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Virus Therapy
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Salt Lake City, UT
Phase 3
Waitlist Available
Research Sponsored by VBI Vaccines Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after third vaccination (study day 196)
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
See full description
Eligible Conditions
- Hepatitis B Vaccine
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of vaccine administration and six subsequent days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of vaccine administration and six subsequent days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1)
Secondary study objectives
Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
Side effects data
From 2019 Phase 3 trial • 1607 Patients • NCT033937549%
Headache
7%
Upper respiratory tract infection
5%
Fatigue
4%
Nasopharyngitis
4%
Myalgia
3%
Back pain
3%
Diarrhoea
3%
Arthralgia
2%
Oropharyngeal pain
2%
Urinary tract infection
2%
Pain in extremity
2%
Sinusitis
2%
Hypertension
2%
Injection site pain
1%
Gastroenteritis
1%
Dizziness
1%
Influenza
1%
Muscle strain
1%
Cough
1%
Toothache
1%
Nausea
1%
Neck pain
1%
Bronchitis
1%
Respiratory rate increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Engerix-B® Hepatitis B Vaccination
Sci-B-Vac® Hepatitis B Vaccination
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Sci-B-Vac Lot C Hep B VaccinationExperimental Treatment1 Intervention
Sci-B-Vac Lot C Hepatitis B Vaccination
Group II: Sci-B-Vac Lot B Hep B VaccinationExperimental Treatment1 Intervention
Sci-B-Vac Lot B Hepatitis B Vaccination
Group III: Sci-B-Vac Lot A Hep B VaccinationExperimental Treatment1 Intervention
Sci-B-Vac Lot A Hepatitis B Vaccination
Group IV: Comparator: ENGERIX-B Hep B VaccinationActive Control1 Intervention
Active Comparator: ENGERIX-B Hepatitis B Vaccination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hepatitis B Vaccine (Recombinant)
FDA approved
Find a Location
Closest Location:Aventiv Research Inc· Columbus, OH· 1 miles
Who is running the clinical trial?
VBI Vaccines Inc.Lead Sponsor
11 Previous Clinical Trials
2,854 Total Patients Enrolled
Francisco Diaz-Mitoma, MD, PhDStudy DirectorVBI Vaccines
1 Previous Clinical Trials
1,607 Total Patients Enrolled