A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
- 试验地点
- 82
- 主要终点
- Percentage of subjects with any solicited local injection site adverse events (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, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 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 approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
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 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.
- •Full-term infant at least 37 weeks gestational age at birth.
- •Afebrile for ≥72 hours with an tympanic or rectal temperature <38.0°C (<100.4°F) before receipt of study vaccine.*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours.
- •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 tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
- •Subject's parent/legal guardian has an email 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 of hepatitis B vaccine).
- •Known hypersensitivity to any vaccine.
- •Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
- •Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a <14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted.
- •History of failure to thrive or prior hospitalization for any chronic condition.
- •Subject has a bleeding disorder contraindicating IM vaccination.
- •Subject or his/her mother has documented hepatitis B surface antigen-positive test.
- •Subject has a known neurologic or cognitive behavioral disorder.
- •Subject 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 plans to receive another investigational product 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-31 High-PFS
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
干预措施: 0.5 mL of the High-PFS dose VAX-31 (Biological)
VAX-31 Low
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
干预措施: 0.5 mL of the low dose VAX-31 (Biological)
VAX-31 Mid
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
干预措施: 0.5 mL of the mid dose VAX-31 (Biological)
VAX-31 High
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
干预措施: 0.5 mL of the high dose VAX-31 (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 subjects 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
Percentage of subjects 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 subjects with any unsolicited AE within 1 month after each vaccination
时间窗: 1 months after each vaccination
Percentage of subjects with unsolicited AE
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
时间窗: 6 months after last vaccination
Percentage of subjects with MAAE
Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination
时间窗: 6 months after last vaccination
Percentage of subjects with SAE
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
时间窗: 6 months after last vaccination
Percentage of subjects with NOCI
次要结局
- Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3(1 month after Dose 3)
- Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3(1 month after Dose 3)
- Serotype-specific IgG antibody GMC 1 month after Dose 4(1 month after Dose 4)
- Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3(1 month after Dose 3)
- Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3(1 month after Dose 3)
- Serotype-specific IgG antibody GMC 1 month after Dose 4(1 month after Dose 4)