Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337428
• Other study ID #: V501-024
• Secondary ID: 2005_093
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2006
• Last updated: March 12, 2015
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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, pertussis and polio

Exclusion Criteria:

• Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years

• Must not have received any prior human papillomavirus (HPV) vaccine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Neoplasms, Glandular and Epithelial
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
• Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
• Comparator: REPEVAX™ (Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
• Comparator: REPEVAX™ (Non-Concomitant)
REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Vesikari T, Van Damme P, Lindblad N, Pfletschinger U, Radley D, Ryan D, Vuocolo S, Haupt RM, Guris D. An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vacc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Seroconverted for HPV Type 6 (HPV 6 = 20 mMU/mL) by Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 = 16 mMU/mL) by Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 = 20 mMU/mL) by Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18= 20 mMU/mL) by Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Number of Subjects Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria = 0.1 IU/mL) One Month Postvaccination With REPEVAX™		One month postvaccination with REPEVAX™	No
Primary	Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus = 0.1 IU/mL) One Month Postvaccination With REPEVAX™		One month postvaccination with REPEVAX™	No
Primary	Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 = 1:8) One Month Postvaccination With REPEVAX™		one month postvaccination with REPEVAX™	No
Primary	Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 = 1:8) One Month Postvaccination With REPEVAX™		One month postvaccination with REPEVAX™	No
Primary	Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 = 1:8) One Month Postvaccination With REPEVAX™		one month postvaccination with REPEVAX™	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 of qHPV		7 Months (Week 4 Postdose 3)	No
Primary	Geometric Mean Titers (GMTs) for Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™		One month postvaccination with REPEVAX™	No
Primary	Geometric Mean Titers (GMTs) for Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™		One month postvaccination with REPEVAX™	No
Primary	Geometric Mean Titers (GMTs) for Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™		One month postvaccination with REPEVAX™	No
Primary	Geometric Mean Titers (GMTs) for Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™		One month postvaccination with REPEVAX™	No