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Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

NCT01096134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2015-10-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Cecilia Llave, MD · Cancer Institute Foundation, Phillipines

  • Kobchitt Limpaphayom, MD · Chulalongkorn University, Thailand

  • Enriquito Lu, MD, MPH · Jhpiego

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
13 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Philippines
  • Thailand

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096134 on ClinicalTrials.gov