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GSK Biologicals' HPV vaccine

Phase 1

Infections, Papillomavirus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 10, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment540

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' HPV vaccine · 1 trial · 1 indication

Phase 1 1
NCT00478621Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)Infections, Papillomavirus
COMPLETED540 Analytics
PHASE1COMPLETED
Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)
Infections, Papillomavirus
NCT00478621540
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Study Endpoints

Primary Endpoints

Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms
Within 7 days after each vaccine dose

Secondary Endpoints

Occurrence of serious adverse events
Up to one month after the last dose of vaccine
Occurrence, intensity and relationship to vaccination of any unsolicited symptom
Within 30 days after each vaccine dose
Occurrence of clinically relevant abnormalities in biochemical and hematological parameters
Assessed at Month 0, one month and six months after the last dose of vaccine
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -
Group FACTIVE_COMPARATOR -

Interventions

NameTypeDescription
GSK Biologicals' HPV vaccine (GSK1674330A)BIOLOGICALIntramuscular administration, 5 different formulations
Cervarix TMBIOLOGICALIntramuscular administration
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Eligibility Criteria

Age Range18 Years to 25 Years
SexFEMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * A woman whom the investigator believes can and will comply with the requirements of the protocol. * A woman between, and including, 18 and 25 years of age at the time of the first vaccination. * Written informed consent must be obtained from the subject prior to enrolment. * H...

Countries:Belgium
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Frequently asked questions about GSK Biologicals' HPV vaccine

What is GSK Biologicals' HPV vaccine used for?

GSK Biologicals' HPV vaccine is used for the prevention of cervical intraepithelial neoplasia and papillomavirus infections. It is being developed for young adolescent and adult women, with clinical trials conducted in healthy female volunteers aged 10 years and older.

Who makes GSK Biologicals' HPV vaccine?

GSK Biologicals' HPV vaccine is developed by GSK plc, which trades under the ticker GSK. The vaccine is currently in clinical development and is not yet approved for commercial use.

What phase is GSK Biologicals' HPV vaccine in?

GSK Biologicals' HPV vaccine is in Phase 1 clinical development. It has completed one Phase 1 trial and one Phase 3 trial, but it remains investigational and has not received regulatory approval.

What clinical trials is GSK Biologicals' HPV vaccine in?

GSK Biologicals' HPV vaccine has been studied in two completed trials. NCT00316706 was a Phase 3 trial in 1,245 young adolescent women across Colombia, Germany, Honduras, Panama, and Taiwan. NCT00478621 was a Phase 1 safety and immunogenicity trial in 540 young adult women in Belgium.

How does GSK Biologicals' HPV vaccine work?

GSK Biologicals' HPV vaccine is a monoclonal antibody modality designed to target human papillomavirus. It is intended to generate an immune response against HPV types 16 and 18, which are associated with cervical intraepithelial neoplasia and papillomavirus infections.