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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


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
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