A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
Public ClinicalTrials.gov record NCT05412030. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05412030
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 388 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 42 Days to 90 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 15, 2022
- Primary completion
- Sep 17, 2025
- Completion
- Sep 17, 2025
- Last update posted
- Oct 20, 2025
2022 – 2025
United States locations
- U.S. sites
- 42
- U.S. states
- 16
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| GSK Investigational Site | Los Angeles | California | 90057 | — |
| GSK Investigational Site | Miami | Florida | 33184 | — |
| GSK Investigational Site | Pensacola | Florida | 32503 | — |
| GSK Investigational Site | Saint Augustine | Florida | 32086 | — |
| GSK Investigational Site | Tampa | Florida | 33613 | — |
| GSK Investigational Site | Nampa | Idaho | 83702 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Lexington | Kentucky | 40517 | — |
| GSK Investigational Site | Louisville | Kentucky | 40291 | — |
| GSK Investigational Site | Covington | Louisiana | 70433 | — |
| GSK Investigational Site | Haughton | Louisiana | 71037 | — |
| GSK Investigational Site | Lafayette | Louisiana | 70508 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70119 | — |
| GSK Investigational Site | Mankato | Minnesota | 56001 | — |
| GSK Investigational Site | Missoula | Montana | 59804 | — |
| GSK Investigational Site | Hastings | Nebraska | 68901 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45245 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | — |
| GSK Investigational Site | Cranberry Township | Pennsylvania | 16006 | — |
| GSK Investigational Site | Jefferson Hills | Pennsylvania | 15025 | — |
| GSK Investigational Site | N. Huntingdon | Pennsylvania | 15642 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15217 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15234 | — |
| GSK Investigational Site | Charleston | South Carolina | 29407 | — |
| GSK Investigational Site | Greenville | South Carolina | 29607 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29301 | — |
| GSK Investigational Site | Brownsville | Texas | 78520 | — |
| GSK Investigational Site | Dallas | Texas | 75230 | — |
| GSK Investigational Site | Dickinson | Texas | 77539 | — |
| GSK Investigational Site | Houston | Texas | 77065 | — |
| GSK Investigational Site | Houston | Texas | 77077 | — |
| GSK Investigational Site | Houston | Texas | 77087 | — |
| GSK Investigational Site | McAllen | Texas | 78504 | — |
| GSK Investigational Site | Richmond | Texas | 77469 | — |
| GSK Investigational Site | Layton | Utah | 84041 | — |
| GSK Investigational Site | Roy | Utah | 84067 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | — |
| GSK Investigational Site | South Jordan | Utah | 84095 | — |
| GSK Investigational Site | Syracuse | Utah | 84075 | — |
| GSK Investigational Site | Norfolk | Virginia | 68701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05412030, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05412030 live on ClinicalTrials.gov.