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

Phase 3
9 Years
26 Years
Not Enrolling
Cervical Cancer, Genital Warts

Thank you

Trial Information

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

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.

Inclusion Criteria:

- A female between, and including, 9-13 years (before 14th birthday) and 16-26 years of
age (before 27th birthday) at the time of the first vaccination.

- Healthy

- Not pregnant

- Four or less sexual partners over lifetime as reported by subject. (Sexual activity
is defined as intercourse)

- Not planning to become pregnant or likely to become pregnant

- No reported history of genital warts

- No laboratory confirmed history of cervical intraepithelial neoplasia

- No previous vaccination against HPV

- No administration of immunoglobulin and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study

- No previous anaphylactic reaction to HPV vaccine or any vaccine related component
including aluminum hydroxyphosphate sulfate and polysorbate 80

- No confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history

- No bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

- Cannot be already enrolled in any clinical trial in which investigational vaccine or
drug are being administered

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Principal Investigator

Simon Dobson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia


Canada: Health Canada

Study ID:




Start Date:

July 2007

Completion Date:

February 2008

Related Keywords:

  • Cervical Cancer
  • Genital Warts
  • HPV
  • HPV vaccine
  • Gardasil
  • Human Papillomavirus
  • vaccine
  • 2 dose versus 3
  • Uterine Cervical Neoplasms
  • Condylomata Acuminata