Infections, Papillomavirus Clinical Trial
Official title:
Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up
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
HPV-16/18 L1 VLP AS04 vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
The protocol was primarily amended for the following reasons:
- Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming
commercially available in an increasing number of countries. Therefore, the study
procedures were revised to include questions at every visit to determine if subjects
have received an HPV vaccine outside of the study.
- It was decided to offer GSK Biologicals' HPV vaccine to all subjects in the control
group at the end of the study. The HPV vaccine will be offered to these subjects based
on its local indication once the vaccine is marketed in Malaysia.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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||
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Phase 3 | |
| Completed |
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Phase 3 | |
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N/A | |
| Completed |
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Phase 3 | |
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Phase 3 | |
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Phase 2 | |
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Phase 3 | |
| Completed |
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Phase 4 | |
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Phase 3 | |
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|
Phase 4 | |
| Completed |
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Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects
|
Phase 3 | |
| Completed |
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Phase 3 | |
| Completed |
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N/A | |
| Completed |
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N/A | |
| Completed |
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N/A | |
| Completed |
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Phase 2 | |
| Completed |
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|
Phase 2 | |
| Completed |
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Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
|
Phase 1 | |
| Completed |
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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 |