Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00851643 | Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) | PHASE1 | COMPLETED | 158 | — | — | Apr 1, 2006 | Nov 1, 2009 | Feb 3, 2016 | - | — |
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
| Arm | Type | Description |
|---|---|---|
| qHPV (GARDASIL™) - Phase A Control | ACTIVE_COMPARATOR | 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 HPV with 15 mcg IMX / AAHS | EXPERIMENTAL | 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 HPV with 30 mcg IMX / AAHS | EXPERIMENTAL | 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. |
| qHPV (GARDASIL™) - Phase B Control | ACTIVE_COMPARATOR | 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 HPV with 60 mcg IMX / AAHS | EXPERIMENTAL | 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 HPV with 120 mcg IMX / AAHS | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Octavalent HPV with 15 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Octavalent HPV with 30 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Octavalent HPV with 60 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Octavalent HPV with 120 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™) | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
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 ...