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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

8,000

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach

2 countries

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

March 23, 2010

Completed

7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed

9 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed

Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

March 23, 2010

Last Update Submit

October 9, 2015

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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
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
2 years

Study Arms (1)

HPV Vaccine

EXPERIMENTAL

Eligible girls were offered 3 doses of the HPV vaccine

Biological: HPV Vaccine (Gardasil)

Interventions

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

HPV Vaccine

Eligibility Criteria

Age9 Years - 13 Years

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Age 9-13 at first HPV vaccine dose
Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine
Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses

You may not qualify if:

Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine
Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose
Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia.
Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems
Girls with a bleeding disorder or currently taking anticoagulants
Girls that have received any other vaccinations in the past 4 weeks
Girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Jhpiegolead
Merck Sharp & Dohme LLCcollaborator

Study Sites (10)

Minglanilla

Cebu, Philippines

Location

Los Banos

Quezon, Philippines

Location

Pagbilao Health Center

Quezon, Philippines

Location

Health promotion Clinic Number 11

Nakhon Si Thammarat, Nakisron, Thailand

Location

Ban Pak Poon Health Center