Last updated: 10/21/2025 12:10:19
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune response of AFX3772 Vaccine in Healthy Infants
GSK study ID
219651
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 2, Randomized, Double-blind, Multi-dose, Dose Finding Study to Evaluate the Safety, Tolerability and Immunogenicity of AFX3772 Compared With PCVs in Healthy Infants
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with solicited injection site events
Timeframe: Day 1 through Day 7 post-vaccination
Percentage of participants with solicited systemic events
Timeframe: Day 1 through Day 7 post-vaccination
Percentage of participants with AEs
Timeframe: Day 1 through Day 30
Percentage of participants with serious adverse events (SAEs)
Timeframe: Day 1 through 6 months post dose three
Secondary outcomes:
Percentage of participants with a pneumococcal serotype-specific Immunoglobulin G (IgG) concentration of greater than or equal to (>=) 0.35 μg/mL or corresponding threshold
Timeframe: 30 days post-dose two, 30 days post-dose three
Geometric mean concentration for serotype-specific IgG
Timeframe: 30 days post-dose two, 30 days post-dose three
Interventions:
Enrollment:
388
Primary completion date:
2025-18-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pneumonia, Bacterial, Pneumonia, Pneumococcal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2022 to September 2025
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
42 - 90 Days
Accepts healthy volunteers
Yes
- Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
- Had prior administration of any pneumococcal vaccine.
- Has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any components of the formulations used.
Inclusion and exclusion criteria
Inclusion criteria:
Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
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.
Had prior administration of any pneumococcal vaccine.
Trial location(s)
Location
GSK Investigational Site
South Jordan, UT, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
Jefferson Hills, PA, United States, 15025
Status
Study Complete
Location
GSK Investigational Site
Bayamon, Puerto Rico, United States, 960
Status
Study Complete
Location
GSK Investigational Site
Caguas, Puerto Rico, United States, 00725
Status
Study Complete
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
Location
GSK Investigational Site
Ponce, Puerto Rico, United States, 00716
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, UT, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
North Huntingdon, Pennsylvania, United States, 15642
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15234
Status
Study Complete
Location
GSK Investigational Site
St Augustine, FL, United States, 32086
Status
Study Complete
Location
GSK Investigational Site
Cranberry Township, PA, United States, 16006
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2025-18-09
Actual study completion date
2025-18-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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