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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00956553
First received: August 10, 2009
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
HPV Infections
Biological: Cervarix
Biological: Gardasil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 [ Time Frame: 18 months from enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine differences in vaccine formulation and their impact on cross protection. [ Time Frame: 24 months from enrollment ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: September 2009
Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cervarix
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
Three doses of Cervarix at month 0, 1 and 6.
Active Comparator: Gardasil
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
Three doses of Gardasil at month 0, 1 and 6.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956553

Locations
United Kingdom
Health Protection Agency
Stevenage, Hertfordshire, United Kingdom
Professor Elizabeth Miller
Gloucester, United Kingdom
Health Protection Agency
London, United Kingdom, NW9 5HT
Sponsors and Collaborators
Prof. Elizabeth Miller
  More Information

Additional Information:
No publications provided by Health Protection Agency, United Kingdom

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Elizabeth Miller, Prinicipal Investigator, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT00956553     History of Changes
Other Study ID Numbers: HPV CSP01
Study First Received: August 10, 2009
Last Updated: March 19, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Health Protection Agency, United Kingdom:
HPV
Human Papilloma Virus
Cervical cancer vaccine

ClinicalTrials.gov processed this record on October 01, 2014