Official Title
Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Phase
N/ALead Sponsor
JhpiegoStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cervical CancerIntervention/Treatment
human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant ...Study Participants
8000The 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.
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
Eligible girls were offered 3 doses of the HPV vaccine
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.
