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Cancer Vaccine

AFX3772 Vaccine for Pneumococcal Infections

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
Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four
Awards & highlights

Study Summary

This trial is testing a new pneumococcal vaccine in infants to see if it is safe and effective.

Who is the study for?
This trial is for healthy, full-term infants around 2 months old without prior pneumococcal vaccines or immunoglobulins. Infants with fevers, bleeding issues, allergies to vaccine components, immune deficiencies, or whose mothers have HIV/hepatitis B can't participate.Check my eligibility
What is being tested?
The study compares the safety and immune response of a new vaccine AFX3772 against Prevnar 13 in preventing pneumonia. Infants receive four doses over up to 21 months. The first part tests escalating doses; the second expands to more infants at approved levels.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site (like pain or swelling), fever, irritability, and loss of appetite. More serious allergic reactions are rare but possible due to ingredients in AFX3772 or Prevnar 13.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby is about 2 months old and was born at full term.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To describe the safety and tolerability profiles of 3 different dose levels of AFX3772 compared with PCV13 with respect to the proportion of participants with AEs
Secondary outcome measures
To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3Experimental Treatment1 Intervention
5 mcg AFX3772 administered intramuscularly 4 times within 12 months
Group II: Group 2Experimental Treatment1 Intervention
2 mcg AFX3772 administered intramuscularly 4 times within 12 months
Group III: Group 1Experimental Treatment1 Intervention
1 mcg AFX3772 administered intramuscularly 4 times within 12 months
Group IV: Group 4Active Control1 Intervention
PCV13 administered intramuscularly 4 times within 12 months

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,331 Total Patients Enrolled
9 Trials studying Pneumococcal Infections
4,936 Patients Enrolled for Pneumococcal Infections
Affinivax, Inc.Industry Sponsor
3 Previous Clinical Trials
831 Total Patients Enrolled
2 Trials studying Pneumococcal Infections
705 Patients Enrolled for Pneumococcal Infections

Media Library

AFX3772 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05412030 — Phase 2
Pneumococcal Infections Research Study Groups: Group 1, Group 2, Group 3, Group 4
Pneumococcal Infections Clinical Trial 2023: AFX3772 Highlights & Side Effects. Trial Name: NCT05412030 — Phase 2
AFX3772 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412030 — Phase 2

Frequently Asked Questions

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

How many locations are participating in this research endeavor?

"The current trial is utilizing 25 different sites to enrol patients, including those based in Richmond, Saint Augustine and Madera. As such, selecting the most proximal location will help keep travel requirements at a minimum for participants."

Answered by AI

Is the enrollment criteria for this research open to individuals aged 45 and over?

"To be eligible for this clinical trial, patients must fall between 42 days to 90 days of age. An additional 14 trials are available for individuals below 18 years old and 14 more options exist for participants over 65."

Answered by AI

What is the status of FDA authorization for AFX3772?

"Our assessment at Power of AFX3772's safety is a 2. As this trial is in its second phase, there are preliminary results affirming the drug's security but no clinical evidence that it works effectively."

Answered by AI

What is the size of the patient sample undergoing this medical experiment?

"Affinivax, Inc. is responsible for this study and needs a total of 472 people that meet to the trial's criteria in order to properly execute it. As part of their efforts, they are running trials at two locations: the Pediatric Center in Richmond, Texas; and St John’s Centre for Clinical Research in Saint Augustine Florida."

Answered by AI

Does this research endeavor have any openings for participants?

"Affirmative. Clinicaltrials.gov records demonstrate that this research initiative, which was first advertised on the 16th of June 2022, is currently recruiting patients. 25 different medical centres are aiming to enrol a total of 472 individuals in the trial."

Answered by AI

Is it feasible for me to participate in this experiment?

"This clinical trial is admitting 472 infants between 42 days and 90 days old suffering from either pneumonia or pneumococcal. All participants must have been born full-term, approximately 2 months ago at the time of consenting to be included."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Pediatric Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants
2022. "A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05412030.
~66 spots leftby Jul 2026
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