Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With Pediatric Vaccines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 25
- 主要终点
- Percentage of participants with any solicited systemic AE within 7 days after each vaccination
研究概览
简要总结
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
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)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 42 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female infant ≥42 days to ≤89 days (inclusive).
- •Full-term infant at least 37 weeks gestational age at birth.
- •Afebrile for ≥72 hours with a rectal temperature <38.0°C (<100.4°F) or axillary temperature <37.8°C (<100.0°F) before receipt of study vaccine.*
- •Able to attend all scheduled visits and comply with the study procedures.
- •Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
- •Subject's parent/legal guardian is able to fill out an ediary of solicited AE and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
- •Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.
排除标准
- •History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- •Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
- •Known hypersensitivity to any vaccine.
- •Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
- •Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
- •History of failure to thrive.
- •Subject has a coagulation disorder contraindicating IM vaccination.
- •Subject or his/her mother have documented hepatitis B surface antigen-positive.
- •Has a known neurologic or cognitive behavioral disorder.
- •Has a known clinically significant congenital malformation or serious chronic disorder.
- •Receipt of a blood transfusion or blood products, including immunoglobulins.
- •Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
- •Any infant who cannot be adequately followed for safety according to the protocol plan.
- •Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
研究组 & 干预措施
VAX-24 Low
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
干预措施: 0.5 ml dose of 1.1 mcg VAX-24 (Biological)
VAX-24 Mid
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
干预措施: 0.5 ml dose of 2.2 mcg VAX-24 (Biological)
VAX-24 Mixed
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
干预措施: 0.5 ml dose of 2.2/4.4 mcg VAX-24 (Biological)
PCV20
Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age.
干预措施: 0.5 ml dose of PCV20 (Biological)
结局指标
主要结局
Percentage of participants with any solicited systemic AE within 7 days after each vaccination
时间窗: 7 days after each vaccination
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination
时间窗: 6 months after last vaccination
Percentage of participants with related SAE
Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination
时间窗: 7 days after each vaccination
Solicited local reactions include erythema, edema, and tenderness at the injection site
次要结局
- Percentage of subjects with any SAE within 6 months after last vaccination(6 months after last vaccination)
- IgG antibody GMC 1 month after Dose 4(1 month after Dose 4)
- Percentage of subjects achieving at least a 4-fold increase in OPA titers from pre-Dose 4 to 1 month post Dose 4(Pre-Dose 4 to 1 month after Dose 4)
- Percentage of subjects with any AE resulting in discontinuation of study within 6 months after last vaccination(6 months after last vaccination)
- Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination(6 months after last vaccination)
- Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4(1 month after Dose 4)
- IgG antibody Geometric Mean Concentration (GMC) 1 month after Dose 3(1 month after Dose 3)
- IgG Geometric Mean Fold Ratio (GMFR) before Dose 4 to 1 month after Dose 4(Pre-Dose 4 to 1 month after Dose 4)
- Percentage of subjects with any unsolicited AE within 1 month after each vaccination(1 month after each vaccination)
- Percentage of subjects with any unsolicited AE from Dose 1 through 1 month post-Dose 3(First vaccination (Dose 1) through 1 month after third vaccination (Dose 3))
- Percentage of subjects achieving at least a 4-fold increase in IgG from pre-Dose 4 to 1 month post Dose 4(Pre-Dose 4 to 1 month after Dose 4)
- Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination(6 months after last vaccination)
- Percentage of subjects achieving an anti-pneumococcal Immunoglobulin G (IgG) antibody concentration ≥0.35 mcg/mL 1 month after Dose 3(1 month after Dose 3)
- Opsonophagocytic activity (OPA) Geometric Mean Titer (GMT) 1 month after Dose 3(1 month after Dose 3)
- OPA GMT 1 month after Dose 4(1 month after Dose 4)
- OPA GMFR before Dose 4 to 1 month after Dose 4(Pre-Dose 4 to 1 month after Dose 4)