NCT00956553

Brief Summary

This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 1, 2020

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

August 10, 2009

Last Update Submit

September 29, 2020

Conditions

HPV Infections

Keywords

HPVHuman Papilloma VirusCervical cancer vaccine

Outcome Measures

Primary Outcomes (1)

  • Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45

    18 months from enrollment

Secondary Outcomes (1)

  • Determine differences in vaccine formulation and their impact on cross protection.

    24 months from enrollment

Study Arms (2)

Cervarix

ACTIVE COMPARATOR

Three doses of Cervarix at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7.

Biological: Cervarix

Gardasil

ACTIVE COMPARATOR

Three doses of Gardasil at month 0, 1 and 6. Blood sample at month 0, 2, 7 and 12. Optional vaginal sponge sample at month 7.

Biological: Gardasil

Interventions

CervarixBIOLOGICAL

Three doses of Cervarix at month 0, 1 and 6.

Cervarix
GardasilBIOLOGICAL

Three doses of Gardasil at month 0, 1 and 6.

Gardasil

Eligibility Criteria

Age13 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 13 and 15 years at the time of the first immunisation
  • Female
  • No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
  • Written informed consent obtained from parent or guardian of subject

You may not qualify if:

  • Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill).
  • Breast-feeding mothers
  • Allergic to vaccine components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Public Health England

Stevenage, Hertfordshire, United Kingdom

Location

Professor Elizabeth Miller

Gloucester, United Kingdom

Location

Public Health England

London, NW9 5HT, United Kingdom

Location

Related Publications (4)

  • Haskins-Coulter T, Southern J, Andrews N, Miller E. Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-9. doi: 10.1080/21645515.2016.1277846. Epub 2017 Mar 20.

    PMID: 28319456RESULT

  • Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

    PMID: 41276263DERIVED

  • Godi A, Panwar K, Haque M, Cocuzza CE, Andrews N, Southern J, Turner P, Miller E, Beddows S. Durability of the neutralizing antibody response to vaccine and non-vaccine HPV types 7 years following immunization with either Cervarix(R) or Gardasil(R) vaccine. Vaccine. 2019 Apr 24;37(18):2455-2462. doi: 10.1016/j.vaccine.2019.03.052. Epub 2019 Mar 27.

    PMID: 30926298DERIVED

  • Draper E, Bissett SL, Howell-Jones R, Waight P, Soldan K, Jit M, Andrews N, Miller E, Beddows S. A randomized, observer-blinded immunogenicity trial of Cervarix((R)) and Gardasil((R)) Human Papillomavirus vaccines in 12-15 year old girls. PLoS One. 2013 May 1;8(5):e61825. doi: 10.1371/journal.pone.0061825. Print 2013.

    PMID: 23650505DERIVED

Related Links

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

human papillomavirus vaccine, L1 type 16, 18Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

October 1, 2020

Record last verified: 2018-08

Locations

GB(3)