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Cancer Vaccine

AFX3772 Vaccine for Pneumococcal Infections

Phase 2
Recruiting
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
4,764 Previous Clinical Trials
8,104,728 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
~63 spots leftby Jul 2026
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