A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
- 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.
- Short title
- A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-09-18
- First posted
- 2022-06-09
- Registry last updated
- 2025-10-21
- Primary completion date
- 2025-09-18
- Start date
- 2022-06-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- GlaxoSmithKline
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05412030
- ClinicalTrials.gov ID
- NCT05412030
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Percentage of participants with solicited injection site events
Timeframe: Day 1 through Day 7 post-vaccination
The assessed solicited injection site events are tenderness, redness/erythema and swelling.
Percentage of participants with solicited systemic events
Timeframe: Day 1 through Day 7 post-vaccination
The assessed solicited systemic events are irritability, fever, decrease of appetite, increased sleep, and decrease in sleep.
Percentage of participants with AEs
Timeframe: Day 1 through Day 30
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
Percentage of participants with serious adverse events (SAEs)
Timeframe: Day 1 through 6 months post dose three
An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity. Medical or scientific judgment will be exercised by the investigator in deciding whether SAE reporting is appropriate in other situations such as significant medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
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
Immunological responses were assessed in terms of percentage of participants with a pneumococcal serotype-specific IgG concentration \>= 0.35 μg/mL or corresponding threshold.
Geometric mean concentration for serotype-specific IgG
Timeframe: 30 days post-dose two, 30 days post-dose three
Immunological responses were assessed in terms of IgG GMCs and expressed as titers.
- Sex
- All
- Age groups
- Children
- Minimum age
- 42 Days
- Maximum age
- 90 Days
- 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.
- 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.
- GSK Investigational SiteJonesboro, United States
- GSK Investigational SiteLos Angeles, United States
- GSK Investigational SiteMiami, United States
- GSK Investigational SitePensacola, United States
- GSK Investigational SiteSaint Augustine, United States
- GSK Investigational SiteTampa, United States
- GSK Investigational SiteNampa, United States
- GSK Investigational SiteBardstown, United States
- GSK Investigational SiteLexington, United States
- GSK Investigational SiteLouisville, United States
- GSK Investigational SiteCovington, United States
- GSK Investigational SiteHaughton, United States
- GSK Investigational SiteLafayette, United States
- GSK Investigational SiteNew Orleans, United States
- GSK Investigational SiteMankato, United States
- GSK Investigational SiteMissoula, United States
- GSK Investigational SiteHastings, United States
- GSK Investigational SiteCincinnati, United States
- GSK Investigational SiteTulsa, United States
- GSK Investigational SiteCranberry Township, United States
- GSK Investigational SiteJefferson Hills, United States
- GSK Investigational SiteN. Huntingdon, United States
- GSK Investigational SitePittsburgh, United States
- GSK Investigational SitePittsburgh, United States
- GSK Investigational SitePittsburgh, United States
And 21 more, listed on the interactive page.
- 2023
- 2023-000423-36