Skip to main content
OpenTrials
Completed

NCT Number: NCT04941144

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronavirus Disease (COVID-19) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Moderna selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 vaccine

Biological

COVID-19 Vaccine Intramuscular Injection

Other names: COVID-19 Vaccine Moderna Intramuscular Injection, Spikevax Intramuscular Injection

Primary outcomes

  1. Percentage of Participants with Serious Adverse Events (SAE)

    Time frame: 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 outcomes

  1. Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study

    Time frame: 11 months (From 28 days to 12 months after the second vaccination)

  2. Number of Participants who Developed COVID-19 during the Study

    Time frame: 11 months (From 28 days to 12 months after the second vaccination)

  3. Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator

    Time frame: 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)".

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.