Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Human Papilloma Virus, Cervical Cancer, Vulvar Cancer
About this trial
This is an interventional prevention trial for Human Papilloma Virus
Eligibility Criteria
Inclusion Criteria:
- Participant is in good physical health
- Participant has had a lifetime history of 0 to 4 sexual partners
- Females between 18-to-24 years
Exclusion Criteria:
- Participant has a history of abnormal Pap test
- Participant has a history of positive test for HPV
- Participant has a history of recent or ongoing alcohol or drug abuse
- Participant is immunocompromised or has an autoimmune condition
- Participant has received immunosuppressive therapy within a year of screening
- Participant has previously received an HPV vaccine
- Participant is pregnant
- Participant has a history of external genital/vaginal warts
- Participant is currently enrolled in a clinical trial
- Participant has a history of a severe allergic reaction that required medical attention
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
qHPV (GARDASIL™) - Phase A Control
Octavalent HPV with 15 mcg IMX / AAHS
Octavalent HPV with 30 mcg IMX / AAHS
qHPV (GARDASIL™) - Phase B Control
Octavalent HPV with 60 mcg IMX / AAHS
Octavalent HPV with 120 mcg IMX / AAHS
Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A.
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX.
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX.
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B.
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX.
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX.