V503 Comparator: Men... Comparator: Ada... Comparator: Men... Comparator: Ada...	11 Years - 15 Years	Merck Sharp & Dohme LLC
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)	NCT00325130	Neoplasms, Glan... Diphtheria Tetanus Whooping Cough Meningitis	Comparator: Qua... Comparator: Men... Comparator: Ada... Comparator: Men... Comparator: Ada...	11 Years - 17 Years	Merck Sharp & Dohme LLC

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