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

NCT04634760

Last updated date
Study Location
SOUSEIKAI Sumida Hospital
Sumida-ku, Tokyo, 130-0004, Japan
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
SARS-CoV-2 Infection, COVID-19
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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