Recent Updates
Recently added Catalysts

24 valent pneumococcal conjugate vaccine

Phase 2

Pneumococcal Vaccines | Vaccine | Infectious Disease |Vaxcyte, Inc.|Trials Updated: Oct 9, 2024

24 valent pneumococcal conjugate vaccine development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,042

FDA Designations

No designations recorded

24 valent pneumococcal conjugate vaccine clinical trials

24 valent pneumococcal conjugate vaccine · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT05297578Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older AdultsPneumococcal Vaccines
COMPLETED207 Analytics
PHASE2COMPLETED
Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults
Pneumococcal VaccinesUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
7 days after vaccination

Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site

Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
7 days after vaccination

Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination

Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination
1 month after vaccination

Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)

Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)
6 months after vaccination

Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)

Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
7 days after vaccination

Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site 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
7 days after vaccination

Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain

Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group
1 month after vaccination

Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.

Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
6 months after vaccination

Percentage of participants with SAEs and NOCIs

Secondary Endpoints

VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
1 month after vaccination
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
1 month after vaccination
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
1 month after vaccination
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VAX-24 Low DoseEXPERIMENTALParticipants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.
VAX-24 Mid DoseEXPERIMENTALParticipants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.
VAX-24 Mixed DoseEXPERIMENTALParticipants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.
PCV20ACTIVE_COMPARATORParticipants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.

Interventions

NameTypeDescription
24-Valent Pneumococcal Conjugate VaccineBIOLOGICAL0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
Pneumococcal 20-valent Conjugate VaccineBIOLOGICAL0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
24 valent pneumococcal conjugate vaccineBIOLOGICAL0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
20 valent pneumococcal conjugate vaccineBIOLOGICAL0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
Unlock Study Design Details

Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites20

Inclusion Criteria: * Male or female age 65 or older. * Able and willing to complete the informed consent process. * Available for clinical follow-up through the last study visit at 6 months after the study vaccination. * In good general health as determined by medical history, vital signs, physica...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about 24 valent pneumococcal conjugate vaccine

What is the 24-valent pneumococcal conjugate vaccine?

The 24-valent pneumococcal conjugate vaccine is an investigational vaccine designed to prevent pneumococcal disease. It is being developed by Vaxcyte, Inc. (ticker: PCVX) and is in Phase 2 clinical development. The vaccine is intended for use in adults and older adults to protect against pneumococcal infections.

What is the 24-valent pneumococcal conjugate vaccine used for?

The 24-valent pneumococcal conjugate vaccine is being studied for the prevention of pneumococcal vaccines, which are infections caused by Streptococcus pneumoniae. It is intended for use in adults, including older adults aged 65 years and above, to provide protection against pneumococcal disease.

Who makes the 24-valent pneumococcal conjugate vaccine?

The 24-valent pneumococcal conjugate vaccine is being developed by Vaxcyte, Inc., which trades under the ticker symbol PCVX. Vaxcyte is the sponsor of the clinical trials evaluating this vaccine candidate.

What phase is the 24-valent pneumococcal conjugate vaccine in?

The 24-valent pneumococcal conjugate vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. Two clinical trials have been completed, including one Phase 2 trial and one Phase 1 trial, with a total enrollment of 1,042 participants.

What clinical trials is the 24-valent pneumococcal conjugate vaccine in?

Two completed clinical trials have evaluated the 24-valent pneumococcal conjugate vaccine. NCT05297578 was a Phase 2 study in older adults aged 65 years and older, enrolling 207 participants. NCT05266456 was a Phase 1 study in adults aged 18 years and older, enrolling 835 participants. Both were conducted in the United States.

Is the 24-valent pneumococcal conjugate vaccine the same as VAX-24?

Yes, the 24-valent pneumococcal conjugate vaccine is also known as VAX-24. VAX-24 is the investigational name used by Vaxcyte, Inc. in its clinical trials, including NCT05297578 and NCT05266456, which evaluated its safety, tolerability, and immunogenicity in adults and older adults.