Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423046
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2007-01-16
Brief Title:
Immunogenicity of GlaxoSmithKline Biologicals Human Papillomavirus HPV Vaccine 580299 Versus Mercks Gardasil in Healthy Females 18-45 Years of Age
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase IIIb Observer-blind Study to Compare Immunogenicity of GSK Biologicals HPV-1618 L1AS04 Vaccine Versus Gardasil Quadrivalent Human Papillomavirus HPV-6111618 L1 VLP Recombinant Vaccine Merck Co Inc
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HPV infection has been established as a necessary cause of cervical cancer GSK Biologicals has developed an HPV-1618 L1 VLP AS04 vaccine Cervarix TM which targets the 2 most common oncogenic HPV types HPV-16 and HPV-18 found in 70 approximately of all cervical cancers Recently Mercks HPV vaccine Gardasil quadrivalent human papillomavirus HPV-6111618 L1 VLP recombinant vaccine has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females Although the GSK HPV vaccine and Gardasil have different compositions and are expected to have different efficacy profiles each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers Therefore a comparison of the immunogenicity of the two vaccines is warranted This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine HPV-1618 to Gardasil in healthy adult females 18-45 years of age
The Protocol Posting has been updated as the study will be extended by 3 additional years
The Protocol Posting has been updated as the study will be extended by 3 additional years
Detailed Description:
This Protocol Posting has been updated following Protocol Amendment 25 November 2010
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None