Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

NCT ID: NCT01096134

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-11-30

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HPV Vaccine

Eligible girls were offered 3 doses of the HPV vaccine

Group Type: EXPERIMENTAL

HPV Vaccine (Gardasil)

Intervention Type: 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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Jhpiego

OTHER

Sponsor Role: lead

Responsible Party

Sharon Kibwana

Senior Program Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecilia Llave, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute Foundation, Phillipines

Kobchitt Limpaphayom, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University, Thailand

Enriquito Lu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Jhpiego

Locations

Minglanilla

Cebu, , Philippines

Los Banos

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

Countries

Philippines; Thailand

Other Identifiers

36448

Identifier Type: -

Identifier Source: org_study_id