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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-000423-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Group 1 | Experimental | 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). |
|
| Part 1 Group 2 | Experimental | 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. |
|
| Part 1 Group 3 | Experimental | 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. |
|
| Part 1 Group 4 | Active Comparator | PCV13 administered intramuscularly within 12 months. |
|
| Part 2 Group 5 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFX3772 | Biological | AFX3772 administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with solicited injection site events | The assessed solicited injection site events are tenderness, redness/erythema and swelling. | Day 1 through Day 7 post-vaccination |
| Percentage of participants with solicited systemic events | The assessed solicited systemic events are irritability, fever, decrease of appetite, increased sleep, and decrease in sleep. | Day 1 through Day 7 post-vaccination |
| Percentage of participants with AEs | 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. | Day 1 through Day 30 |
| Percentage of participants with serious adverse events (SAEs) | 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. | Day 1 through 6 months post dose three |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immunological responses were assessed in terms of percentage of participants with a pneumococcal serotype-specific IgG concentration >= 0.35 μg/mL or corresponding threshold. | 30 days post-dose two, 30 days post-dose three |
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Inclusion Criteria:
• Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States | ||
| GSK Investigational Site |
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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|
| Part 2 Group 6 | Experimental | 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. |
|
| Part 2 Group 7 | Active Comparator | PCV20 administered intramuscularly within 12 months. |
|
| Prevnar 13 | Biological | PCV13 administered intramuscularly. |
|
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| Prevnar 20 | Biological | PCV 20 administered intramuscularly. |
|
|
| Geometric mean concentration for serotype-specific IgG | Immunological responses were assessed in terms of IgG GMCs and expressed as titers. | 30 days post-dose two, 30 days post-dose three |
| Los Angeles |
| California |
| 90057 |
| United States |
| GSK Investigational Site | Miami | Florida | 33184 | United States |
| GSK Investigational Site | Pensacola | Florida | 32503 | United States |
| GSK Investigational Site | Saint Augustine | Florida | 32086 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Nampa | Idaho | 83702 | United States |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40517 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40291 | United States |
| GSK Investigational Site | Covington | Louisiana | 70433 | United States |
| GSK Investigational Site | Haughton | Louisiana | 71037 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70508 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70119 | United States |
| GSK Investigational Site | Mankato | Minnesota | 56001 | United States |
| GSK Investigational Site | Missoula | Montana | 59804 | United States |
| GSK Investigational Site | Hastings | Nebraska | 68901 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45245 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| GSK Investigational Site | Cranberry Township | Pennsylvania | 16006 | United States |
| GSK Investigational Site | Jefferson Hills | Pennsylvania | 15025 | United States |
| GSK Investigational Site | N. Huntingdon | Pennsylvania | 15642 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15217 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15234 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29607 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29301 | United States |
| GSK Investigational Site | Brownsville | Texas | 78520 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Dickinson | Texas | 77539 | United States |
| GSK Investigational Site | Houston | Texas | 77065 | United States |
| GSK Investigational Site | Houston | Texas | 77077 | United States |
| GSK Investigational Site | Houston | Texas | 77087 | United States |
| GSK Investigational Site | McAllen | Texas | 78504 | United States |
| GSK Investigational Site | Richmond | Texas | 77469 | United States |
| GSK Investigational Site | Layton | Utah | 84041 | United States |
| GSK Investigational Site | Roy | Utah | 84067 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | United States |
| GSK Investigational Site | South Jordan | Utah | 84095 | United States |
| GSK Investigational Site | Syracuse | Utah | 84075 | United States |
| GSK Investigational Site | Norfolk | Virginia | 68701 | United States |
| GSK Investigational Site | Bayamón | 960 | Puerto Rico |
| GSK Investigational Site | Caguas | 00725 | Puerto Rico |
| GSK Investigational Site | Ponce | 00716 | Puerto Rico |
| GSK Investigational Site | San Juan | 00935-6528 | Puerto Rico |
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| D011008 | Pneumococcal Infections |
| D011018 | Pneumonia, Pneumococcal |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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