臨床研究等提出・公開システム

A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Complete

Oct. 21, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

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.

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.
- 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.

Both

COVID-19

BNT162b2 (intramuscular injection), Placebo (intramuscular injection)

* Local reactions (Pain at the injection site, redness, and swelling as self-reported on electronic diaries.) for 7 days after dose 1 and dose 2
* Systemic events (Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.) for 7 days after dose 1 and dose 2
* AEs from Dose 1 to 1 month after the last dose
* SAEs from Dose 1 to 12 months after the last dose
* SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs at 1 month after dose 2
* GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to 1 month after Dose 2
* SARS-CoV-2 S1-binding IgG levels, expressed as GMCs at 1 month after Dose 2
* GMFR in SARS-CoV-2 S1-binding IgG levels from before vaccination to 1 month after Dose
In addition, in a subset participants, the percentage of participants with:
* Abnormal hematology and chemistry laboratory values 1 and 7 days after Dose 1; and 7 days after Dose 2
* Grading shifts in hematology and chemistry laboratory assessments between baseline and 1 and 7 days after Dose 1; and before Dose 2 and 7 days after Dose 2

* SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs, through 1 year after dose 2
* GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, through 1 year after dose 2 from baseline
* SARS-CoV-2 S1-binding IgG levels, expressed as GMCs, through 1 year after dose 2
* GMFR in SARS-CoV-2 S1-binding IgG levels from before vaccination to each subsequent time point, through 1 year after dose 2 from baseline
* GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS
CoV 2 S1-binding IgG levels, through 1 year after dose 2

+81-92-283-7701

Sept. 11, 2020

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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