Phase 2, Randomized, Double-blind, Active-controlled Study Evaluating the Safety and Immunogenicity of IVT PCV-25 in Healthy Infants Administered With the WHO Expanded Programme on Immunization 3+0 Vaccine Schedule
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 421
- 试验地点
- 3
- 主要终点
- Percentage of participants with reactogenicity events for 7 days after Doses 1, 2, and 3
研究概览
简要总结
Phase 2 trial to evaluate safety and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in Healthy Infants
详细描述
A Phase 2 multicenter, randomized, active-controlled, double-blind study to evaluate safety and immunogenicity of a 3-dose intramuscular (IM) regimen of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Infant participants will be randomized in a 1:1:1:1 ratio to receive 3 IM injections of one IVT PCV-25 formulation or the active comparator (Prevnar 20) at 4-week intervals (at approximately 6, 10 and 14 weeks of age) with routine infant vaccines administered on the same day as IVT PCV-25/Prevnar 20.
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 56 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who meet all the following criteria may be included in the study:
- •Age 42 to 56 days, inclusive, at the time of Dose 1
- •Good general health status, as determined by medical history, physical examination, vital signs, and clinical judgment
- •Product of normal full-term pregnancy (37 to 42 weeks' gestation)
- •Birth weight ≥ 2000 g
- •Length and weight ≥ -2 standard deviations (SD) for age and sex, according to the Philippine national child growth standards (see Appendix 1)
- •Willingness of parent/guardian for the child to attend all protocol visits and to have all protocol-required procedures
- •Provision of written informed consent by legally acceptable representative
排除标准
- •Participants who meet any of the following criteria will be excluded from the study:
- •Congenital abnormality or serious chronic disorder requiring treatment or likely to affect normal growth or development
- •Any condition that may increase risk of study participation or interfere with interpretation of study results
- •Immunodeficiency or chronic administration (> 14 consecutive days) of immunosuppressant or other immune-modifying drugs (see details in Section 6.6.2), including systemic glucocorticoids, within 6 months before Day 1 (topical, intra- articular, or inhaled glucocorticoids permitted)
- •History of sepsis or pneumonia
- •History of anaphylaxis or angioedema
- •History of severe reaction to immunization
- •Known hypersensitivity to any of the ingredients in either IVT PCV-25 or Prevnar 20
- •Contraindication to any concomitant vaccine or to Prevnar 20, according to each vaccine's product information
- •Prior receipt of a licensed or investigational pneumococcal vaccine
- •Prior receipt of any diphtheria, tetanus, pertussis, Hib, or polio vaccine
- •Prior receipt of > 1 dose of HepB vaccine
- •Receipt of HepB vaccine at age ≥ 30 days
- •Receipt of an inactivated vaccine within 14 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
- •Receipt of a live vaccine within 28 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
- •Receipt of blood transfusion or blood products before Day 1 or planned receipt through Day 85
- •Receipt of any other IP before Day 1
- •Planned elective hospitalization or surgical procedure through the end of the study
- •Family member of employee of Inventprise, vendors, or research sites associated with the study
- •Any medical, psychiatric, or social condition, or occupational or other responsibility of the parent/guardian that, in the judgment of the Investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or an ability to provide informed consent
- •Temporary Delay Criteria: administration of IVT PCV-25 / Prevnar20 will be delayed for any participant who meets any of the following criteria:
- •Receipt of any inactivated vaccine within 14 days or any live vaccine within 28 days
- •Febrile illness (eg, temperature ≥ 38.0°C) or other acute illness within 48 hours
- •Any other signs or symptoms or medication use that could inhibit the proper vaccine administration of the IP or interpretation of diary data
研究组 & 干预措施
Group A (Low dose)
Infant participants will receive three 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1, 29 and 57
干预措施: Formulation B (Biological)
Group B (High dose)
Infant participants will receive three 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1, 29 and 57
干预措施: Formulation C (Biological)
Group C (Hybrid dose)
Infant participants will receive three 0.5mL dose of IVT PCV-25 Formulation D administered by intramuscular injection on Day 1, 29 and 57
干预措施: Formulation D (Biological)
Group D (Comparator)
Infant participants will receive three 0.5mL dose of Prevnar20 administered by intramuscular injection on Day 1, 29 and 57
干预措施: Prevnar20 (Biological)
结局指标
主要结局
Percentage of participants with reactogenicity events for 7 days after Doses 1, 2, and 3
时间窗: 7 days after Doses 1,2,3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, Percentage of Participants with Reactogenicity Events 7 days after Doses 1,2,3
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 3
时间窗: From Dose 1 to 28 days after Dose 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
Percentage of participants with medically attended AEs (MAAEs) from Dose 1 to 6 months after Dose 3
时间窗: From Dose 1 to 6 months after Dose 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10,and 14 weeks of age
Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 3
时间窗: From Dose 1 to 6 months after Dose 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose
时间窗: from Dose 1 to 6 months after Dose 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
次要结局
- Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose(28 days after each dose)
- Ratio of geometric mean concentrations (GMCs) of serotype-specific IgG, comparing each IVT PCV-25 formulation to Prevnar 20 at 28 days after each dose(28 days after each dose)
- Ratio of geometric mean titers (GMTs) of serotype-specific functional antibody measured by opsonophagocytic assay (OPA), comparing each IVT PCV-25 formulation to Prevnar 20 at 28 days after Dose 3(28 days after each dose)