TriangleNCT00275262 · OUTCOME
Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Month 6 prevaccination (baseline) and Month 7 postvaccination
What was measured
Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.
Analysis population: Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
Groups in this outcome
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
Placebo
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
| Group | Source count |
|---|---|
| Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month | 8 |
| Placebo | 5 |
Reported measurements
Mean IgG1 at baseline (mcg/mL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month | 8.6 | 9.1 | Not reported | Not reported | Not reported |
| Placebo | 10.8 | 11.6 | Not reported | Not reported | Not reported |
Mean IgG1 change from baseline (mcg/mL)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month | 46.16 | 44.01 | Not reported | Not reported | Not reported |
| Placebo | 16.76 | 28.15 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.1
- value
- 8.6
- group Id
- OG001
- spread
- 11.6
- value
- 10.8
- title
- Mean IgG1 at baseline (mcg/mL)
- categories
- measurements
- group Id
- OG000
- spread
- 44.01
- value
- 46.16
- group Id
- OG001
- spread
- 28.15
- value
- 16.76
- title
- Mean IgG1 change from baseline (mcg/mL)
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
- id
- OG000
- title
- Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
- description
- Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
- reporting Status
- POSTED
- time Frame
- Month 6 prevaccination (baseline) and Month 7 postvaccination
- title
- Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
- type
- PRIMARY
- unit Of Measure
- mcg/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice