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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil9 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil9 | Drug | Gardasil 9 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Indication of Willingness to Accept the Vaccine Based on Survey | This was established using a survey to indicate willingness to receive vaccine. | 1 day (at the time of initial recruitment /survey) |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | at baseline |
| Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. |
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Inclusion Criteria:
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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195 women consented to participate in the study. 139 consented to survey only, 56 consented to survey and Gardasil9 vaccine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gardasil9 | Gardasil9: Gardasil 9 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Vaccine |
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| ||||||||||||||||||
| Second Vaccine |
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| Third Vaccine |
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| Final Questionnaire and Blood Draw |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gardasil9 | Gardasil9: Gardasil 9 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Patient Indication of Willingness to Accept the Vaccine Based on Survey | This was established using a survey to indicate willingness to receive vaccine. | 56 patients consented to vaccine. | Posted | Count of Participants | Participants | 1 day (at the time of initial recruitment /survey) |
|
|
7 months
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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 | Gardasil9 | Gardasil9: Gardasil 9 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptoms | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haller Smith | University of Alabama at Birmingham | 205-934-4986 | hjsmith@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2021 | Sep 1, 2021 | Prot_SAP_000.pdf |
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| at 3 months |
| Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | at 6 months |
| Serum Titers of Vaccine-specific HPV Types | Immunogenicity | baseline and 7 months |
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|
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
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| Secondary | Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | 1 participant consented to vaccine and then subsequently withdrew | Posted | Count of Participants | Participants | at baseline |
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|
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| Secondary | Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | 1 patient consented to vaccine and then withdrew | Posted | Count of Participants | Participants | at 3 months |
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|
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| Secondary | Uptake of the Vaccine Doses | Those that actually received the vaccine and each time point. | 36 patients received the 2nd vaccine dose | Posted | Count of Participants | Participants | at 6 months |
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| Secondary | Serum Titers of Vaccine-specific HPV Types | Immunogenicity | This data was not collected | Posted | baseline and 7 months |
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|
| 55 |
| 0 |
| 55 |
| 1 |
| 55 |
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