Infections, Papillomavirus Clinical Trial
Official title:
Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01290393 -
Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada
|
||
Completed |
NCT00369824 -
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
|
Phase 3 | |
Completed |
NCT00345878 -
Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
|
Phase 3 | |
Completed |
NCT00947115 -
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
|
Phase 3 | |
Completed |
NCT01187927 -
Drug Use Investigation for Cervarix®
|
N/A | |
Completed |
NCT01190176 -
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
|
Phase 3 | |
Completed |
NCT00359619 -
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
|
Phase 2 | |
Completed |
NCT00196937 -
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
|
Phase 3 | |
Completed |
NCT00534638 -
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
|
Phase 4 | |
Completed |
NCT00250276 -
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
|
Phase 3 | |
Completed |
NCT01031069 -
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
|
Phase 4 | |
Completed |
NCT00996125 -
Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects
|
Phase 3 | |
Completed |
NCT00779766 -
Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
|
Phase 3 | |
Completed |
NCT01953822 -
Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom
|
N/A | |
Completed |
NCT01153906 -
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
|
N/A | |
Completed |
NCT01207999 -
Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer
|
N/A | |
Completed |
NCT00693615 -
Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females
|
Phase 2 | |
Completed |
NCT00693966 -
Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females
|
Phase 2 | |
Completed |
NCT00541970 -
Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
|
Phase 1 | |
Completed |
NCT01627561 -
Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old
|
Phase 3 |