NCT05934890进行中（未招募）3 期
A Phase 3, Randomized, Blinded, Active-controlled Study to Evaluate the Immunogenicity and Safety of Walvax's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) as Compared to Pfizer's 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Co-administered With EPI Vaccines at 2, 4, and 12-15 Months of Age, to Healthy Infants in Indonesia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
- 试验地点
- 4
- 主要终点
- Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
研究概览
简要总结
The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT) as compared to Pfizer's 13-valent pneumococcal conjugate vaccine (PCV13) when co-administered with local EPI Vaccines at 2, 4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-TT as compared to PCV13 one month after the booster 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
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants must meet ALL the following inclusion criteria for enrollment in the study, at the time of the screening:
- •Healthy infants based on medical history and clinical assessment.
- •Age of 6-8 weeks at enrolment. Infants will be eligible since the day they reach 6 weeks of age and until 8 weeks of age included.
- •Body weight at enrollment ≥3.5 kg.
- •Infant's parent(s) or legal guardian(s) must be able and willing to provide voluntary written/thumb-printed informed consent for the infant to participate in the study.
- •Infant's parent(s) or legal guardian(s) must be able to comprehend and comply with study requirements and procedures and must be willing and able to return or make themselves available for all scheduled follow-up visits.
- •Infant's parents must have a readily identifiable place of residence in the study area, be available for the duration of trial participation, and have means of telephone contact.
排除标准
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Use of any investigational medicinal product prior to randomization or planned use of such a product during the period of study participation.
- •History of S. pneumoniae infection as confirmed by medical enquiry or as confirmed by laboratory testing if available.
- •Participant has fever (axillary temperature ≥ 37.5℃) within 24 hours prior to the 1st dose of vaccination; (If the subject does not meet the criteria, the visit may be rescheduled when the criteria are met.)
- •The infant who are children in care, preterm and low-birth-weight(Preterm infants have a gestational age below 37 weeks at birth and low-birth-weight infants have a birth weight below 2.5 kg).
- •History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the 2 study vaccines. This includes all components of the EPI vaccines.
- •History of anaphylactic shock.
- •Any abnormal vital sign.
- •Any moderate or severe acute illness.
- •History of administration of a non-study vaccine within 30 days prior to administration of study vaccine, other than EPI vaccinations (Note: EPI vaccines other than that stipulated in the study must be given at least 14 days prior to the investigational vaccine.)
- •Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for 14 days at a dose of 20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids within indicated dosage are permitted.
- •Administration of immunoglobulins and/or any blood products or anticipation of such administration during the study period.
- •History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factor deficiencies, severe anemia at birth).
- •History of suspected primary immunodeficiency.
- •History of meningitis, seizures or any neurological disorder.
- •A family history of congenital or hereditary immunodeficiency.
- •The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel.
- •Any medical or social condition that in the opinion of the investigator may compromise the well-being of the study participant, interfere with the study objectives, pose a risk to the study participant, or prevent the study participant from completing the study follow-up.
结局指标
主要结局
Immunogenicity and non-inferiority as measured by serotype-specific IgG GMC
时间窗: 1 month after the booster dose
Serotype-specific IgG GMCs
Immunogenicity and non-inferiority as measured by serotype-specific IgG
时间窗: 1 month after the booster dose
Percentage of infants with serotype-specific IgG concentrations ≥0.35 μg/mL
次要结局
- Solicited local and systemic adverse events after each dose(within 30 min and 7 days after each dose)
- Immune response to primary series as measured by serotype-specific IgG(1 month after the 2nd dose)
- Functional antibody responses as measured by serotype-specific OPA geometric mean titers (GMTs)(baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose)
- Immune persistence as measured by serotype-specific IgG(12-15 months of age, before the booster dose)
- Immune persistence as measured by serotype-specific IgG GMC(12-15 months of age, before the booster dose)
- Serious adverse events throughout the study(from dose 1 until 6 months after booster dose)
- Immune response to primary series as measured by serotype-specific IgG GMC(1 month after the 2nd dose)
- Unsolicited adverse events after each dose(within 30 days after each dose)
- Functional antibody responses as measured by serotype-specific OPA titer(baseline, 1 month after the 2nd dose, before the booster dose, and 1 month after the booster dose)
研究者
研究点 (4)
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