A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 149
- 试验地点
- 30
- 主要终点
- Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
研究概览
简要总结
This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 76 Days 至 104 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).
- •Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- •Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
- •Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.
排除标准
- •Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- •Significant neurological disorder or history of seizure (including simple febrile seizure).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Major known congenital malformation or serious chronic disorder.
- •Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.
结局指标
主要结局
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
时间窗: Within 7 days after vaccination 2
Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded by the participant's parents/legal guardians in an e-diary. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees (deg) Celsius (C), categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2
时间窗: Within 30 days after vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
时间窗: Within 7 days after vaccination 2
Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper and Pearson method.
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2
时间窗: Within 7 days after vaccination 2
The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2
时间窗: Within 30 minutes after vaccination 2
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
时间窗: 1 month after vaccination 2
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2
时间窗: Within 30 days after vaccination 2
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2
时间窗: Within 30 days after vaccination 2
An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population
时间窗: At baseline (before vaccination 1)
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
时间窗: At vaccination 2
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
时间窗: 1 month after vaccination 1
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 1 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
时间窗: 1 month after vaccination 2
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population
时间窗: At baseline (before vaccination 1)
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in participants who received vaccinations 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on Post Dose (PD) 2 Evaluable Immunogenicity Population (EIP) (PD2 EIP).
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
时间窗: At vaccination 2
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
时间窗: 1 month after vaccination 1
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
次要结局
- GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population(At baseline (before vaccination 1) and 1 month after vaccination 1)
- Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1(Within 7 days after vaccination 1)
- Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1(Within 30 days after vaccination 1, from 1 month after vaccination 1 to 9 months after vaccination 1 and from vaccination 1 to 9 months after vaccination 1)
- GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population(At baseline (before vaccination 1) and 1 month after vaccination 1)
- Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population(At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2)
- Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1(Within 7 days after vaccination 1)
- Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population(At baseline (before vaccination 1) and 1 month after vaccination 1)
- Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population(At baseline (before vaccination 1) and 1 month after vaccination 1)
- Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population(At baseline (before vaccination 1) and 1 month after vaccination 1)
- Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population(At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2)
- Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1(Within 7 days after vaccination 1)
- Percentage of Participants With AEs Within 30 Days After Vaccination 1(Within 30 days after vaccination 1)
- Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population(At baseline (before vaccination 1) and 1 month after vaccination 1)
- Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1(Within 30 minutes after vaccination 1)
- Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population(At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2)
- GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population(At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2)