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Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159834
First Posted: July 12, 2010
Last Update Posted: January 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jose Humberto Tavares Guerreiro Fregnani, PhD, Barretos Cancer Hospital
  Purpose

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.


Condition
Human Papillomavirus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Jose Humberto Tavares Guerreiro Fregnani, PhD, Barretos Cancer Hospital:

Enrollment: 1574
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gardasil, HPV infection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study included young girls enrolled in public and private schoolgirls, attending the 6th and 7th grades of the elementary school. Pregnant and breastfeeding adolescents and girls who did not attend classes (although enrolled at school) were excluded. Considering the inclusion criteria, 19 schools were candidates to the project (13 public and 6 private). The list provided by each school accounted for 1,615 girls, out of which, 41 were not eligible for the study. Thus, 1,574 girls were considered as potential candidates to the vaccination program.
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159834


Sponsors and Collaborators
Barretos Cancer Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: José H Fregnani, PhD Barretos Cancer Hospital
  More Information

Responsible Party: Jose Humberto Tavares Guerreiro Fregnani, PhD, PhD, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01159834     History of Changes
Other Study ID Numbers: Vaccine HCB 01
First Submitted: July 9, 2010
First Posted: July 12, 2010
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Jose Humberto Tavares Guerreiro Fregnani, PhD, Barretos Cancer Hospital:
HPV infection
Cervical cancer
HPV vaccine