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A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants

NCT05412030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2025-10-21

No results posted yet for this study

Summary

This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV).

Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13.

In Part 2, infants will be randomized to receive either one of two dose levels of AFX3772 or PCV20.

Conditions

  • Pneumonia, Bacterial
  • Pneumococcal Infections
  • Pneumonia, Pneumococcal

Interventions

BIOLOGICAL

AFX3772

AFX3772 administered intramuscularly.

BIOLOGICAL

Prevnar 13

PCV13 administered intramuscularly.

BIOLOGICAL

Prevnar 20

PCV 20 administered intramuscularly.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
42 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2025-09-18
Completion
2025-09-18
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05412030 on ClinicalTrials.gov