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Conjugate Vaccine

VAX-24 Pneumococcal Vaccine for Infants

Phase 2
Recruiting
Research Sponsored by Vaxcyte, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male or female infant ≥42 days to ≤89 days (inclusive).
Full-term infant at least 37 weeks gestational age at birth.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after each vaccination
Awards & highlights

Study Summary

This trial will test the safety and tolerability of 4 doses of a new vaccine in infants, and compare it to a currently used vaccine.

Who is the study for?
This trial is for healthy infants aged 42 to 89 days, born full-term and without fever. They must be able to attend all visits and their guardians should consent, understand the study, and can record side effects electronically.Check my eligibility
What is being tested?
The trial tests the safety of a new pneumococcal vaccine called VAX-24 at three different dose levels compared to an existing vaccine (PCV15), given at ages 2, 4, 6, and 12-15 months alongside routine vaccines.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or swelling, fever, irritability or changes in eating habits. These are common after vaccinations but vary from one infant to another.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My infant is between 42 and 89 days old.
Select...
My baby was born full-term, after 37 weeks of pregnancy.
Select...
I can attend all required visits and follow the study's procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after each vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after each 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
Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination
Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination
Percentage of participants with any solicited systemic AE within 7 days after each vaccination
Secondary outcome measures
IgG Geometric Mean Fold Ratio (GMFR) before Dose 4 to 1 month after Dose 4
IgG antibody GMC 1 month after Dose 4
IgG antibody Geometric Mean Concentration (GMC) 1 month after Dose 3
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: VAX-24 MixedExperimental Treatment1 Intervention
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
Group II: VAX-24 MidExperimental Treatment1 Intervention
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
Group III: VAX-24 LowExperimental Treatment1 Intervention
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
Group IV: PCV20Active Control1 Intervention
Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age.

Find a Location

Who is running the clinical trial?

Vaxcyte, Inc.Lead Sponsor
3 Previous Clinical Trials
2,057 Total Patients Enrolled

Media Library

VAX-24 (Conjugate Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05844423 — Phase 2
Pneumococcal Vaccines Research Study Groups: VAX-24 Low, VAX-24 Mid, VAX-24 Mixed, PCV20
Pneumococcal Vaccines Clinical Trial 2023: VAX-24 Highlights & Side Effects. Trial Name: NCT05844423 — Phase 2
VAX-24 (Conjugate Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844423 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals being considered for participation in this trial?

"Patients that hope to be included in this medical study must be over 42 years old and below 89 years of age."

Answered by AI

Are there any known risks associated with participation in Group 1 of the experiment?

"Our assessment of Experimental: Group 1's safety came out to be a 2, as there is limited evidence available regarding its efficacy but some supporting the substance's security."

Answered by AI

What criteria must an individual meet to be eligible for this research?

"In order to be admitted into this medical trial, candidates must have had the pneumococcal vaccine and should fall between 42 Days and 89 Days of age. This clinical study is seeking approximately 800 participants."

Answered by AI

How many locations have been selected to implement this trial?

"The trial is currently available at a total of 23 sites, encompassing metropolitan areas such as Washington, Tampa and Chamblee. It's advised that participants select the closest centre to their current location in order to minimize travel requirements."

Answered by AI

Is this investigation currently recruiting participants?

"Affirmative. According to information posted on clinicaltrials.gov, this research is actively looking for participants as of April 24th 2023. The trial was first announced on March 29th 2023 and plans to recruit 800 patients from 23 different medical centres."

Answered by AI

How extensive is the participation in this research project?

"For this medical trial, a total of 800 participants that meet the pre-established qualifications are required. Patients can sign up for the study from Meridian Clinical Research in Washington D.C and Jedidiah Clinical Research in Tampa, Florida."

Answered by AI

What results are researchers aiming to achieve with this trial?

"This 7 day clinical trial will evaluate the rate of solicited systemic adverse events following each vaccination. Secondary objectives include measuring any unsolicited AE in between first and 3rd vaccinations, identifying AEs causing discontinuation within 6 months after last vaccine dose, and determining the frequency of new onset chronic illnesses over a similar time frame."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Midwest Children's Health Research Institute
Alliance for Multispecialty Research
Pediatric Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Ventavia: < 48 hours
Average response time
  • < 2 Days
~450 spots leftby Dec 2025