Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Clinical Trial Description

The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults. ;

Study Design

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02797782` - Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt	N/A
Completed	`NCT02898922` - Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C：An Open-label Control Study in China	Phase 4
Completed	`NCT03393754` - Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults	Phase 3

See also

Status

Clinical Trial

Phase

Recruiting

NCT02797782 - Study of the Long Term Efficacy of Recombinant Hepatitis B Vaccine in Nile Delta of Egypt

N/A

Completed

NCT02898922 - Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C：An Open-label Control Study in China

Phase 4

Completed

NCT03393754 - Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03408730
Study type	Interventional
Source	VBI Vaccines Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	December 14, 2017
Completion date	October 1, 2019

Lot-to-lot Consistency of Sci-B-Vac™ in Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms