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Group Low Dose_Adjuvanted for Respiratory Syncytial Virus
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
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
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreSide effects data
From 2021 Phase 2 trial • 126 Patients • NCT0465719860%
Injection site pain
12%
Injection site erythema
9%
Injection site swelling
9%
Pyrexia
7%
Fatigue
5%
Chills
5%
Influenza like illness
2%
Myalgia
2%
Arthralgia
2%
Peripheral coldness
2%
Limb traumatic amputation
2%
Dry skin
2%
Benign prostatic hyperplasia
2%
Oral herpes
2%
COVID-19
2%
Rhinitis
2%
Glossitis
2%
Malaise
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Medium Dose_AS01E Group
High Dose_AS01E Group
Low Dose_AS01E Group
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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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,772 Previous Clinical Trials
8,106,777 Total Patients Enrolled
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