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Virus Therapy

Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A) for Viral Diseases

Phase 1

Waitlist Available

Research Sponsored by GlaxoSmithKline

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 at month 7 (i.e. 5 months after the last vaccination)

Awards & highlights

Study Summary

This trial is testing a new rabies vaccine to see if it is safe and effective. Participants will get the vaccine three times over six months.

Eligible Conditions

Viral Diseases

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at month 7 (i.e. 5 months after the last vaccination)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 7 (i.e. 5 months after the last vaccination)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 7 (i.e. 5 months after the last vaccination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants reporting medically attended AE (MAEs)

Number of participants reporting potential immune-mediated diseases (pIMDs)

Number of participants reporting serious adverse events (SAEs)

+12 more

Secondary outcome measures

Evaluation of immunogenicity in terms of Anti-rabies G IgG antibody concentrations

Evaluation of immunogenicity in terms of Rabies Virus Neutralizing Antibody (RVNA) concentrations

Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 10 months after last vaccination

+8 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592

27%

Injection site pain

25%

Pyrexia

14%

Decreased appetite

14%

Upper respiratory tract infection

14%

Diarrhea

10%

Injection site erythema

Nasopharyngitis

Irritability postvaccinal

Headache

Vomiting

Injection site induration

Myalgia

Hypersomnia

Injection site swelling

Fatigue

Crying

Injection site hemorrhage

Gastroenteritis

Pneumonia

Animal Bite

100%

80%

60%

40%

20%

Study treatment Arm

ATIV (6 to <72 Months)

TIV (6 to <72 Months)

Comparator TIV (6 to <72 Months)

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Medium dose (Md-) RG SAM (CNE) groupExperimental Treatment1 Intervention

Healthy adults,18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) medium dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Day 1.

Group II: Lowest dose (Ltd-) RG SAM (CNE) groupExperimental Treatment1 Intervention

Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lowest dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)

Group III: Lower dose (Lrd-) RG SAM (CNE) groupExperimental Treatment1 Intervention

Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lower dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)

Group IV: Low dose (Ld-) RG SAM (CNE) groupExperimental Treatment1 Intervention

In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)

Group V: RabAvert groupActive Control1 Intervention

In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm and one intramuscular injection of saline solution in the other arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).

Group VI: Saline Placebo groupPlacebo Group1 Intervention

In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive two intramuscular injections of saline placebo, one in each arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age will receive one intramuscular injections of saline placebo in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

2019

Completed Phase 1

~160

Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

2019

Completed Phase 1

~160

Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

2019

Completed Phase 1

~160

Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)

2019

Completed Phase 1

~160

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,751 Previous Clinical Trials

8,067,312 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

3,595 Previous Clinical Trials

6,143,770 Total Patients Enrolled