Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
Information source: Health Protection Agency, United Kingdom
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HPV Infections
Intervention: Cervarix (Biological); Gardasil (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Dr. Elizabeth Miller Overall contact:
Elizabeth Miller, BSc MB BS FFPHM FRCPath, Phone: +44 208-327-7430, Ext: 7430, Email: Liz.Miller@hpa.org.uk
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.
Clinical Details
Official title: A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
Secondary outcome: Determine differences in vaccine formulation and their impact on cross protection.
Detailed description:
This study looks at possible cross reactivity between different HPV serotypes and both
peripheral antibodies and mucosally-secreted antibodies.
Eligibility
Minimum age: 13 Years.
Maximum age: 15 Years.
Gender(s): Female.
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
Locations and Contacts
Elizabeth Miller, BSc MB BS FFPHM FRCPath, Phone: +44 208-327-7430, Ext: 7430, Email: Liz.Miller@hpa.org.uk
Professor Elizabeth Miller, Gloucester, United Kingdom; Recruiting
Liz Miller, Phone: 020 8327 7430, Ext: 7430, Email: liz.miller@hpa.org.uk
Liz Sheasby, Phone: 020 8327 7096, Ext: 7096, Email: liz.sheasby@hpa.org.uk
Health Protection Agency, London NW9 5HT, United Kingdom; Active, not recruiting
Health Protection Agency, Stevenage, Hertfordshire, United Kingdom; Not yet recruiting
Elizabeth Miller, BSc MBBS FFPHM FRCPath, Phone: 020 8327 7430, Ext: 7430, Email: Liz.Miller@hpa.org.uk
Liz Sheasby, BSc (Hons) PgDIP, Phone: 020 8327 7096, Ext: 7096, Email: Liz.Sheasby@hpa.org.uk
Elizabeth Miller, MBBS FRCPath, Principal Investigator
Additional Information
Health Protection Agency main website. Type 'Clinical Trials' into the search bar to go to the clinical trials page.
Starting date: September 2009
Last updated: March 27, 2012
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