COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
Brief summary
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: * As a 2-dose (separated by 21 days) schedule; * At various different dose levels in Phase 1; * As a booster; * In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age \[stratified as 12-15, 16-55 or \>55 years of age\]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days. To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.
Interventions
BIOLOGICALBNT162b1
Intramuscular injection
BIOLOGICALBNT162b2
Intramuscular injection
OTHERPlacebo
Intramuscular injection
BIOLOGICALBNT162b2SA
Intramuscular injection
Sponsors
BioNTech SE
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization. Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment. Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization. Note that participants \<18 years of age cannot be enrolled in the EU. * Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. * Boostability and protection-against-VOCs existing participant subset only: Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window. * Capable of giving personal signed informed consent
Exclusion criteria
* 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. * Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (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). * Receipt of medications intended to prevent COVID 19. * 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 19 * Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors: * Hypertension * Diabetes mellitus * Chronic pulmonary disease * Asthma * Current vaping or smoking * History of chronic smoking within the prior year * BMI \>30 kg/m2 * Anticipating the need for immunosuppressive treatment within the next 6 months * Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. * 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. * Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. * Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids. * 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 through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation. * Previous participation in other studies involving study intervention containing lipid nanoparticles. * Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. * Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. * Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit. * Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention. * Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1 | Within 7 days after Dose 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants 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). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 1 | Within 7 days after Dose 2 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 1 | Within 7 days after Dose 1 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 hours\[h\]), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 1 | Within 7 days after Dose 2 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). |
| Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1 | From Dose 1 to 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For BNT162b1 100 mcg, participants received one dose of 100 mcg, followed by one dose of 10 mcg. |
| Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1 | From Dose 1 to 6 Months After Dose 2 | An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. For BNT162b1 100 mcg, participants received one dose of 100 mcg, followed by one dose of 10 mcg. |
| Percentage of Participants With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1 | 1 Day After Dose 1 | Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : \<0.8x lower limit of normal (LLN), Hematocrit : \<0.8x LLN, Erythrocytes : \<0.8x LLN, Ery. Mean Corpuscular Volume: \<0.9x LLN, Ery. Mean Corpuscular Hemoglobin : \<0.9x LLN Ery. Mean Corpuscular HGB Concentration : \<0.9x LLN, Platelets : \<0.5x LLN, Leukocytes : \<0.6x LLN, Lymphocytes : \<0.8x LLN, Neutrophils : \<0.8x LLN, Basophils: \>1.2x upper limit of normal (ULN), Eosinophils \>1.2x ULN, Monocytes \>1.2x ULN. Only parameters with abnormal values were reported in this outcome measure. |
| Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1 | 7 Days After Dose 1 | Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : \<0.8x LLN, Hematocrit : \<0.8x LLN, Erythrocytes : \<0.8x LLN, Ery. Mean Corpuscular Volume: \<0.9x LLN, Ery. Mean Corpuscular Hemoglobin : \<0.9x LLN Ery. Mean Corpuscular HGB Concentration : \<0.9x LLN, Platelets : \<0.5x LLN, Leukocytes : \<0.6x LLN, Lymphocytes : \<0.8x LLN, Neutrophils : \<0.8x LLN, Basophils: \>1.2x ULN, Eosinophils \>1.2x ULN, Monocytes \>1.2x ULN. Only parameters with abnormal values were reported in this outcome measure. |
| Percentage of Participants With Abnormalities in Hematology Parameters Before Dose 2: Phase 1 | Before Dose 2 | Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : \<0.8x LLN, Hematocrit : \<0.8x LLN, Erythrocytes : \<0.8x LLN, Ery. Mean Corpuscular Volume: \<0.9x LLN, Ery. Mean Corpuscular Hemoglobin : \<0.9x LLN Ery. Mean Corpuscular HGB Concentration : \<0.9x LLN, Platelets : \<0.5x LLN, Leukocytes : \<0.6x LLN, Lymphocytes : \<0.8x LLN, Neutrophils : \<0.8x LLN, Basophils: \>1.2x ULN, Eosinophils \>1.2x ULN, Monocytes \>1.2x ULN. Only parameters with abnormal values were reported in this outcome measure. |
| Percentage of Participants With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1 | 7 Days After Dose 2 | Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Abnormal parameters were determined by following criteria: Hemoglobin : \<0.8x LLN, Hematocrit : \<0.8x LLN, Erythrocytes : \<0.8x LLN, Ery. Mean Corpuscular Volume: \<0.9x LLN, Ery. Mean Corpuscular Hemoglobin : \<0.9x LLN Ery. Mean Corpuscular HGB Concentration : \<0.9x LLN, Platelets : \<0.5x LLN, Leukocytes : \<0.6x LLN, Lymphocytes : \<0.8x LLN, Neutrophils : \<0.8x LLN, Basophils: \>1.2x ULN, Eosinophils \>1.2x ULN, Monocytes \>1.2x ULN. Only parameters with abnormal values were reported in this outcome measure. |
| Percentage of Participants With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1 | 1 Day After Dose 1 | Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: \>1.5x ULN, AST: \>3.0x ULN, ALT: \>3.0x ULN, ALP: \>3.0x ULN, urea nitrogen: \>1.3x ULN, creatinine: \>1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin. |
| Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1 | 7 Days After Dose 1 | Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: \>1.5x ULN, AST: \>3.0x ULN, ALT: \>3.0x ULN, ALP: \>3.0x ULN, urea nitrogen: \>1.3x ULN, creatinine: \>1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin. |
| Percentage of Participants With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1 | Before Dose 2 | Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: \>1.5x ULN, AST: \>3.0x ULN, ALT: \>3.0x ULN, ALP: \>3.0x ULN, urea nitrogen: \>1.3x ULN, creatinine: \>1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin. |
| Percentage of Participants With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1 | 7 Days After Dose 2 | Chemistry parameters that were assessed included bilirubin, AST, ALT, ALP, urea nitrogen, creatinine. Abnormal parameters were determined by following criteria: bilirubin: \>1.5x ULN, AST: \>3.0x ULN, ALT: \>3.0x ULN, ALP: \>3.0x ULN, urea nitrogen: \>1.3x ULN, creatinine: \>1.3x ULN. Abnormal values reported for this outcome measure are for bilirubin. |
| Percentage of Participants With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1 | 1 Day After Dose 1 | Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: \<8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: \<8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: \<1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: \<250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: \>5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: \<25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: \>31; G4: requires dialysis. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1 | 7 Days After Dose 1 | Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: \<8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: \<8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: \<1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: \<250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: \>5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: \<25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: \>31; G4: requires dialysis. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Grade Shift in Hematology Parameters Before Dose 2: Phase 1 | Before Dose 2 | Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: \<8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: \<8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: \<1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: \<250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: \>5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: \<25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: \>31; G4: requires dialysis. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Grade Shift in Hematology Parameters 7 Days After Dose 2: Phase 1 | 7 Days After Dose 2 | Percentage of participants with grade shift in hematology parameters reported in this outcome measure. Grade(G)1: Mild, G2:Moderate, G3:Severe, G4:potentially life threatening. Hemoglobin(Female): G1: 11.0 - 12.0grams per deciliter(g/dL), G2: 9.5 - 10.9, G3: 8.0 - 9.4, G4: \<8.0. Hemoglobin(Male): G1: 12.5 - 13.5, G2: 10.5 - 12.4, G3: 8.5 - 10.4, G4: \<8.5. WBC decrease(cells/mm3):G1: 2,500 - 3,500, G2: 1,500 - 2,499, G3: 1,000 - 1,499, G4: \<1,000 Lymphocytes decrease(cells/mm3): G1: 750 - 1,000, G2: 500 - 749, G3: 250 - 499, G4: \<250. Eosinophils(cells/mm3):G1: 650 - 1500, G2: 1501 - 5000, G3: \>5000, G4:Hypereosinophilic. Platelets decreased(cells/mm3): G1: 125,000 - 140,000, G2: 100,000 - 124,000, G3: 25,000 - 99,000, G4: \<25,000. Urea Nitrogen (mg/dl): G1: 23-26; G2:27-31; G3: \>31; G4: requires dialysis. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Grade Shift in Chemistry Parameters 1 Day After Dose 1: Phase 1 | 1 Day After Dose 1 | Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(milligram per deciliter \[mg/dL\]): G1: 23 - 26, G2: 27 - 31, G3: \>31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: \> 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: \>10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: \>10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: \>1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: \>3.0 x ULN. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 1: Phase 1 | 7 Days After Dose 1 | Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: \>31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: \> 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: \>10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: \>10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: \>1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: \>3.0 x ULN. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Grade Shift in Chemistry Parameters Before Dose 2: Phase 1 | Before Dose 2 | Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: \>31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: \> 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: \>10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: \>10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: \>1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: \>3.0 x ULN. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Grade Shift in Chemistry Parameters 7 Days After Dose 2: Phase 1 | 7 Days After Dose 2 | Percentage of participants with grade shift in chemistry were reported in this outcome measure. G1: Mild, G2: Moderate, G3: Severe, G4: potentially life threatening. BUN(mg/dL): G1: 23 - 26, G2: 27 - 31, G3: \>31, G4: required dialysis. Creatinine(mg/dL): G1: 1.5 - 1.7, G2: 1.8 - 2.0, G3: 2.1 - 2.5, G4: \> 2.5 or required dialysis. Alkaline phosphate(increase by factor): G1: 1.1 - 2.0 x ULN G2: 2.1 - 3.0 x ULN G3: 3.1 -10 x ULN, G4: \>10 x ULN. Liver function tests(ALT, AST increase by factor): G1: 1.1 - 2.5 x ULN G2: 2.6 - 5.0 x ULN G3: 5.1 - 10 x ULN, G4: \>10 x ULN. Bilirubin(when accompanied by any increase in liver function test - increase by factor): G1: 1.1 - 1.25 x ULN G2: 1.26 - 1.5 x ULN G3: 1.51 - 1.75 x ULN, G4: \>1.75 x ULN. Bilirubin(when liver function test is normal - increase by factor): G1: 1.1 - 1.5 x ULN, G2: 1.6 - 2.0 x ULN, G3: 2.0 - 3.0 x ULN, G4: \>3.0 x ULN. Only parameters where grade shift was observed were reported. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2/3 | Within 7 Days after Dose 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2/3 | Within 7 Days after Dose 2 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2/3 | Within 7 Days after Dose 1 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2/3 | Within 7 Days after Dose 2 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). |
| Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3 | From Dose 1 to 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded from this analysis. |
| Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 2/3 | From Dose 1 to 6 Months After Dose 2 | An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded from this analysis. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 2 | Within 7 Days after Dose 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Phase 2 | Within 7 Days after Dose 2 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Phase 2 | Within 7 Days after Dose 1 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Phase 2 | Within 7 Days After Dose 2 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). |
| Percentage of Participants Reporting Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 | From Dose 1 to 7 Days After Dose 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 | From Dose 1 to 7 Days After Dose 2 | A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. |
| Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose | Within 7 Days After Booster Dose | Local reactions included redness, swelling and, pain at the injection site, recorded by participants or parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded. |
| Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose | Within 7 Days After Booster Dose | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded. |
| Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose | From First Booster Dose to 1 Month After Booster Dose | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded. |
| Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 6 Months After Booster Dose: BNT162b2 Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose | From First Booster Dose to 6 Months After Booster Dose | A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded. |
| Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA | Within 7 Days After Booster Dose 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded from this analysis. |
| Percentage of Participants With Local Reactions Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA | Within 7 Days after Booster Dose 2 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded from this analysis. |
| Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA | Within 7 Days After Booster Dose 1 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants excluded. |
| Percentage of Participants With Systemic Events Within 7 Days After Booster Dose 2: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA | Within 7 Days After Booster Dose 2 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants excluded. |
| Percentage of Participants Reporting Adverse Events From First Booster Dose to 1 Month After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA | From First Booster Dose to 1 Month After Second Booster Dose | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded. |
| Percentage of Participants Reporting Serious Adverse Events From First Booster Dose to 5 Months After Second Booster Dose: BNT162b2 Experienced Participants Assigned to Receive 2 Booster Doses of BNT162b2SA | From First Booster Dose to 5 Months After Second Booster Dose | An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA | Within 7 Days After Dose 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA | Within 7 Days After Dose 2 | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA | Within 7 Days After Dose 1 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2: BNT162b2 Naive Participants Who Were Enrolled to Receive BNT162b2SA | Within 7 Days After Dose 2 | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded. |
| Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA | From Dose 1 Through 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded. |
| Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: BNT162b2-Naïve Participants Who Were Enrolled to Receive BNT162b2SA | From Dose 1 to 6 Months After Dose 2 | A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded. |
| Percentage of Participants With Local Reactions Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) | Within 7 days After Booster Dose | Local reactions included redness, swelling and, pain at the injection site, recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\> 2.0 to 5.0 cm), moderate (\> 5.0 to 10.0 cm), severe (\>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalization for severe pain). HIV positive participants were excluded. |
| Percentage of Participants With Systemic Events Within 7 Days After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) | Within 7 days After Booster Dose | Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by participants or parents/legal guardians of participants using e-diary. Fever=temperature \>=38.0 deg C categorized as \>=38.0 to 38.4, \>38.4 to 38.9, \>38.9 to 40.0 and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalization). Vomiting: mild (1-2 times in 24 h), moderate (\>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalization for hypotensive shock). Diarrhea: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (\>=6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalization). HIV positive participants were excluded. |
| Percentage of Participants Reporting Adverse Events From Booster Dose to 1 Month After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) | From Booster Dose to 1 Months After Booster Dose | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. HIV positive participants were excluded. |
| Percentage of Participants Reporting Serious Adverse Events From Booster Dose to 6 Months After Booster Dose: BNT162b2-Experienced Participants Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) | From Booster Dose to 6 Months after Booster Dose | A SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. HIV positive participants were excluded. |
| COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3 | From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.247, Placebo - 6.003) | Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, without serological or virological evidence of prior SARS-CoV-2 infection were reported in this outcome measure. HIV positive participants were excluded from this analysis. |
| COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) | From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.214, Placebo - 2.222) | Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, without serological or virological evidence of prior SARS-CoV-2 infection (analysis for EUA) were reported in this outcome measure. |
| COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3 | From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.509, Placebo - 6.274) | Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, with or without serological or virological evidence of prior SARS-CoV-2 infection were reported in this outcome measure. |
| COVID-19 Incidence Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Participants With or Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) | From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.332, Placebo - 2.345) | Occurrences of first COVID-19 infection in participants followed up based on central laboratory or locally confirmed NAAT in participants, with or without serological or virological evidence (analysis for EUA) of prior SARS-CoV-2 infection were reported in this outcome measure. HIV positive participants were excluded from this analysis. |
| GMR Based on Geometric Mean Titer (N1a) - Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection (N1a) up to 1 Month After Dose 2: Phase 3 | 1 Month After Dose 2 | GMR based on geometric mean titer, comparison of 1 month after dose 2 between vaccine groups: BNT162b2-naive participants without evidence of infection up to 1 month after dose 2 were reported in this outcome measure. HIV positive participants excluded from this analysis. |
| Percentage Difference of Participants Achieving Seroresponse Comparison (N1b) of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 | 1 Month After Dose 2 | Seroresponse was defined as achieving a \>=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the lower limit of quantification (LLOQ), a post vaccination assay result \>=4 × LLOQ was considered a seroresponse. HIV positive participants excluded. |
| GMR of Neutralizing Titers (E1a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | GMR based on geometric mean titer, comparison of 1 month after booster dose to 1 month after dose 2 for BNT162b2-experienced participants were reported in this outcome measure. HIV positive participants excluded from this analysis. |
| Percentage Difference of Participants Achieving Seroresponse (E1b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | Percentage difference of participants achieving seroresponse - comparison of 1 month after booster dose to 1 month after Dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. Seroresponse was defined as achieving a \>=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result \>=4 × LLOQ was considered a seroresponse. HIV positive participants excluded. |
| GMR of Neutralizing Titers (E2a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | GMR of neutralizing titers (E2a) for comparison of 1 month after booster dose to 1 month after dose 2: BNT162b2-experienced participants in Phase 3 were reported in this outcome measure. HIV positive participants were excluded from this analysis. |
| Percentage Difference of Participants Achieving Seroresponse (E2b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | Percentage difference of participants achieving seroresponse - comparison of 1 month after booster dose to 1 month after Dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. Seroresponse was defined as achieving a \>=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result \>=4 × LLOQ was considered a seroresponse. HIV positive participants excluded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers: Phase 1 | 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2 | GMTs of severe acute respiratory syndrome coronavirus 2 neutralizing titers were reported in this outcome measure. SARS-CoV-2 neutralization assay - NT50 and SARS-CoV-2 neutralization assay - NT90 were evaluated and reported in this outcome measure. |
| Geometric Mean Concentrations (GMCs) of Severe Acute Respiratory Syndrome Coronavirus 2: S1-binding and RBD-binding IgG Level Assay: Phase 1 | 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2 | GMCs of severe acute respiratory syndrome coronavirus S1-binding and RBD-binding IgG level were reported in this outcome measure. |
| Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers: Phase 1 | 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2 | GMFR of SARS-CoV-2 neutralizing titers were reported in this outcome measure. HIV positive participants excluded. |
| Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 S1-binding and RBD-binding IgG Level Assay: Phase 1 | 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2 | GMFR of SARS-CoV-2 S1-binding and RBD-binding IgG level assay in Phase 1 were reported in this outcome measure. HIV positive participants were excluded from this analysis. |
| Percentage of Participants Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: Neutralizing Titers: Phase 1 | 7, 21 days after Dose 1; 7, 14 days and 1, 6 months after Dose 2 | Percentage of participants achieving a \>= 4-fold rise from before vaccination to after vaccination: neutralizing titers in Phase 1 were reported in this outcome measure. HIV positive participants were excluded from this analysis. |
| Percentage of Participants Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: S1-binding and RBD-binding IgG Level Assay: Phase 1 | From before vaccination to after vaccination | Percentage of participants achieving a \>= 4-fold rise from before vaccination to after vaccination: S1-binding and RBD-binding IgG level assay in Phase 1 were reported in this outcome measure. HIV positive participants were excluded from this analysis. |
| GMR Based on Reference Strain NT - Comparison of Participants 12 to 15 Years of Age to Participants 16 to 25 Years of Age- Participants Without Evidence of Infection up to 1 Month After Dose 2 - Dose 2 Evaluable Immunogenicity Population: Phase2/3 | 1 Month After Dose 2 | GMR based on reference strain NT, comparison of participants 12 to 15 years of age to participants 16 to 25 years of age of participants without evidence of infection up to 1 month after dose 2 in Phase2/3 were reported in this outcome measure. HIV positive participants were excluded from this analysis. |
| Incidence of Asymptomatic SARS-CoV-2 Infection Per 1000 Person Years Follow-up Without Serological or Virological Evidence (Up to Start of Asymptomatic Surveillance Period) of Past Infection: Phase 3 | From start of asymptomatic surveillance (Surveillance time [1000 person-years]: BNT162b2 - 0.383; Placebo - 0.200 | Incidence of asymptomatic SARS-CoV-2 infection per 1000 person years follow-up without serological or virological evidence (up to start of asymptomatic surveillance period) of past infection were reported in this outcome measure. |
| Incidence of Asymptomatic SARS-CoV-2 Infection Per 1000 Person Years Follow-up Without Serological or Virological Evidence of Past Infection Based on N-binding Antibody Seroconversion: Phase 3 | From Dose 2 to the end of the surveillance period ([1000 person-years]: BNT162b2 - 13.840, Placebo - 6.481) | Incidence of asymptomatic SARS-CoV-2 infection per 1000 person years follow-up without serological or virological evidence of past infection based on N-binding antibody seroconversion were reported in this outcome measure. |
| COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection 7 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 | From 7 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.330, Placebo - 2.343) | COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this outcome measure. |
| COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection 14 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 | From 14 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.983, Placebo - 1.993) | COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this outcome measure. |
| COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 | From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.213; Placebo - 2.220) | COVID-19 incidence per 1000 person years follow-up without the evidence of infection (analysis for EUA) were reported in this outcome measure. |
| COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 | From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.886; Placebo - 1.891) | COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this outcome measure. |
| Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 7 Days After Dose 2: Phase 3 | From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.522; Placebo - 6.404) | Severe COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this outcome measure. |
| Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 | From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.985; Placebo - 2.007) | Severe COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection (analysis for EUA) were reported in this outcome measure. |
| Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2: Phase 3 | From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.257; Placebo - 6.120) | Severe COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this outcome measure. |
| Severe COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 | From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.888; Placebo - 1.901) | Severe COVID-19 incidence per 1000 person years follow-up without the evidence of infection (analysis for EUA) were reported in this outcome measure. |
| COVID-19 Incidence Per 1000 Person-Years of With or Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 | From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.984; Placebo - 1.995) | COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection (analysis for EUA) were reported in this outcome measure. |
| COVID-19 Incidence Per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 | From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.887; Placebo - 1.893) | COVID-19 incidence per 1000 person years follow-up without the evidence of infection (analysis for EUA) were reported in this outcome measure. |
| Percentage Difference of Participants Achieving Seroresponse (Reference Strain) 1 Month After Second Dose in BNT162b2-Naive Participants: Phase 3 | 1 Month After Dose 2 | Seroresponse was defined as achieving a \>=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the lower limit of quantification (LLOQ), a post vaccination assay result \>=4 × LLOQ was considered a seroresponse. HIV positive participants were excluded from this analysis. |
| GMR Based on Geometric Mean Titer (Reference Strain) 1 Month After Second Dose in BNT162b2-Naive Participants: Phase 3 | 1 Month After Dose 2 | GMR based on GMT (Reference Strain) 1 month after second dose of BNT162b2SA and 1 month after the second dose of BNT162b2 in BNT162b2-naive participant were reported in this outcome measure. |
| GMR Based on Geometric Mean Titer of SA NT 1 Month After Second Dose of BNT162b2SA to 1 Month After the Second Dose (N2a) of BNT162b2 Naive Participants: Phase 3 | 1 month after the second dose | GMR based on geometric mean titer of SA NT 1 Month after second dose of BNT162b2SA to 1 Month after the second dose (N2a) of BNT162b2 naive participants of Phase 3 were reported in this outcome measure. |
| Percentage Difference of Participants Achieving Seroresponse (N2b) Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Participants Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 | 1 Month After Dose 2 | Seroresponse was defined as achieving a \>=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result \>=4 × LLOQ was considered a seroresponse. |
| GMR of Neutralizing Titers (E3a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | GMR of neutralizing titers (E3a) - comparison of 1 month after booster dose to 1 month after dose 2: BNT162b2-experienced participants of Phase 3 were reported in this outcome measure. |
| Percentage Difference of Participants Achieving Seroresponse (E3b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants That Received a Booster Dose of BNT162b2: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | Percentage difference of participants achieving seroresponse (E3b) - comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. |
| GMR of Neutralizing Titers (E4a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | GMR of neutralizing titers (E4a) - comparison of 1 month after booster dose to 1 month after dose 2: BNT162b2-experienced participants of Phase 3 were reported in this outcome measure. |
| Percentage Difference of Participants Achieving Seroresponse (E4b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Participants: Phase 3 | 1 Month After Booster Dose to 1 Month After Dose 2 | Percentage difference of participants achieving seroresponse (E4b) - comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. |
| Percentage Difference of Participants Achieving Seroresponse for SA Variant NT Comparison of 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Participants Assigned to Receive 2 Booster Doses of BNT162b2SA: Phase 3 | 1 Month after Second Booster Dose to 1 Month After Dose 2 of BNT162b2 | Percentage difference of participants achieving seroresponse for SA variant NT comparison of 1 Month after second booster dose to 1 Month after Dose 2 of BNT162b2 in participants assigned to receive 2 booster doses of BNT162b2SA of Phase 3 were reported in this outcome measure. |
| GMR of SA Variant NT 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Participants Assigned to Receive 2 Booster Doses of BNT1612b2SA: Phase 3 | 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 | GMR of SA variant NT 1 month after second booster dose to 1 month after dose 2 of BNT162b2 in participants assigned to receive 2 booster doses of BNT1612b2SA were reported in this outcome measure. |
| Percentage Difference of Participants Achieving Seroresponse for SA Variant NT: BNT162b2-Experienced Participants Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomized to Receive 1 Booster Dose: Phase 3 | 1 Month After Booster Dose | Percentage difference of participants achieving seroresponse for SA variant NT: BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. |
| GMR of SA Variant NT: BNT162b2-Experienced Participants Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomized to Receive 1 Booster Dose: Phase 3 | 1 Month After Booster Dose | GMR of SA Variant NT: BNT162b2-experienced participants without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this outcome measure. |
Countries
Argentina, Brazil, Germany, South Africa, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Pre-assignment details
A total of 46934 participants were randomized and assigned to the treatment. The study consisted of 2 parts. Phase 1: to identify preferred vaccine candidate and dose level of candidate vaccine; Phase 2/3: an expanded cohort and efficacy part.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized <=18 years | 1134 Participants |
| Age, Customized >=65 years | 9206 Participants |
| Age, Customized Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1177 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 544 Participants |
| Sex: Female, Male Male | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 12 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 35 | 0 / 39 | 23 / 22,012 | 61 / 22,010 | 38 / 20,357 | 0 / 1,129 | 0 / 1,131 | 1 / 1,014 | 47 / 23,403 | 0 / 381 | 0 / 15 | 0 / 71 | 0 / 242 | 0 / 30 | 0 / 306 | 0 / 318 | 0 / 330 | 0 / 79 | 0 / 76 | 2 / 180 | 0 / 180 |
| other Total, other adverse events | 23 / 24 | 23 / 24 | 23 / 24 | 12 / 12 | 18 / 24 | 22 / 24 | 23 / 24 | 7 / 35 | 24 / 39 | 3,848 / 22,012 | 9,587 / 22,010 | 5,446 / 20,357 | 760 / 1,129 | 1,091 / 1,131 | 238 / 1,014 | 3,326 / 23,403 | 27 / 381 | 1 / 15 | 1 / 71 | 23 / 242 | 26 / 30 | 263 / 306 | 270 / 318 | 309 / 330 | 47 / 79 | 64 / 76 | 166 / 180 | 100 / 180 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 12 | 0 / 24 | 1 / 24 | 1 / 24 | 0 / 35 | 0 / 39 | 293 / 22,012 | 430 / 22,010 | 354 / 20,357 | 2 / 1,129 | 13 / 1,131 | 13 / 1,014 | 69 / 23,403 | 1 / 381 | 0 / 15 | 0 / 71 | 0 / 242 | 1 / 30 | 2 / 306 | 2 / 318 | 4 / 330 | 1 / 79 | 0 / 76 | 1 / 180 | 0 / 180 |
Outcome results
None listed