NCT03051516 · OUTCOME
Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm
HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions · Source last updated 2024-02-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_UNITS
- Unit
- Symptom reports
- Interval / dispersion
- Not reported
- Time frame
- Up to month 36
What was measured
Will monitor safety by comparing type and frequency of AEs in the two study arms, graded according to the Food and Drug Administration criteria. Symptoms are reported at least once from any dose.
Analysis population: There were 173 incidence of reported symptoms among participants in Arm I (Vaccine) and 127 incidence of reported symptoms among participants in Arm II (Placebo). Overall, there were 91 participants in Arm I (Vaccine) and 94 participants in Arm II (Placebo) reported symptoms at least once for any dose received.
Groups in this outcome
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
Arm II (Placebo)
Patients receive placebo IM at baseline, 2 months, and 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given IM
Questionnaire Administration: Ancillary studies
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 91 |
|---|
| Arm II (Placebo) | 94 |
|---|
Analysis denominator · Symptom reports
| Group | Source count |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 173 |
|---|
| Arm II (Placebo) | 127 |
|---|
Reported measurements
Source class 1
Fever or chills
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Headache
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatigue
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Muscle aches
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Pain at injection site
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Tenderness at injection site
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
Swelling at injection site
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Medical attention/medication
Values in Symptom reports · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm II (Placebo) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- group Description
- This comparison is specific to the incidence of fever or chills.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.135
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of headache.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.640
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of fatigue.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.838
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of muscle aches.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.917
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of pain at injection site.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.005
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of tenderness at injection site.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.001
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of swelling at injection site.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.004
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of medical attention/medication required.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.133
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Description
- This comparison is specific to the incidence of fever or chills.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.135
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of headache.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.640
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of fatigue.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.838
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of muscle aches.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.917
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of pain at injection site.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.005
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of tenderness at injection site.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.001
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of swelling at injection site.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.004
- statistical Method
- Chi-squared
- group Description
- This comparison is specific to the incidence of medical attention/medication required.
- non Inferiority Comment
- Descriptive analysis
- non Inferiority Type
- OTHER
- p Value
- 0.133
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- title
- Fever or chills
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 22
- title
- Headache
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 25
- title
- Fatigue
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 17
- title
- Muscle aches
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 17
- title
- Pain at injection site
- measurements
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 31
- title
- Tenderness at injection site
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 2
- title
- Swelling at injection site
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 11
- title
- Medical attention/medication
- denom Units Selected
- Symptom reports
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 94
- units
- Participants
- counts
- group Id
- OG000
- value
- 173
- group Id
- OG001
- value
- 127
- units
- Symptom reports
- description
- Will monitor safety by comparing type and frequency of AEs in the two study arms, graded according to the Food and Drug Administration criteria. Symptoms are reported at least once from any dose.
- groups
- description
- Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
- id
- OG000
- title
- Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
- description
- Patients receive placebo IM at baseline, 2 months, and 6 months.
Laboratory Biomarker Analysis: Correlative studies
Placebo Administration: Given IM
Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Arm II (Placebo)
- param Type
- COUNT_OF_UNITS
- population Description
- There were 173 incidence of reported symptoms among participants in Arm I (Vaccine) and 127 incidence of reported symptoms among participants in Arm II (Placebo). Overall, there were 91 participants in Arm I (Vaccine) and 94 participants in Arm II (Placebo) reported symptoms at least once for any dose received.
- reporting Status
- POSTED
- time Frame
- Up to month 36
- title
- Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm
- type
- SECONDARY
- type Units Analyzed
- Symptom reports
- unit Of Measure
- Symptom reports
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