AFX3772 Vaccine for Pneumococcal Infections

Recruiting in Palo Alto (17 mi)

+58 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new vaccine called AFX3772 in healthy infants to prevent pneumococcal disease. The vaccine aims to help their immune systems recognize and fight off the bacteria that cause this disease.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My baby is about 2 months old and was born at full term.

Exclusion Criteria

I have received a pneumococcal vaccine before.

I have a bleeding condition that makes injections unsafe for me.

I have received immunoglobulin treatment.

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Treatment Details

Interventions

AFX3772 (Cancer Vaccine)
Prevnar 13 (Cancer Vaccine)

Trial OverviewThe 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.

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Group I: Group 3Experimental Treatment1 Intervention

5 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 \& Part 2 of the study.

Group II: Group 2Experimental Treatment1 Intervention

2 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 \& Part 2 of the study.

Group III: Group 1Experimental Treatment1 Intervention

1 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 of the study.

Group IV: Group 5Active Control1 Intervention

PCV20 administered intramuscularly 4 times within 12 months in Part 2 of the study.

Group V: Group 4Active Control1 Intervention

PCV13 administered intramuscularly 4 times within 12 months in Part 1 of the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

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