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MEDI-517 HPV-16/18 VLP AS04 vaccine

Phase 2

Infections, Papillomavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 16, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

MEDI-517 HPV-16/18 VLP AS04 vaccine · 1 trial · 1 indication

Phase 2 1
NCT00693615Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult FemalesInfections, Papillomavirus
COMPLETED60 Analytics
PHASE2COMPLETED
Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females
Infections, Papillomavirus
NCT0069361560
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Study Endpoints

Primary Endpoints

Solicited adverse event rates (including injection site and systemic reactions)
For 7 days after each injection
Solicited adverse event rates
For 30 days after each injection
Serious adverse event rates
From first injection through 6 months after last injection
Laboratory assessments (Chemistry and Hematology parameters)
Study Days 0, 30 and 210
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
At the time of each injection and 30 minutes after each injection
Serum ELISA titers against HPV-16 and HPV-18
30 days after the third injection

Secondary Endpoints

Serum ELISA titers against HPV-16 and HPV-18
Study Days 0, 7, 30, 60, 180, 210, and 360, and at 18, 24, 36, and 48 months
Neutralization titers against HPV-16 and HPV-18
Study Days 0, 60, 210 and 360
Inhibitory ELISAs
Study Days 0, 60, 210, and 360, and at 18, 24, 36, and 48 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALFormulation 1 of the vaccine (MEDI-517 HPV-16/18 VLP AS04 vaccine)
Group BEXPERIMENTALFormulation 2 of the vaccine \[with Al(OH)3\]
Group CEXPERIMENTALFormulation 3 of the vaccine (without adjuvant)

Interventions

NameTypeDescription
MEDI-517 HPV-16/18 VLP AS04 vaccineBIOLOGICALIM injection
MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3BIOLOGICALIM injection
MEDI-517 HPV-16/18 VLP vaccine without adjuvantBIOLOGICALIM injection
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Eligibility Criteria

Age Range18 Years to 30 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Females 18 through 30 years of age (must not have reached the 31st birthday) * Written informed consent obtained from the volunteer * Unless previously surgically sterilized, agrees to use an effective method of birth control beginning 30 days before the first study injection ...

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Frequently asked questions about MEDI-517 HPV-16/18 VLP AS04 vaccine

What is MEDI-517 HPV-16/18 VLP AS04 vaccine used for?

MEDI-517 HPV-16/18 VLP AS04 vaccine is an investigational vaccine being studied for the prevention of infections caused by human papillomavirus (HPV) types 16 and 18. It is intended for use in healthy adult females, as evaluated in a clinical trial for safety and immunogenicity.

Who makes MEDI-517 HPV-16/18 VLP AS04 vaccine?

MEDI-517 HPV-16/18 VLP AS04 vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is also known as GSK 580299 in clinical trial documentation.

What phase is MEDI-517 HPV-16/18 VLP AS04 vaccine in?

MEDI-517 HPV-16/18 VLP AS04 vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine is not currently in active clinical trials.

What clinical trials is MEDI-517 HPV-16/18 VLP AS04 vaccine in?

MEDI-517 HPV-16/18 VLP AS04 vaccine was studied in a completed Phase 2 clinical trial registered as NCT00693615. The trial, titled 'Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females,' enrolled 60 participants and was randomized, double-blind, and controlled.

Is MEDI-517 HPV-16/18 VLP AS04 vaccine the same as GSK 580299?

Yes, MEDI-517 HPV-16/18 VLP AS04 vaccine is the same as GSK 580299. The clinical trial NCT00693615 refers to the vaccine as MEDI-517 (GSK 580299), indicating that both names are used interchangeably for the same investigational vaccine.