A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
NCT ID: NCT05412030
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
388 participants
INTERVENTIONAL
2022-06-16
2025-09-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Part 1 Group 1
Infants are scheduled to receive up to three doses of 1 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as standard of care (SOC).
AFX3772
AFX3772 administered intramuscularly.
Prevnar 13
PCV13 administered intramuscularly.
Part 1 Group 2
Infants are scheduled to receive up to three doses of 2 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as SOC.
AFX3772
AFX3772 administered intramuscularly.
Prevnar 13
PCV13 administered intramuscularly.
Part 1 Group 3
Infants are scheduled to receive up to three doses of 5 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as SOC.
AFX3772
AFX3772 administered intramuscularly.
Prevnar 13
PCV13 administered intramuscularly.
Part 1 Group 4
PCV13 administered intramuscularly within 12 months.
Prevnar 13
PCV13 administered intramuscularly.
Part 2 Group 5
Infants are scheduled to receive up to three doses of 2 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV20 as SOC.
AFX3772
AFX3772 administered intramuscularly.
Prevnar 20
PCV 20 administered intramuscularly.
Part 2 Group 6
Infants are scheduled to receive up to three doses of 5 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV20 as SOC.
AFX3772
AFX3772 administered intramuscularly.
Prevnar 20
PCV 20 administered intramuscularly.
Part 2 Group 7
PCV20 administered intramuscularly within 12 months.
Prevnar 20
PCV 20 administered intramuscularly.
Interventions
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AFX3772
AFX3772 administered intramuscularly.
Prevnar 13
PCV13 administered intramuscularly.
Prevnar 20
PCV 20 administered intramuscularly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
42 Days
90 Days
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Pensacola, Florida, United States
GSK Investigational Site
Saint Augustine, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Covington, Louisiana, United States
GSK Investigational Site
Haughton, Louisiana, United States
GSK Investigational Site
Lafayette, Louisiana, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Mankato, Minnesota, United States
GSK Investigational Site
Missoula, Montana, United States
GSK Investigational Site
Hastings, Nebraska, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Cranberry Township, Pennsylvania, United States
GSK Investigational Site
Jefferson Hills, Pennsylvania, United States
GSK Investigational Site
N. Huntingdon, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Spartanburg, South Carolina, United States
GSK Investigational Site
Brownsville, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dickinson, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
Richmond, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
Syracuse, Utah, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Bayamón, , Puerto Rico
GSK Investigational Site
Caguas, , Puerto Rico
GSK Investigational Site
Ponce, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
Countries
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Other Identifiers
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2023-000423-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
219651
Identifier Type: -
Identifier Source: org_study_id
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