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hepatitis A inactivated virus vaccine

Phase 3

Cervical Cancer | Monoclonal antibody | Oncology |GSK plc|Last Updated: Mar 8, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment7,466

FDA Designations

No designations recorded

Clinical trial landscape

hepatitis A inactivated virus vaccine · 1 trial · 2 indications

Phase 3 1
NCT00128661Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy ParticipantsCervical Cancer
COMPLETED7,466 Analytics
PHASE3COMPLETED
Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
Cervical CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.
From Month 6 up to Month 48

CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.

Secondary Endpoints

Number of Cervical Infection With HPV16 or HPV18.
From Month 6 up to Month 48
Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type
From Month 6 up to Month 48
Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases
From Month 6 up to Month 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Cervarix GroupEXPERIMENTALSubjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix GroupACTIVE_COMPARATORSubjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Interventions

NameTypeDescription
human papillomavirus 16/18 L1 virus-like particle/AS04 vaccineBIOLOGICALThree doses of Cervarix vaccine administered on a 0, 1, 6-month schedule
hepatitis A inactivated virus vaccineBIOLOGICALThree doses of Havrix vaccine administered on a 0, 1, 6-month schedule
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Eligibility Criteria

Age Range18 Years to 25 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

DISEASE CHARACTERISTICS: •Healthy participants * Deemed to be in good general health by history and physical examination •Resident of Guanacaste Province of Costa Rica and surrounding areas * Must remain a resident for ≥ 6 months after the first study vaccination PATIENT CHARACTERISTICS: Age ...

Countries:Costa Rica
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Competitive Landscape -Cervical Cancer 65 trials

Frequently asked questions about hepatitis A inactivated virus vaccine

What is hepatitis A inactivated virus vaccine used for?

Hepatitis A inactivated virus vaccine is being studied for the prevention of cervical cancer and precancerous conditions. It is an investigational vaccine evaluated in a Phase 3 clinical trial in healthy female participants aged 18 years and older.

What does hepatitis A inactivated virus vaccine target?

Hepatitis A inactivated virus vaccine is a monoclonal antibody modality, though its specific molecular target is not disclosed. The vaccine is being investigated for its potential to prevent cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.

Who makes hepatitis A inactivated virus vaccine?

Hepatitis A inactivated virus vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is hepatitis A inactivated virus vaccine in?

Hepatitis A inactivated virus vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved for use. The Phase 3 trial has been completed.

What clinical trials is hepatitis A inactivated virus vaccine in?

Hepatitis A inactivated virus vaccine has one completed Phase 3 clinical trial, NCT00128661, titled "Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants." The trial enrolled 7,466 female participants in Costa Rica and was randomized, double-blind, and active-controlled.

Is hepatitis A inactivated virus vaccine the same as a cervical cancer vaccine?

Hepatitis A inactivated virus vaccine is being studied for the prevention of cervical cancer and precancerous conditions. In the clinical trial, it is compared against an active control, but no alternative names for the vaccine have been disclosed.