TriangleNCT03546842 · STUDY IN CONTEXT
Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
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
Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could 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 was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could 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 was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The only solicited systemic AE was in response to results of daily oral temperature assessments. The participant or the parent/guardian of the participant will be asked to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination on VRC. The percentage of participants that had an AE due to an elevated oral temperature \[(≥ 37.8 °C (100.0 °F)\] was summarized.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants that experience at least one SAE that was reported as at least possibly related to the study vaccine was summarized.
Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in milli Merck units/mL (mMU/mL).
Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.
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-carcinoma-in-situ
- nct id
- NCT03546842
- trial label
- Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0000
- source section id
- NCT03546842-om-0000
- source outcome index
- 0
- endpoint
- Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
- endpoint definition
- Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.
- time origin
- 4 weeks postdose 3 (Month 7)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant's immune response to 9vHPV vaccination.
- 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-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0001
- source section id
- NCT03546842-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With a Solicited Injection-site Adverse Event
- endpoint definition
- An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could 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 was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
- time origin
- Up to 5 days after any vaccination
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.
- 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-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0002
- source section id
- NCT03546842-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With a Solicited Systemic Adverse Event
- endpoint definition
- An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could 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 was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The only solicited systemic AE was in response to results of daily oral temperature assessments. The participant or the parent/guardian of the participant will be asked to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination on VRC. The percentage of participants that had an AE due to an elevated oral temperature \[(≥ 37.8 °C (100.0 °F)\] was summarized.
- time origin
- Up to 5 days after any vaccination
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.
- 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-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0003
- source section id
- NCT03546842-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants With a Vaccine-related Serious Adverse Event
- endpoint definition
- A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants that experience at least one SAE that was reported as at least possibly related to the study vaccine was summarized.
- time origin
- Up to 4 weeks postdose 3 (Month 7)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.
- 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-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0004
- source section id
- NCT03546842-om-0004
- source outcome index
- 4
- endpoint
- Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1
- endpoint definition
- Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in milli Merck units/mL (mMU/mL).
- time origin
- Day 1 (predose)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant's immune response to 9vHPV vaccination.
- 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-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0005
- source section id
- NCT03546842-om-0005
- source outcome index
- 5
- endpoint
- Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
- endpoint definition
- Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.
- time origin
- 4 weeks postdose 3 (Month 7)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant's immune response to 9vHPV vaccination.
- 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-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 9vHPV Vaccine
- regimen
- Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
- analyzed count
- 195
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03546842-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 9vHPV Vaccine
- regimen
- Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03546842-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 9vHPV Vaccine
- regimen
- Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03546842-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0003
- arm key
- OG000
- arm label
- 9vHPV Vaccine
- regimen
- Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03546842-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0004
- arm key
- OG000
- arm label
- 9vHPV Vaccine
- regimen
- Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
- analyzed count
- 195
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03546842-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-carcinoma-in-situ
- nct id
- NCT03546842
- outcome key
- om-0005
- arm key
- OG000
- arm label
- 9vHPV Vaccine
- regimen
- Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
- analyzed count
- 195
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03546842-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-carcinoma-in-situ
- nct id
- NCT03546842
- harm key
- EG000
- source section id
- NCT03546842-ae
- event group key
- EG000
- event group label
- 9vHPV Vaccine
- serious affected
- 1
- serious at risk
- 200
- other affected
- 90
- other at risk
- 200
- frequency threshold
- 5
- collection period
- Up to 4 weeks postdose 3 (Month 7)
- event definition
- Population for All-cause mortality included all enrolled participants. Population for Non-serious adverse events and serious adverse events included all participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.
- 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