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

NCT ID: NCT04588480

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2021-11-25

Brief Summary

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:

• As 2 doses, separated by 21 days
• At a single dose level
• In adults 20 to 85 years of age

Detailed Description

From protocol amendment 3, this study is transitioned from a clinical trial to a postmarketing study (Phase 4) according to the Japanese regulation, because BNT162b2 was approved by the Ministry of Health, Labour and Welfare on 14 February 2021.

Conditions

SARS-CoV-2 Infection; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

BNT162b2

BNT162b2 (intramuscular injection)

Group Type: EXPERIMENTAL

BNT162b2

Intervention Type: BIOLOGICAL

BNT162b2 (intramuscular injection)

Placebo

Placebo (intramuscular injection)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo (intramuscular injection)

Interventions

BNT162b2

BNT162b2 (intramuscular injection)

Intervention Type: BIOLOGICAL

Placebo

Placebo (intramuscular injection)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

BioNTech SE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

SOUSEIKAI Sumida Hospital

Sumida-ku, Tokyo, Japan

SOUSEIKAI PS Clinic

Fukuoka, , Japan

Countries

Japan

References

Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Tureci Ӧ, Sahin U, Dormitzer PR, Gruber WC, Lockhart S. A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults. Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.

Reference Type: DERIVED

PMID: 34907170 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4591005

To obtain contact information for a study center near you, click here.

Other Identifiers

C4591005

Identifier Type: -

Identifier Source: org_study_id