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 | Completed Phase 3 Results

• 2 other identifiers: V501-0252005_092
• Study Type: interventional
• Target: 1,042
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neoplasms, Glandular and Epithelial; Diphtheria; Tetanus; Whooping Cough; Meningitis

Outcome Measures

Primary Outcomes (18)

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

• 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™

  7 Months

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

  7 Months

• 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™

  7 Months

• 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™

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

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

  7 Months

Secondary Outcomes (1)

• Acceptable Safety Profile

  15 days post injection

Study Arms (2)

Group 1

EXPERIMENTAL

Concomitant Administration

Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine; Biological: Comparator: Menactra™ (Concomitant); Biological: Comparator: Adacel™ (Concomitant)

Group 2

EXPERIMENTAL

Non-concomitant administration

Biological: Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine; Biological: Comparator: Menactra™ (Non-concomitant); Biological: Comparator: Adacel™

Interventions

Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine BIOLOGICAL

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.

Also known as: Gardasil

Group 1; Group 2

Comparator: Menactra™ (Concomitant) BIOLOGICAL

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

Group 1

Comparator: Adacel™ (Concomitant) BIOLOGICAL

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

Group 1

Comparator: Menactra™ (Non-concomitant) BIOLOGICAL

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

Group 2

Comparator: Adacel™ BIOLOGICAL

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

Group 2

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Must be healthy boys or girls, 11-17 years of age
• Must be a virgin with no intention of becoming sexually active during the study period
• Must have been properly vaccinated against diphtheria, tetanus and pertussis

You may not qualify if:

• Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years
• Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Reisinger KS, Block SL, Collins-Ogle M, Marchant C, Catlett M, Radley D, Sings HL, Haupt RM, Garner EI; Protocol 025 Investigators. Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. Pediatrics. 2010 Jun;125(6):1142-51. doi: 10.1542/peds.2009-2336. Epub 2010 May 3.

  PMID: 20439595 RESULT

MeSH Terms

Conditions

Neoplasms, Glandular and Epithelial; Diphtheria; Tetanus; Whooping Cough; Meningitis

Interventions

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

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

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

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 12, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 12, 2015
• Results First Posted: July 13, 2009

Record last verified: 2015-02