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

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ClinicalTrials.gov Identifier: NCT00956553
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Elizabeth Miller, Public Health England

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.

Condition or disease Intervention/treatment Phase
HPV Infections Biological: Cervarix Biological: Gardasil Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2013

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Measures :
  1. Determine differences in vaccine formulation and their impact on cross protection. [ Time Frame: 24 months from enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Elizabeth Miller, Prinicipal Investigator, Public Health England
ClinicalTrials.gov Identifier: NCT00956553     History of Changes
Other Study ID Numbers: HPV CSP01
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Prof. Elizabeth Miller, Public Health England:
HPV
Human Papilloma Virus
Cervical cancer vaccine

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections