A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- BioNTech SE
- 入组人数
- 629
- 试验地点
- 42
- 主要终点
- Percentage of Participants With Local Reactions Within 7 Days After Dose 2
研究概览
简要总结
This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2.
- 2-dose schedule (separated by 21 days)
- At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
- In healthy adults 18 through 55 years of age
- The duration of the study for each participant will be approximately 2 months (3 visits in total)
- The study will be conducted in the United States
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.
- •Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
- •For Dose 3: Participants who received BOTH doses of the lyophilized formulation of BNT162b2 as part of the initial study.
排除标准
- •Other medical or psychiatric condition including recent (within the past year) 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.
- •Known infection with HIV, HCV, or HBV.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- •Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-
- •Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •Women who are pregnant or breastfeeding.
- •Previous vaccination with any coronavirus vaccine.
- •Receipt of medications intended to prevent COVID-
- •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), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- •Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
- •Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation / Previous participation in other studies involving study intervention containing lipid nanoparticles (LNPs).
- •Previous participation in other studies involving study intervention containing lipid nanoparticles.
- •Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
结局指标
主要结局
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
时间窗: Within 7 days after Dose 2
Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
时间窗: Within 7 days after Dose 1
Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2
时间窗: Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2
时间窗: 1 Month after Dose 2
GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
时间窗: Within 7 days after Dose 1
Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
时间窗: Within 7 days after Dose 2
Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported.
次要结局
- Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1(Baseline (Before Dose 1 on Day 1))
- Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1(From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2)