Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination

NCT ID: NCT04941144

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8538 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-22

Study Completion Date

2023-04-28

Brief Summary

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This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine.

The number of visits to the clinic will depend on the clinic's standard practice.

Detailed Description

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Conditions

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Coronavirus Disease (COVID-19)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 Vaccine Intramuscular Injection 0.5 milliliters (mL)

COVID-19 vaccine intramuscular injection, 2 doses of 0.5 mL per dose administered intramuscularly at an interval of 4 weeks.

COVID-19 Vaccine

Intervention Type BIOLOGICAL

COVID-19 Vaccine Intramuscular Injection

Interventions

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COVID-19 Vaccine

COVID-19 Vaccine Intramuscular Injection

Intervention Type BIOLOGICAL

Other Intervention Names

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COVID-19 Vaccine Moderna Intramuscular Injection Spikevax Intramuscular Injection

Eligibility Criteria

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Inclusion Criteria

Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study.

Exclusion Criteria

None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Moderna selected site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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jRCT2031210168

Identifier Type: REGISTRY

Identifier Source: secondary_id

mRNA-1273-P918

Identifier Type: -

Identifier Source: org_study_id

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