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Group Low Dose_Adjuvanted for Respiratory Syncytial Virus Infection

Phase 2

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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [day 1] and 29 subsequent days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine to protect against RSV. The vaccine works by helping the body build defenses against RSV. New vaccines for RSV are in progress with promising results, although their efficacy in the presence of maternal antibodies, and their tolerance in very young babies, remain to be demonstrated.

Eligible Conditions

Respiratory Syncytial Virus Infection
Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [day 1] and 29 subsequent days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [day 1] and 29 subsequent days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [day 1] and 29 subsequent days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Humoral Immune Response in Terms of Neutralizing Antibody Titers Against RSV-serotype B

Humoral Immune Response in Terms of Neutralizing Antibody Titers Against Respiratory Syncytial Virus (RSV)-Serotype A

Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination

+4 more

Secondary study objectives

Frequency of RSVPreF3-specific Cluster of Differentiation 4+ (CD4+) T-cells Identified as Expressing at Least Two Markers

Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations

Number of Participants Reporting pIMDs up to the End of Follow-up Study Period (Month 6)

+1 more

Side effects data

From 2021 Phase 2 trial • 126 Patients • NCT04657198

60%

Injection site pain

12%

Injection site erythema

Injection site swelling

Pyrexia

Fatigue

Chills

Influenza like illness

Arthralgia

Myalgia

Limb traumatic amputation

Peripheral coldness

Dry skin

Benign prostatic hyperplasia

Oral herpes

COVID-19

Rhinitis

Glossitis

Malaise

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Medium Dose_AS01E Group

High Dose_AS01E Group

Low Dose_AS01E Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group Medium Dose_AdjuvantedExperimental Treatment1 Intervention

Participants in one of the medium dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Medium Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.

Group II: Group Low Dose_AdjuvantedExperimental Treatment1 Intervention

Participants in one of the low dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Low Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.

Group III: Group High Dose_AdjuvantedExperimental Treatment1 Intervention

Participants in one of the high dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group High Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by intramuscular (IM) injection in the non-dominant arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVPreF3 OA investigational vaccine (GSK3844766A)

2020

Completed Phase 2

~130

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