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Completed

NCT Number: NCT00325130

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)

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.

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Key information

Conditions

Neoplasms, Glandular and Epithelial Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Clostridium Infections Corynebacterium Infections Diphtheria Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Meningitis Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neuroinflammatory Diseases Respiratory Tract Diseases Respiratory Tract Infections Tetanus Whooping Cough

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Gardasil

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

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

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

Comparator: Adacel™

Biological

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

Primary outcomes

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

  7. 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™

    Time frame: 7 Months

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

    Time frame: 7 Months

  9. 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™

    Time frame: 7 Months

  10. 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™

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

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

    Time frame: 7 Months

Secondary outcomes

  1. Acceptable Safety Profile

    Time frame: 15 days post injection

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 12, 2006
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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