Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention (MDI)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01096134 |
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Recruitment Status :
Completed
First Posted : March 30, 2010
Last Update Posted : October 12, 2015
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Sponsor:
Jhpiego
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Sharon Kibwana, Jhpiego
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | March 23, 2010 | |||||||||
| First Posted Date ICMJE | March 30, 2010 | |||||||||
| Last Update Posted Date | October 12, 2015 | |||||||||
| Study Start Date ICMJE | January 2011 | |||||||||
| Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers [ Time Frame: 18 months ] 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.
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention | |||||||||
| Official Title ICMJE | Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention | |||||||||
| Brief Summary | 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Cervical Cancer | |||||||||
| Intervention ICMJE | Biological: HPV Vaccine (Gardasil)
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 |
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| Study Arms ICMJE | Experimental: HPV Vaccine
Eligible girls were offered 3 doses of the HPV vaccine
Intervention: Biological: HPV Vaccine (Gardasil)
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
8000 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | November 2012 | |||||||||
| Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 9 Years to 13 Years (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Philippines, Thailand | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01096134 | |||||||||
| Other Study ID Numbers ICMJE | 36448 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Sharon Kibwana, Jhpiego | |||||||||
| Original Responsible Party | Dr. Enriquito Lu, Director of Family Planning and Reproductive Health, Jhpiego | |||||||||
| Current Study Sponsor ICMJE | Jhpiego | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Merck Sharp & Dohme LLC | |||||||||
| Investigators ICMJE |
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| PRS Account | Jhpiego | |||||||||
| Verification Date | October 2015 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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