Cervical Cancer, HPV, Premalignancy Anogenital Warts
Conditions
Brief summary
This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.
Interventions
BIOLOGICALComparator: Gardasil
0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICALComparator: octavalent HPV Vaccine - dose formulation 1
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICALComparator: octavalent HPV Vaccine - dose formulation 2
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICALComparator: octavalent HPV Vaccine - dose formulation 3
0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 23 Years
Healthy volunteers
Yes
Inclusion criteria
* Lifetime history of 0-4 sexual partners
Exclusion criteria
* History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. | 4 weeks post dose 3 injection |
Outcome results
None listed