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Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls (HPV CSP01)

Primary Purpose

HPV Infections

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Cervarix
Gardasil
Sponsored by
Public Health England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HPV Infections focused on measuring HPV, Human Papilloma Virus, Cervical cancer vaccine

Eligibility Criteria

13 Years - 15 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Public Health England
  • Professor Elizabeth Miller
  • Public Health England

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cervarix

Gardasil

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2009
Last Updated
September 29, 2020
Sponsor
Public Health England
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1. Study Identification

Unique Protocol Identification Number
NCT00956553
Brief Title
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
Acronym
HPV CSP01
Official Title
A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health England

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infections
Keywords
HPV, Human Papilloma Virus, Cervical cancer vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervarix
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Gardasil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Cervarix
Intervention Description
Three doses of Cervarix at month 0, 1 and 6.
Intervention Type
Biological
Intervention Name(s)
Gardasil
Intervention Description
Three doses of Gardasil at month 0, 1 and 6.
Primary Outcome Measure Information:
Title
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
Time Frame
18 months from enrollment
Secondary Outcome Measure Information:
Title
Determine differences in vaccine formulation and their impact on cross protection.
Time Frame
24 months from enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Public Health England
City
Stevenage
State/Province
Hertfordshire
Country
United Kingdom
Facility Name
Professor Elizabeth Miller
City
Gloucester
Country
United Kingdom
Facility Name
Public Health England
City
London
ZIP/Postal Code
NW9 5HT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28319456
Citation
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.
Results Reference
result
PubMed Identifier
30926298
Citation
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.
Results Reference
derived
PubMed Identifier
23650505
Citation
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28319456
Description
Published study results

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Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls

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