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Conjugate Vaccine
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults
Phase 1 & 2
Waitlist Available
Research Sponsored by Vaxcyte, 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 7 days after vaccination
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new vaccine for adults, to see if it is safe and effective. The new vaccine will be compared to an existing one to see if it works better.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days after vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
+1 moreSecondary study objectives
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
Side effects data
From 2023 Phase 1 & 2 trial • 835 Patients • NCT0526645656%
Injection site pain
38%
Fatigue
38%
Muscle pain
31%
Headache
25%
Joint pain
19%
Edema
6%
Nasal congestion
6%
Rhinorrhea
6%
Upper respiratory tract infection
6%
Erythema
6%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
VAX-24 Low Dose 18-49 Yrs
VAX-24 Mid Dose 18-49 Yrs
VAX-24 Mixed Dose 18-49 Yrs
PCV20 18-49 Yrs
VAX-24 Low Dose 50-64 Yrs
VAX-24 Mid Dose 50-64 Yrs
VAX-24 Mixed Dose 50-64 Yrs
PCV20 50-64 Yrs
VAX-24 Low Dose 18-64 Yrs
VAX-24 Mid Dose 18-64 Yrs
VAX-24 Mixed Dose 18-64 Yrs
PCV20 18-64 Yrs
Awards & Highlights
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: VAX-24 Mixed DoseExperimental Treatment1 Intervention
Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
Group II: VAX-24 Mid DoseExperimental Treatment1 Intervention
Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
Group III: VAX-24 Low DoseExperimental Treatment1 Intervention
Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
Group IV: PCV20Active Control1 Intervention
Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
24 valent pneumococcal conjugate vaccine
2022
Completed Phase 2
~840
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Vaxcyte, Inc.Lead Sponsor
4 Previous Clinical Trials
2,824 Total Patients Enrolled
Clinical DevelopmentStudy DirectorVaxcyte, Inc.
36 Previous Clinical Trials
86,824 Total Patients Enrolled