Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls (HPV CSP01)
This study is currently recruiting participants.
Verified March 2012 by Health Protection Agency, United Kingdom
Sponsor:
Dr. Elizabeth Miller
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00956553
First received: August 10, 2009
Last updated: March 27, 2012
Last verified: March 2012
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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 ]
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956553
Contacts
| Contact: Elizabeth Miller, BSc MB BS FFPHM FRCPath | +44 208-327-7430 ext 7430 | Liz.Miller@hpa.org.uk |
| Contact: Liz Sheasby, BSc (Hons) PgDip | +44 20 8327 7096 ext 7096 | Liz.Sheasby@hpa.org.uk |
Locations
| United Kingdom | |
| Health Protection Agency | Not yet recruiting |
| Stevenage, Hertfordshire, United Kingdom | |
| Contact: Elizabeth Miller, BSc MBBS FFPHM FRCPath 020 8327 7430 ext 7430 Liz.Miller@hpa.org.uk | |
| Contact: Liz Sheasby, BSc (Hons) PgDIP 020 8327 7096 ext 7096 Liz.Sheasby@hpa.org.uk | |
| Principal Investigator: Elizabeth Miller, MBBS FRCPath | |
| Professor Elizabeth Miller | Recruiting |
| Gloucester, United Kingdom | |
| Contact: Liz Miller 020 8327 7430 ext 7430 liz.miller@hpa.org.uk | |
| Contact: Liz Sheasby 020 8327 7096 ext 7096 liz.sheasby@hpa.org.uk | |
| Health Protection Agency | Active, not recruiting |
| London, United Kingdom, NW9 5HT | |
Sponsors and Collaborators
Dr. Elizabeth Miller
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. 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 27, 2012 |
| 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 May 23, 2013