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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
629
Intramuscular injection
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Solaris Clinical Research
Meridian, Idaho, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
...and 11 more locations
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
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.
Time frame: 1 Month after Dose 2
Percentage of Participants With Local Reactions 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.
Time frame: Within 7 days after Dose 1
Percentage of Participants With Local Reactions 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.
Time frame: Within 7 days after Dose 2
Percentage of Participants With Systemic Events 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.
Time frame: Within 7 days after Dose 1
Percentage of Participants With Systemic Events 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.
Time frame: Within 7 days after Dose 2
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2
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.
Time frame: Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)
Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1
GMCs of full-length S-binding IgG levels 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.
Time frame: 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
GMFRs were defined as ratios of the geometric mean concentration of IgG at 1 month after Dose 2 to the geometric mean concentration of IgG at Baseline. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ.
Time frame: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2
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