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

General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During the Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04941144

Enrollment

8538

Registered

2021-06-28

Start date

2021-12-22

Completion date

2023-04-28

Last updated

2023-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease (COVID-19)

Brief summary

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.

Interventions

BIOLOGICALCOVID-19 Vaccine

COVID-19 Vaccine Intramuscular Injection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants with Serious Adverse Events (SAE)	11 months (From 28 days to 12 months after the second vaccination)	An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.

Secondary

Measure	Time frame	Description
Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study	11 months (From 28 days to 12 months after the second vaccination)	—
Number of Participants who Developed COVID-19 during the Study	11 months (From 28 days to 12 months after the second vaccination)	—
Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator	11 months (From 28 days to 12 months after the second vaccination)	Number of participants who have severe COVID-19 infection during the study evaluated by investigator will be reported. Investigator will evaluate the severity of COVID-19 infection with COVID-19 information entered in the case report form in reference to Guidance for Clinical Practice of Novel Coronavirus Infection (COVID-19).

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026