The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,055
qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Time frame: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Time frame: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
Time frame: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Time frame: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Time frame: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)