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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHCA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab + Boostrix® + Pneumovax®23 | Experimental | Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2. |
|
| Boostrix® + Pneumovax®23 | Other | Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Drug | Administered by SQ injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of >=1.0 (International Unit (IU) and a >=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is <=1.0 at baseline OR a >=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is > 1.0 IU at baseline. Responder to the pneumococcal vaccine is defined as a >=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against >50% of the 23 serotypes. | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Daytona Beach | Florida | 32117 | United States | ||
| Covance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29116597 | Derived | Gomez EV, Bishop JL, Jackson K, Muram TM, Phillips D. Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants. BioDrugs. 2017 Dec;31(6):545-554. doi: 10.1007/s40259-017-0249-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixekizumab + Boostrix® + Pneumovax®23 | Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. |
| FG001 | Boostrix® + Pneumovax®23 | Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixekizumab + Boostrix® + Pneumovax®23 | Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. |
| BG001 | Boostrix® + Pneumovax®23 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations | Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of >=1.0 (International Unit (IU) and a >=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is <=1.0 at baseline OR a >=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is > 1.0 IU at baseline. Responder to the pneumococcal vaccine is defined as a >=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against >50% of the 23 serotypes. | All randomized participants who completed the study. | Posted | Number | percentage of participants | Week 6 |
|
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All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixekizumab + Boostrix® + Pneumovax®23 | Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | (800) 545-5979 |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
| C505143 | Boostrix |
| D013745 | Tetanus Toxoid |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Boostrix® | Drug | Administered by IM injection |
|
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| Pneumovax®23 | Drug | Administered by IM injection |
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| Evansville |
| Indiana |
| 47710 |
| United States |
| Covance | Dallas | Texas | 75247 | United States |
| Withdrawal by Subject |
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| Adverse Event |
|
Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Boostrix® + Pneumovax®23 | Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. |
|
|
|
| 0 |
| 41 |
| 1 |
| 41 |
| EG001 | Boostrix® + Pneumovax®23 | Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2. | 0 | 42 | 0 | 42 |
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| D022541 |
| Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |