Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls (HPV CSP01)
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.
|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|
- 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 ]
- Determine differences in vaccine formulation and their impact on cross protection. [ Time Frame: 24 months from enrollment ] [ Designated as safety issue: No ]
|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)|
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.
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.
Three doses of Gardasil at month 0, 1 and 6.
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.
|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|
|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 firstname.lastname@example.org|
|Contact: Liz Sheasby 020 8327 7096 ext 7096 email@example.com|
|Health Protection Agency||Active, not recruiting|
|London, United Kingdom, NW9 5HT|