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 evaluating AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of three different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV20). Part 1 is the dose-escalation lead-in portion of the study, in which infants at each dose level are randomized 3:1 in sequential cohorts to receive increasing doses of AFX3772 or PCV13. In Part 2, infants are randomized to receive either one of two dose levels of AFX3772 or PCV20. On 31 October 2024, the study was placed on partial clinical hold by the U.S. Food and Drug Administration. The hold was not related to safety concerns in participants who had already received the study vaccines. As a result, enrollment was paused and no further doses of the investigational pneumococcal vaccine were administered. Participants who were already enrolled transitioned to the standard of care pneumococcal vaccine to complete their scheduled visits through post-dose 3 and subsequently completed study follow-up.
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 16, 2022 (Actual)
- Primary completion
- Sep 18, 2025 (Actual)
- Completion
- Sep 18, 2025 (Actual)
- Last update posted
- Oct 9, 2026
2022 – 2025
United States locations
- U.S. sites
- 48
- U.S. states
- 15
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| GSK Investigational Site | Gardena | California | 90247 | — |
| GSK Investigational Site | Los Angeles | California | 90057 | — |
| GSK Investigational Site | Madera | California | 93637 | — |
| GSK Investigational Site | Ontario | California | 91762 | — |
| GSK Investigational Site | Miami | Florida | 33184 | — |
| GSK Investigational Site | Pensacola | Florida | 32503 | — |
| GSK Investigational Site | Saint Augustine | Florida | 32086-5774 | — |
| GSK Investigational Site | Tampa | Florida | 33613 | — |
| GSK Investigational Site | Tampa | Florida | 33617 | — |
| 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 | 70119-7100 | — |
| GSK Investigational Site | Mankato | Minnesota | 56001 | — |
| GSK Investigational Site | Missoula | Montana | 59804 | — |
| GSK Investigational Site | Hastings | Nebraska | 68901 | — |
| GSK Investigational Site | Norfolk | Nebraska | 68701-7701 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45245 | — |
| GSK Investigational Site | Cleveland | Ohio | 44121 | — |
| 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 | 15213-3205 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15217-1212 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15234 | — |
| GSK Investigational Site | Charleston | South Carolina | 29407-4726 | — |
| 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 | 75230-2501 | — |
| GSK Investigational Site | Dickinson | Texas | 77539 | — |
| GSK Investigational Site | Houston | Texas | 77065-5470 | — |
| GSK Investigational Site | Houston | Texas | 77071 | — |
| GSK Investigational Site | Houston | Texas | 77077 | — |
| GSK Investigational Site | Houston | Texas | 77087-1122 | — |
| 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 | 84095-3211 | — |
| GSK Investigational Site | Syracuse | Utah | 84075-9645 | — |
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 9, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05412030 live on ClinicalTrials.gov.