TriangleNCT01047345 · STUDY IN CONTEXT
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" is defined as a vaccine-related SAE.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter \>2 inches (\>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.
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
- NCT01047345
- trial label
- A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
- 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0000
- source section id
- NCT01047345-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
- endpoint definition
- An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
- time origin
- up to 5 days after any vaccination - Base Study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 vaccination and had available follow-up data.
- 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
- NCT01047345
- outcome key
- om-0001
- source section id
- NCT01047345-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study
- endpoint definition
- Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.
- time origin
- up to 5 days after any vaccination - Base Study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 vaccination and had available temperature data.
- 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
- NCT01047345
- outcome key
- om-0002
- source section id
- NCT01047345-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Who Experience a Systemic AE - Base Study
- endpoint definition
- An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
- time origin
- up to 14 days after any vaccination - Base Study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 vaccination and had available follow-up data.
- 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
- NCT01047345
- outcome key
- om-0003
- source section id
- NCT01047345-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study
- endpoint definition
- An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
- time origin
- up to 14 days after any vaccination - Base Study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 vaccination and had available follow-up data.
- 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
- NCT01047345
- outcome key
- om-0004
- source section id
- NCT01047345-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study
- endpoint definition
- An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" is defined as a vaccine-related SAE.
- time origin
- Up to 7 months - Base Study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 vaccination and had available follow-up data.
- 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
- NCT01047345
- outcome key
- om-0005
- source section id
- NCT01047345-om-0005
- source outcome index
- 5
- endpoint
- Percentage of Participants Who Experience a Severe Injection-site AE - Base Study
- endpoint definition
- An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter \>2 inches (\>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.
- time origin
- up to 5 days after any vaccination - Base Study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 vaccination and had available follow-up data.
- 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
- NCT01047345
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 9vHPV Vaccine - Base Study
- regimen
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- analyzed count
- 608
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo - Base Study
- regimen
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- analyzed count
- 305
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 9vHPV Vaccine - Base Study
- regimen
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- analyzed count
- 604
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo - Base Study
- regimen
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- analyzed count
- 304
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 9vHPV Vaccine - Base Study
- regimen
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- analyzed count
- 608
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo - Base Study
- regimen
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- analyzed count
- 305
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0003
- arm key
- OG000
- arm label
- 9vHPV Vaccine - Base Study
- regimen
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- analyzed count
- 608
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo - Base Study
- regimen
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- analyzed count
- 305
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0004
- arm key
- OG000
- arm label
- 9vHPV Vaccine - Base Study
- regimen
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- analyzed count
- 608
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo - Base Study
- regimen
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- analyzed count
- 305
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0005
- arm key
- OG000
- arm label
- 9vHPV Vaccine - Base Study
- regimen
- Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
- analyzed count
- 608
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo - Base Study
- regimen
- Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
- analyzed count
- 305
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01047345-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-cervical-cancer
- nct id
- NCT01047345
- harm key
- EG000
- source section id
- NCT01047345-ae
- event group key
- EG000
- event group label
- 9vHPV Vaccine - Base Study
- serious affected
- 3
- serious at risk
- 608
- other affected
- 566
- other at risk
- 608
- frequency threshold
- 5
- collection period
- Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
- event definition
- Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
- 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
- NCT01047345
- harm key
- EG001
- source section id
- NCT01047345-ae
- event group key
- EG001
- event group label
- Placebo - Base Study
- serious affected
- 3
- serious at risk
- 305
- other affected
- 197
- other at risk
- 305
- frequency threshold
- 5
- collection period
- Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
- event definition
- Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
- 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
- NCT01047345
- harm key
- EG002
- source section id
- NCT01047345-ae
- event group key
- EG002
- event group label
- 9vHPV Vaccine - Extension Study
- serious affected
- 2
- serious at risk
- 99
- other affected
- 0
- other at risk
- 99
- frequency threshold
- 5
- collection period
- Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
- event definition
- Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
- 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