NCT01096134

Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,000 (actual)
• Sponsor: Jhpiego · Academic / Other
• Sex: Female
• Age: 9 Years – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-03-30
• Last updated: 2015-10-12

Locations

10 sites across 2 countries: Philippines, Thailand