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A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years

17:34 EDT 22nd July 2014 | BioPortfolio

Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Human Papillomavirus (HPV) Infection

Intervention

HPV-16/18 VLP/AS04 vaccine (Cervarix TM), Placebo

Location

GSK Investigational Site
Seoul
Korea, Republic of
138-736

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Clinical Trials [1824 Associated Clinical Trials listed on BioPortfolio]

A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females

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...

Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and th...

Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead...

Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the ut...

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and i...

PubMed Articles [17612 Associated PubMed Articles listed on BioPortfolio]

Human Papillomavirus-16/18 AS04-Adjuvanted Vaccine (Cervarix(®)): A Guide to Its Two-Dose Schedule in Girls Aged 9-14 Years in the EU.

A two-dose vaccination schedule for the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine is approved for the prevention of premalignant cervical lesions and cervical cancer causally related to...

Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: Final analysis of a long-term follow-up study up to 9.4 years post-vaccination.

HPV-023 (NCT00518336; ClinicalTrial.gov) is a long-term follow-up of an initial double-blind, randomized (1:1), placebo-controlled study (HPV-001, NCT00689741) evaluating the efficacy against human pa...

The Australian experience with the human papillomavirus vaccine.

The goal of this study was to review the current human papillomavirus (HPV) vaccine program and its outcomes to date in Australia.

Physicians' human papillomavirus vaccine recommendations, 2009 and 2011.

Physician recommendation is a key predictor of human papillomavirus (HPV) vaccine uptake. Understanding factors associated with recommendation is important for efforts to increase current suboptimal v...

Race, Ethnicity, and Income Factors Impacting Human Papillomavirus Vaccination rates.

Human papillomavirus (HPV) infection and cervical cancer disproportionately affect low-income and minority women. HPV vaccines have the potential to either reduce or exacerbate racial disparities in H...

Medical and Biotech [MESH] Definitions

A type of human papillomavirus especially associated with malignant tumors of the genital and RESPIRATORY MUCOSA.

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.

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.

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.

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)

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