COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04588480

Pfizer

ClinicalTrials.gov_Inquiries@pfizer.com

2020-10-19

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - japanese male or female participants between the ages of 20 and 85 years, inclusive, at randomization. - 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. - capable of giving personal signed informed consent.

- 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 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 confirmed diagnosis of covid-19. - 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. - 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. - 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. - subset only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ grade 1 abnormality. - 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.

2

BioNTech SE

20

85

Japan

Healthy volunteers

N/A

160

Geometric Mean Fold Rises (GMFRs) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After Dose 2;Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 2;Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category;Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 1 by Age Category;Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 2 by Age Category;Percentage of Participants With Adverse Events (AEs) From Dose 1 up to 1 Month After Dose 2;Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1;Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2;Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 up to 12 Months After Dose 2;Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category;Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category;Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category;Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1;Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2

None

Phase 4

[{"arm_notes": "2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]