CClinicalTrials.gg
Sign In
CompletedNCT00501137BCGov-01Updated Apr 10, 2015

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

A Phase 3 interventional study of HPV (Human Papillomavirus) Vaccine in Cervical Cancer and Genital Warts, sponsored by Simon Dobson. Completed at 1 site in Canada. Open to female participants aged 9 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-10.

Sponsored by Simon Dobson · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
830
Allocation
Randomized
Ages
9 Years to 26 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Cancer
  • Genital Warts

Browse trials for

Keywords

  • HPV
  • HPV vaccine
  • Gardasil
  • Human Papillomavirus
  • vaccine
  • 2 dose versus 3
03

In context

Condylomata Acuminata

94 studies on the registry are indexed under Condylomata Acuminata; 7 are open to participants now.

This study's enrollment of 830 is above the median of 140 across 77 interventional studies indexed under Condylomata Acuminata.

Browse Condylomata Acuminata studies →

Lead sponsor

This is the only study on the registry with Simon Dobson as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 26 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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 period
  • 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

Exclusion criteria

Exclusion Criteria

  • Pregnant
  • Female planning to become pregnant or likely to become pregnant (as determined by the investigator) during the study duration Part 1 (0-7 months)
  • Reported history of genital warts
  • Laboratory confirmed history of cervical intraepithelial neoplasia
  • Greater than four lifetime sexual partners involving sexual intercourse
  • Previous vaccination against HPV
  • 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 period
  • A previous anaphylactic reaction to HPV vaccine or any vaccine related component including aluminum hydroxyphosphate sulfate and polysorbate 80
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history (e.g. HIV infection, genetic defect, immunosuppressive therapy). *Chronic administration (defined as more than 14 days) of immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study period is exclusionary (corticosteroid use - immune-modifying level is ≥0.5 mg/kg/day; inhaled or topical steroids are acceptable).
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopaenia, coagulation disorder, anti-coagulant therapy).
  • Enrollment in any clinical trial in which investigational vaccine or drug are being administered
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
830 participants (actual)

Study arms

  • Active comparator
    16-26 year olds 3 doses HPV Vaccine

    Group 3 - 16-26 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0, 2, 6 mths

    Biological: HPV (Human Papillomavirus) Vaccine

  • Active comparator
    3 dose 9-13 HPV Vaccine

    Group 2 - 9-13 year olds receiving 3 doses HPV (Human Papillomavirus) Vaccine at 0,2,6 mths

    Biological: HPV (Human Papillomavirus) Vaccine

  • Active comparator
    2 dose 9-13 yrs HPV Vaccine

    Group 1 9-13 year olds 2 doses HPV (Human Papillomavirus) Vaccine at 0 and 6 mths

    Biological: HPV (Human Papillomavirus) Vaccine

Interventions

  • BiologicalHPV (Human Papillomavirus) Vaccine

    HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm

    Also known as: Gardasil, Q-HPV, HPV Vaccine

06

What researchers measure

Primary outcomes

  1. Primary Objective Part 1

    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

    Time frame: Measured after Month 7

  2. Primary Objective Part 2

    To compare the serum antibody responses to HPV 6, 11, 16 \& 18 at months 18, 24 and 36 in 2-dose adolescent arm, 3-dose adolescent arm and 3-dose adult arm of the study.

    Time frame: At 18, 24 and 36mths post dose 1

  3. Primary Objective Part 2

    To evaluate the memory B cell and T helper cell mediated immune response to Q-HPV vaccine in the 2-dose adolescent, 3-dose adolescent and 3-dose adult arms

    Time frame: Measured at 36 mths

Secondary outcomes

  1. Secondary Objective Part 1 & 2 - Antibody responses 2 doses between 9-13 vs 16-26

    To demonstrate that 2-doses of Q-HPV vaccine administered to 9-13 year old females produces a serum antibody response to HPV 6 and 11 that is similar to the response seen in 16-26 year olds

    Time frame: Measured at 7, 18,24 and 36 mths

  2. Secondary Objective Part 1 & 2 - HPV 16 and 18 2 doses versus 3

    To evaluate the antibody responses to HPV 16 and 18 in 9-13 year old females after a 2-dose versus a 3-dose Q-HPV regimen

    Time frame: Measured at 7,18,24 and 36 mths

  3. Secondary Objective Part 1 seroconversion rates

    To evaluate seroconversion rates to HPV 6, 11, 16, and 18

    Time frame: Measured at 7 mths

  4. Secondary Objective Part 1 Memory Response

    To evaluate the memory B cell and T helper cell mediated immune response to Q-HPV vaccine in the 2-dose adolescent, 3-dose adolescent and 3-dose adult arms

    Time frame: Measured at 7 mths

07

Study locations

1 site
  • Vaccine Evaluation Centre
    Vancouver, British Columbia, Canada
08

References and documents

Publications

  • Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, Langley JM, Bettinger JA, Singer J, Money D, Miller D, Naus M, Marra F, Young E. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013 May 1;309(17):1793-802. doi: 10.1001/jama.2013.1625. PubMed 23632723 ↗
  • Krajden M, Cook D, Yu A, Chow R, Su Q, Mei W, McNeil S, Money D, Dionne M, Palefsky J, Karunakaran K, Kollmann T, Ogilvie G, Petric M, Dobson S. Assessment of HPV 16 and HPV 18 antibody responses by pseudovirus neutralization, Merck cLIA and Merck total IgG LIA immunoassays in a reduced dosage quadrivalent HPV vaccine trial. Vaccine. 2014 Jan 23;32(5):624-30. doi: 10.1016/j.vaccine.2013.09.007. Epub 2013 Sep 19. PubMed 24055350 ↗
  • Krajden M, Cook D, Yu A, Chow R, Mei W, McNeil S, Money D, Dionne M, Karunakaran KP, Palefsky JM, Dobson S, Ogilvie G, Petric M. Human papillomavirus 16 (HPV 16) and HPV 18 antibody responses measured by pseudovirus neutralization and competitive Luminex assays in a two- versus three-dose HPV vaccine trial. Clin Vaccine Immunol. 2011 Mar;18(3):418-23. doi: 10.1128/CVI.00489-10. Epub 2011 Jan 19. PubMed 21248158 ↗
  • Smolen KK, Gelinas L, Franzen L, Dobson S, Dawar M, Ogilvie G, Krajden M, Fortuno ES 3rd, Kollmann TR. Age of recipient and number of doses differentially impact human B and T cell immune memory responses to HPV vaccination. Vaccine. 2012 May 21;30(24):3572-9. doi: 10.1016/j.vaccine.2012.03.051. Epub 2012 Mar 31. PubMed 22469863 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00501137
Lead sponsor
Simon Dobson
Collaborators
Ministry of Health, British Columbia
Responsible party
Simon Dobson (Associate Clinical Professor, University of British Columbia) — Sponsor-investigator
First posted
Jul 13, 2007
Start date
Jul 2007
Primary completion
Feb 2008
Completion
Dec 2010
Last update
Apr 10, 2015

Study contacts

Simon Dobson, MD
principal investigator · University of British Columbia
David Scheifele, MD
study director · Vaccine Evaluation Centre, Vancouver
Meena Dawar, MD
study director · Vaccine Evaluation Centre, Vancouver
Tobias Kollman, MD
study director · Vaccine Evaluation Centre, Vancouver
Shelly McNeil, MD
study director · Centre for Vaccinology, Halifax
Scott Halperin, MD
study director · Centre for Vaccinology, Halifax
Joanne Langley, MD
study director · Centre for Vaccinology, Halifax
Marc Dionne, MD
study director · Centre de Recherche du CHUL (CHUQ), Quebec

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Condylomata Acuminata→

Start the discussion