Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects
Summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine as compared to the administration of either vaccine alone.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Human Papillomavirus Infection
Intervention
Engerix B, HPV Vaccine (GSK580299)
Location
GSK Investigational Site
Nijmegen
Netherlands
6525 GA
Status
Completed
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00652938
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Human Papillomavirus 18
A type of human papillomavirus especially associated with malignant tumors of the genital and RESPIRATORY MUCOSA.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Haemophilus Vaccines
Vaccines or candidate vaccines containing antigenic polysaccharides from Haemophilus influenzae and designed to prevent infection. The vaccine can contain the polysaccharides alone or more frequently polysaccharides conjugated to carrier molecules. It is also seen as a combined vaccine with diphtheria-tetanus-pertussis vaccine.
Papillomavirus Vaccines
Vaccines or candidate vaccines used to prevent PAPILLOMAVIRUS INFECTIONS. Human vaccines are intended to reduce the incidence of UTERINE CERVICAL NEOPLASMS, so they are sometimes considered a type of CANCER VACCINES. They are often composed of CAPSID PROTEINS, especially L1 protein, from various types of ALPHAPAPILLOMAVIRUS.
Rubella Vaccine
A live attenuated virus vaccine of duck embryo or human diploid cell tissue culture origin, used for routine immunization of children and for immunization of nonpregnant adolescent and adult females of childbearing age who are unimmunized and do not have serum antibodies to rubella. Children are usually immunized with measles-mumps-rubella combination vaccine. (Dorland, 28th ed)
Clinical Trials
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This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vac...
Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
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A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered...
RATIONALE: Vaccine therapy may be effective in preventing human papillomavirus infection in young participants. PURPOSE: This phase I trial is studying the side effects of vaccine therapy...
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