TriangleNCT03158220 · STUDY IN CONTEXT
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
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
Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.
An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.
Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed
Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.
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-vaginal-cancer
- nct id
- NCT03158220
- trial label
- Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
- 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
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0000
- source section id
- NCT03158220-om-0000
- source outcome index
- 0
- endpoint
- Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
- endpoint definition
- Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).
- time origin
- 4 weeks post vaccination 3 (Month 7)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.
- 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-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0001
- source section id
- NCT03158220-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants That Experienced at Least 1 Adverse Event (AE)
- endpoint definition
- An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.
- time origin
- Up to 1 month post vaccination 3 (up to 7 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination and had available data for endpoint.
- 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-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0002
- source section id
- NCT03158220-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.
- endpoint definition
- An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.
- time origin
- Up to 1 month post vaccination 3 (up to 7 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination and had available data for endpoint.
- 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-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0003
- source section id
- NCT03158220-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
- endpoint definition
- Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.
- time origin
- Up to 5 days post any vaccination
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination and had available data for endpoint.
- 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-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0004
- source section id
- NCT03158220-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants That Reported at Least 1 Systemic Adverse Event
- endpoint definition
- An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed
- time origin
- Up to 15 days post any vaccination
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination and had available data for endpoint.
- 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-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0005
- source section id
- NCT03158220-om-0005
- source outcome index
- 5
- endpoint
- Percentage of Participants With Elevated Temperature (Fever)
- endpoint definition
- Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.
- time origin
- Up to 5 days post any vaccination
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination and had available data for endpoint.
- 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-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Women 16-26 Years of Age
- regimen
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 485
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Women 27-45 Years of Age
- regimen
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 533
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Women 16-26 Years of Age
- regimen
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 570
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Women 27-45 Years of Age
- regimen
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 640
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Women 16-26 Years of Age
- regimen
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 570
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Women 27-45 Years of Age
- regimen
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 640
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Women 16-26 Years of Age
- regimen
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 570
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Women 27-45 Years of Age
- regimen
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 640
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Women 16-26 Years of Age
- regimen
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 570
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Women 27-45 Years of Age
- regimen
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 640
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Women 16-26 Years of Age
- regimen
- Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 570
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Women 27-45 Years of Age
- regimen
- Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
- analyzed count
- 640
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03158220-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-vaginal-cancer
- nct id
- NCT03158220
- harm key
- EG000
- source section id
- NCT03158220-ae
- event group key
- EG000
- event group label
- Women 16-26 Years of Age
- serious affected
- 6
- serious at risk
- 570
- other affected
- 518
- other at risk
- 570
- frequency threshold
- 5
- collection period
- Up to 1 month post vaccination 3 (up to 7 months)
- event definition
- Population included all participants that received at least 1 vaccination.
- 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-vaginal-cancer
- nct id
- NCT03158220
- harm key
- EG001
- source section id
- NCT03158220-ae
- event group key
- EG001
- event group label
- Women 27-45 Years of Age
- serious affected
- 8
- serious at risk
- 640
- other affected
- 574
- other at risk
- 640
- frequency threshold
- 5
- collection period
- Up to 1 month post vaccination 3 (up to 7 months)
- event definition
- Population included all participants that received at least 1 vaccination.
- 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