A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 14
- 主要终点
- Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
研究概览
简要总结
Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria.
This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.
详细描述
Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
- •Is 12 through 15 months of age
- •- Is approximately 2 months of age
- •Both Stages:
- •Was born at full term (gestational age greater than or equal to 37 weeks)
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •- Has received a PCV dose at 10 months of age and older
- •Has received prior administration of any pneumococcal vaccine
- •Both stages:
- •Has a history of invasive pneumococcal disease (IPD)
- •Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid
研究组 & 干预措施
V118C (Stage 1)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.
干预措施: V118C (Stage 1) (Biological)
V118C (Stage 2)
Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.
干预措施: V118C (Stage 2) (Biological)
PCV20 (Stage 1)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.
干预措施: PCV20 (Stage 1) (Biological)
PCV20 (Stage 2)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.
干预措施: PCV20 (Stage 2) (Biological)
结局指标
主要结局
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
时间窗: Up to approximately 30 minutes postvaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)
时间窗: Up to approximately 12 months postvaccination
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
时间窗: Up to approximately 7 days postvaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
时间窗: Up to approximately 28 days postvaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
Stage 2: Percentage of Participants With MAAEs
时间窗: Up to approximately 12 months postdose 4
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: Up to approximately 12 months postvaccination
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
Stage 2: Percentage of Participants With Solicited Injection-Site AEs
时间窗: Up to approximately 7 days after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.
Stage 2: Percentage of Participants With Immediate AEs Following Vaccination
时间窗: Up to approximately 30 minutes after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.
Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
时间窗: Up to approximately 28 days after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.
Stage 2: Percentage of Participants With SAEs
时间窗: Up to approximately 12 months postdose 4
A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.
Stage 1: Percentage of Participants With Solicited Systemic AEs
时间窗: Up to approximately 7 days postvaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.
Stage 2: Percentage of Participants With Solicited Systemic AEs
时间窗: Up to approximately 7 days after each vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded.
次要结局
- Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations(Day 1 (Baseline) and approximately Day 30 postvaccination)
- Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3(Up to approximately 30 days postdose 3)
- Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4(Up to approximately 6 months post dose 3)
- Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)(Up to approximately 30 days post vaccination)
- Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20](Approximately Day 30 postvaccination)
- Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)(Day 1 (Baseline) and approximately Day 30 postvaccination)
- Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 4(Up to approximately 30 days postdose 4)
- Stage 2: Difference in the Response Rates [V118C minus PCV20] for Each Serotype at 30 Days Postdose 3(Up to approximately 30 days postdose 3)
- Stage 2: Difference in the Response Rates [V118C Minus PCV20] for Each Serotype at 30 Days Postdose 4(Up to approximately 30 days postdose 4)
- Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 3(Up to approximately 30 days postdose 3)
- Stage 2: GMCs of Serotype-Specific IgG at 30 Days Predose 4(Up to approximately 6 months post dose 3)
- Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 4(Up to approximately 30 days postdose 4)
- Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 3(Up to approximately 30 days postdose 3)
- Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 4(Up to approximately 30 days postdose 4)