Prevention of Infectious Disease Caused by SARS-CoV-2NCT05084755
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
An observational study of Prevention of Infectious Disease Caused by SARS-CoV-2, run by AstraZeneca at 3 sites in Japan.
Trial summary
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prevention of Infectious Disease Caused by SARS-CoV-2
- How many people
- 4 participants
- Where
- 3 sitesJapan
- Study dates
- 11 Nov 2021to 16 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects with underlying disease at high-risk for worsening COVID-19
Who may be able to join
- The subjects with underlying disease at high-risk for worsening COVID-19.
- The adults (in the case of a minor aged less than 20 years, the parent or the legal guardian) who are able to enter their symptoms in the health observation diary and who have been fully informed and have given written consent to the use of the needed information to be part of the observational study.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: VAXZEVRIA Intramuscular Injection Specific Use Result Study for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.
The present study aims to collect information on adverse drug reactions or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine.
Read the detailed description
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.
The present study aims to collect information on adverse drug reactions (local/systemic reactions), adverse events (including Shock/ Anaphylaxis, Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions ,Vaccine-associated enhanced disease(VAED) including Vaccine-associated enhanced respiratory disease(VAERD) and Thrombosis) or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT).
Adverse events that the investigator could not deny the causal relationship with VAXZEVRIA will be treated as adverse drug reactions. Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT).
Measured: from the first vaccination date to 28 days after the second vaccination date
Number of local/systemic reactions and its incidence (%) will be calculated for each reaction and also by grade. Ad hoc analysis might be performed as necessary.
Local/systemic reactions recorded in health observation diary by subjects and entered by the investigator in eCRF will be treated as specific adverse events and number of local/systemic reactions and its incidence (%) will be calculated for each reaction and also by grade. Ad hoc analysis might be performed as necessary.
Measured: each vaccination day (Day 1) to Day 8
Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case.
Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case based on the severity classification reference of "A guide for front-line healthcare workers (MHLW, 2020)". Ad hoc analysis might be performed as necessary.
Measured: from the first vaccination date to 28 days after the second vaccination date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start11 Nov 2021
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Why it stopped: In Japan, the government purchases VAXZEVRIA and distributes it to medical institutions. Based on Japan VAXZEVRIA vaccination plan, the last vaccination day was Sep. 30, 2022. So it was difficult to continue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Infectious Disease Caused by SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084755
- Sponsor's protocol ID
- D8111C00006
- Status last verified
- Feb 2024
- First submitted
- 19 Oct 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAXZEVRIA Intramuscular Injection Specific Use Result Study for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
- ClinicalTrials.gov ID
- NCT05084755
- Acronym / sponsor ID
- D8111C00006
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: In Japan, the government purchases VAXZEVRIA and distributes it to medical institutions. Based on Japan VAXZEVRIA vaccination plan, the last vaccination day was Sep. 30, 2022. So it was difficult to continue this study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.
The present study aims to collect information on adverse drug reactions or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine.
Detailed description
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.
The present study aims to collect information on adverse drug reactions (local/systemic reactions), adverse events (including Shock/ Anaphylaxis, Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions ,Vaccine-associated enhanced disease(VAED) including Vaccine-associated enhanced respiratory disease(VAERD) and Thrombosis) or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects with underlying disease at high-risk for worsening COVID-19
Key inclusion criteria (2 listed)
- The subjects with underlying disease at high-risk for worsening COVID-19.
- The adults (in the case of a minor aged less than 20 years, the parent or the legal guardian) who are able to enter their symptoms in the health observation diary and who have been fully informed and have given written consent to the use of the needed information to be part of the observational study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT).
Time frame: from the first vaccination date to 28 days after the second vaccination date
Adverse events that the investigator could not deny the causal relationship with VAXZEVRIA will be treated as adverse drug reactions. Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT).
Number of local/systemic reactions and its incidence (%) will be calculated for each reaction and also by grade. Ad hoc analysis might be performed as necessary.
Time frame: each vaccination day (Day 1) to Day 8
Local/systemic reactions recorded in health observation diary by subjects and entered by the investigator in eCRF will be treated as specific adverse events and number of local/systemic reactions and its incidence (%) will be calculated for each reaction and also by grade. Ad hoc analysis might be performed as necessary.
Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case.
Time frame: from the first vaccination date to 28 days after the second vaccination date
Number of the subjects considered to be severe case of COVID-19 and its incidence (%) will be calculated. The subject who required a hospitalization in intensive care unit or use of respirator will be defined as a severe case based on the severity classification reference of "A guide for front-line healthcare workers (MHLW, 2020)". Ad hoc analysis might be performed as necessary.
Results and safety
The study was stopped early (reason given: In Japan, the government purchases VAXZEVRIA and distributes it to medical institutions. Based on Japan VAXZEVRIA vaccination plan, the last vaccination day was Sep. 30, 2022. So it was difficult to continue this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Prevention of Infectious Disease Caused by SARS-CoV-2
Not yet recruitingPhase 2
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Covid19 Pneumonia
RecruitingPhase 1/2
A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
COVID-19, SARS-CoV-2 Infection
Not yet recruiting
Noseguard for Prevention of Respiratory Infections in Real-World Use
Respiratory Infection Virus, COVID-19
Active, not recruitingPhase 2/3
Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis
Pulmonary Fibrosis, COVID-19 Pneumonia
RecruitingObservational study
The Incidence of Pulmonary, Cardiovascular and Renal System Non-communicable Complications Associated With the Post-acute Phase of the Infection by Covid-19
Pulmonary Complications, Cardiovascular Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Infectious Disease Caused by SARS-CoV-2, run by AstraZeneca at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: In Japan, the government purchases VAXZEVRIA and distributes it to medical institutions. Based on Japan VAXZEVRIA vaccination plan, the last vaccination day was Sep. 30, 2022. So it was difficult to continue this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse drug reactions, its incidence (%) (number of adverse drug reaction/number of eligible safety analysis population) will be calculated by preferred term (PT). (time frame: from the first vaccination date to 28 days after the second vaccination date). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.