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Spots Global Cancer Trial Database for A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

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Trial Identification

Brief Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

Official Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine

Study ID: NCT00501137

Study Description

Brief Summary: Primary objective is to determine if antibody responses to HPV types 16 \& 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination, with responses measured at Month 7.

Detailed Description: Human Papillomavirus (HPV) infection is a cause of cervical cancer. Immunogenicity, safety and efficacy in the prevention of persistent infection from HPV 16 and 18 has been proven using a 3-dose regimen in adolescent and adult females using the Quadrivalent Human Papillomavirus (Q-HPV) vaccine. The intensity of the immune response is inversely proportional to age. Immunogenicity in adolescents 9-15 years of age is 1.7 - 2 times greater than in 16-26 year old vaccine recipients. Paediatric dosing studies are necessary and prudent given limited provincial funding for new biologics acquisition and programme service delivery. A reduction from an adult 3-dose HPV vaccine regimen to a pediatric 2-dose regimen will result in increased compliance to the full vaccine series and in significant savings to the health care system both in the cost of biologics and of program delivery and administration.

Eligibility

Minimum Age: 9 Years

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Vaccine Evaluation Centre, Vancouver, British Columbia, Canada

Contact Details

Name: Simon Dobson, MD

Affiliation: University of British Columbia

Role: PRINCIPAL_INVESTIGATOR

Name: David Scheifele, MD

Affiliation: Vaccine Evaluation Centre, Vancouver

Role: STUDY_DIRECTOR

Name: Meena Dawar, MD

Affiliation: Vaccine Evaluation Centre, Vancouver

Role: STUDY_DIRECTOR

Name: Tobias Kollman, MD

Affiliation: Vaccine Evaluation Centre, Vancouver

Role: STUDY_DIRECTOR

Name: Shelly McNeil, MD

Affiliation: Centre for Vaccinology, Halifax

Role: STUDY_DIRECTOR

Name: Scott Halperin, MD

Affiliation: Centre for Vaccinology, Halifax

Role: STUDY_DIRECTOR

Name: Joanne Langley, MD

Affiliation: Centre for Vaccinology, Halifax

Role: STUDY_DIRECTOR

Name: Marc Dionne, MD

Affiliation: Centre de Recherche du CHUL (CHUQ), Quebec

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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