TriangleNCT00851643 · STUDY IN CONTEXT
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- trial label
- Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0000
- source section id
- NCT00851643-om-0000
- source outcome index
- 0
- endpoint
- Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
- endpoint definition
- 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.
- time origin
- 4 weeks postdose 3 (Phase A)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0001
- source section id
- NCT00851643-om-0001
- source outcome index
- 1
- endpoint
- Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
- endpoint definition
- 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.
- time origin
- 4 weeks postdose 3 (Phase B)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0002
- source section id
- NCT00851643-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
- endpoint definition
- 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.
- time origin
- 4 weeks postdose 3 (Phase A)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0003
- source section id
- NCT00851643-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
- endpoint definition
- 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.
- time origin
- 4 weeks postdose 3 (Phase B)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0000
- arm key
- OG000
- arm label
- qHPV (GARDASIL™) - Phase A Control
- regimen
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Octavalent HPV With 15 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Octavalent HPV With 30 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0001
- arm key
- OG000
- arm label
- qHPV (GARDASIL™) - Phase B Control
- regimen
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Octavalent HPV With 60 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Octavalent HPV With 120 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0002
- arm key
- OG000
- arm label
- qHPV (GARDASIL™) - Phase A Control
- regimen
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Octavalent HPV With 15 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Octavalent HPV With 30 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0003
- arm key
- OG000
- arm label
- qHPV (GARDASIL™) - Phase B Control
- regimen
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Octavalent HPV With 60 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Octavalent HPV With 120 mcg IMX / AAHS
- regimen
- Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00851643-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- harm key
- EG000
- source section id
- NCT00851643-ae
- event group key
- EG000
- event group label
- qHPV (GARDASIL™) - Phase A and Phase B Controls
- serious affected
- 0
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 5
- collection period
- All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- harm key
- EG001
- source section id
- NCT00851643-ae
- event group key
- EG001
- event group label
- Octavalent HPV With 15 mcg IMX / AAHS
- serious affected
- 0
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 5
- collection period
- All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- harm key
- EG002
- source section id
- NCT00851643-ae
- event group key
- EG002
- event group label
- Octavalent HPV With 30 mcg IMX / AAHS
- serious affected
- 0
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 5
- collection period
- All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- harm key
- EG003
- source section id
- NCT00851643-ae
- event group key
- EG003
- event group label
- Octavalent HPV With 60 mcg IMX / AAHS
- serious affected
- 0
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 5
- collection period
- All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT00851643
- harm key
- EG004
- source section id
- NCT00851643-ae
- event group key
- EG004
- event group label
- Octavalent With 120 mcg IMX / AAHS
- serious affected
- 0
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 5
- collection period
- All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice