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2XP HEPTAVAX-II

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Trials Updated: Jul 18, 2018

2XP HEPTAVAX-II target and mechanism

ModalityMonoclonal antibody

Also known as 2XP HEPTAVAX™-II SC

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment722

FDA Designations

No designations recorded

2XP HEPTAVAX-II clinical trials

2XP HEPTAVAX-II · 1 trial · 1 indication

Phase 3 1
NCT01463683Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)Hepatitis B
COMPLETED722 Analytics
PHASE3COMPLETED
Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection
Month 7

Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.

Percentage of Participants With Injection-site Adverse Events
Up to 15 days after each vaccination

Participants were evaluated for injection-site adverse events using MedDRA version 15.1

Percentage of Participants With Pyrexia Adverse Events
Up to 15 days after each vaccination

Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
V232-2XP SCEXPERIMENTAL2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
V232-1XP SCACTIVE_COMPARATOR1XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
V232-2XP IMEXPERIMENTAL2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6

Interventions

NameTypeDescription
2XP HEPTAVAX™-II SCBIOLOGICAL -
1XP HEPTAVAX™-II SCBIOLOGICAL -
2XP HEPTAVAX™-II IMBIOLOGICAL -
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Eligibility Criteria

Age Range20 Years to 35 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: To receive the first study vaccination, Participants should meet all inclusion criteria. * Participants provide written informed consent for the trial. The Participant may also provide consent for Future Biomedical Research. However, the Participant may participate in the main ...

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Frequently asked questions about 2XP HEPTAVAX-II

What is 2XP HEPTAVAX-II used for?

2XP HEPTAVAX-II is a vaccine being developed for the prevention of hepatitis B. It is intended to induce protective immunity against hepatitis B virus infection. The vaccine is in Phase 3 clinical development and has been studied in Japanese young adults.

Who makes 2XP HEPTAVAX-II?

2XP HEPTAVAX-II is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical trial evaluating this vaccine candidate.

What phase is 2XP HEPTAVAX-II in?

2XP HEPTAVAX-II is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The vaccine remains investigational and has not been approved by the FDA.

What clinical trials is 2XP HEPTAVAX-II in?

2XP HEPTAVAX-II has been evaluated in a completed Phase 3 trial, NCT01463683, titled Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062). The trial enrolled 722 participants, was randomized, double-blind, and used an active control.

Is 2XP HEPTAVAX-II the same as 2XP HEPTAVAX-II SC?

Yes, 2XP HEPTAVAX-II SC is an alternative name for 2XP HEPTAVAX-II. The SC designation refers to the subcutaneous route of administration. Both names refer to the same hepatitis B vaccine candidate developed by Merck.