Status:
COMPLETED
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pneumonia, Bacterial
Pneumococcal Infections
Eligibility:
All Genders
42-90 years
Phase:
PHASE2
Brief 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 im...
Eligibility Criteria
Inclusion
- • Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
Exclusion
- Had prior administration of any pneumococcal vaccine.
- Has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any components of the formulations used.
- Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
- Has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series.
- Has a history of microbiologically proven invasive disease caused by S. pneumoniae.
- Has received immunoglobulins.
- Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection.
- Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2025
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT05412030
Start Date
June 16 2022
End Date
September 18 2025
Last Update
October 21 2025
Active Locations (46)
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1
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
2
GSK Investigational Site
Los Angeles, California, United States, 90057
3
GSK Investigational Site
Miami, Florida, United States, 33184
4
GSK Investigational Site
Pensacola, Florida, United States, 32503