A Phase 2, Randomized, Double-blind, Multi-dose, Dose Finding Study to Evaluate the Safety, Tolerability and Immunogenicity of AFX3772 Compared With PCV13 in Healthy Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Percentage of participants with solicited injection site events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 42 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
排除标准
- •Had prior administration of any pneumococcal vaccine.
- •Has a known or suspected hypersensitivity to AFX3772, PCV13 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.
- •Has febrile illness at Visit 1.
研究组 & 干预措施
Part 1 Group 2
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.
干预措施: AFX3772 (Biological)
Part 1 Group 1
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).
干预措施: AFX3772 (Biological)
Part 1 Group 1
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).
干预措施: Prevnar 13 (Biological)
Part 1 Group 2
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.
干预措施: Prevnar 13 (Biological)
Part 1 Group 3
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.
干预措施: AFX3772 (Biological)
Part 1 Group 3
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.
干预措施: Prevnar 13 (Biological)
Part 1 Group 4
PCV13 administered intramuscularly within 12 months.
干预措施: Prevnar 13 (Biological)
Part 2 Group 5
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.
干预措施: AFX3772 (Biological)
Part 2 Group 5
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.
干预措施: Prevnar 20 (Biological)
Part 2 Group 6
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.
干预措施: AFX3772 (Biological)
Part 2 Group 6
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.
干预措施: Prevnar 20 (Biological)
Part 2 Group 7
PCV20 administered intramuscularly within 12 months.
干预措施: Prevnar 20 (Biological)
结局指标
主要结局
Percentage of participants with solicited injection site events
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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(30 days post-dose two, 30 days post-dose three)
- Geometric mean concentration for serotype-specific IgG(30 days post-dose two, 30 days post-dose three)