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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Vaccine | Experimental | Eligible girls were offered 3 doses of the HPV vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine (Gardasil) | Biological | HPV Vaccine Administration: According to the CDC, Gardasil should be delivered through a series of three intra-muscular injections over a six-month period. The second and third doses should be given two and six months after the first dose. The vaccine can be administered at the same visit as other age-appropriate vaccines, such as Tdap, Td, MCV4, influenza, and hepatitis B vaccines. Providers should consider a 15-minute waiting period for vaccine recipients following vaccination. FDA's Approval of Gardasil (June 8, 2006) lists the following information on product Formulation: Each 0.5 mL dose of the vaccine contains: 20 mcg of HPV 6 L1 protein 40 mcg of HPV 11 L1 protein 40 mcg of HPV 16 L1 protein 20 mcg of HPV 18 L1 protein 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant) 9.56 mg of sodium chloride 0.78 mg of L-histidine 50 mcg of polysorbate 80 35 mcg of sodium borate water for injection |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers | The aim of the study to assess whether we can fully vaccinate (all 3 doses),50% of girls aged 9 -13 in the participating districts, in an 18-month period. This corresponds to 4000 girls in Thailand and 4000 in Phillipines. The study will seek to undertand if this level of population coverage (50%), can be achieved through encouraging women that recive cervical cancer screening to bring in their daughters or relatives for vaccination. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess mothers' acceptability of having their daughters receive the full course of HPV vaccine after mothers receive screening and treatment services for cervical pre-cancer | Data on mothers knowledge of the vaccine, and intention to have their daughters vaccinated will be collected for a period of 1 year (or when the target number of 700 women/guardians is reached, whatever comes first). Data will be collected on:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Llave, MD | Cancer Institute Foundation, Phillipines | Principal Investigator |
| Kobchitt Limpaphayom, MD | Chulalongkorn University, Thailand | Principal Investigator |
| Enriquito Lu, MD, MPH | Jhpiego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minglanilla | Cebu | Philippines | ||||
| Los Banos |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 1 year |
| Inform future programs that aim to introduce the HPV vaccine in the context of secondary screening for cervical cancer by determining the factors related to screened women bringing daughters for HPV vaccination and the costs of vaccine introduction | Programmatic data will be collected for the duration of the project, including but not limited to:
| 2 years |
| Quezon |
| Philippines |
| Pagbilao Health Center | Quezon | Philippines |
| Health promotion Clinic Number 11 | Nakhon Si Thammarat | Nakisron | Thailand |
| Ban Pak Poon Health Center | Nakhon Si Thammarat | Nakornsri | Thailand |
| Maharat Nakhonsithammarat Primary Care Unit | Nakhon Si Thammarat | Nakornsri | Thailand |
| Pak-Panung District Health Center | Nakhon Si Thammarat | Nakornsri | Thailand |
| Ban Yuanlae District Health Center | Ban Phon Ko | Thailand |
| Ban Mai Daeng | Nakhon Si Thammarat, Nakornsri | Thailand |
| Ban Pai Ta Health Center | Nakhon Si Thammarat, Nakornsri | Thailand |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017778 |
| Vaccines, Combined |