Infection Clinical Trial
Official title:
Proposal for HPV Vaccination of Women in the City of Barretos. A Pioneering Project Designed by the Pio XII Foundation - Barretos Cancer Hospital.
Verified date | January 2012 |
Source | Barretos Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Observational |
PROJECT JUSTIFICATION: Cervical cancer is a serious public health problem in Brazil, and is
the cause of significant morbidity and mortality among Brazilian women. In spite of
government efforts to improve the coverage rates of Pap tests, the disease-related incidence
and mortality rates remain high and the diagnosis is still too late.Considering that the
chronic human papillomavirus (HPV) related genital infection leads to cervical cancer
development, cervical cancer should be the target of primary prevention through vaccination.
PROJECT OBJECTIVES: This project aims to evaluate de following vaccination indicators: 1)
Program acceptance rate; 2) Vaccine coverage rate; 3) Three-dose completion rate; 4) Rescue
vaccination demand; 5) Adverse event rate;
TARGET POPULATION: Schoolgirls attending the 6th and 7th grades of elementary school (mean
age = 11.9 yo).
VACCINATION PROGRAM: The program adopted the quadrivalent vaccine because it is considered
superior to the bivalent vaccine in preventing HPV-induced lesions. In addition to
preventing the development of pre-cancer lesions and cervical cancer, the quadrivalent
vaccine has also proved to be effective in preventing condyloma, and vaginal and vulvar
cancer. The girls received the vaccines doses at their schools (school-based program) and
also at the Barretos Cancer Hospital.
RESULTS:
Program acceptance rate = 91.8% (95%CI: 87.0%-96.8%);
Vaccine coverage for 1st, 2nd and 3rd doses = 87.5% (95%CI: 82.9%-92.2%), 86.3% (95%CI:
81.8%-91.1%) and 85.0% (95%CI: 80.5%-89.7%).
Three dose completion rate = 97.2% (95%CI: 92.0%-100.0%). Reasons for dropping out of the
vaccination program included: moving out of town (17), lost during follow up (16),
guardians' decision but without a reasonable justification (3), girl refused to continue in
the program (1) and pregnancy (2). Two girls interrupted the vaccination because of adverse
events reported by the parents.
Rescue vaccination demand = 279 girls on the first dose (20.3%; 95%CI: 17.9%-22.8%), 357 on
the second dose (26.3%; 95%CI=23.6%-29.1%) and 291 on the third dose (21.7%;
95%CI=19.3%-24.4%).
Thirty adverse events were recorded or observed in 4,074 doses, providing an adverse event
rate of 0.7% (95%CI: 0.5%-1.1%). There was no severe adverse event.
Status | Completed |
Enrollment | 1574 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 10 Years to 16 Years |
Eligibility |
Inclusion Criteria:schoolgirls, attending the 6th and 7th grades of the elementary school. Exclusion Criteria:Pregnant and breastfeeding adolescents and girls who did not attend classes. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital | Merck Sharp & Dohme Corp. |
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