Influenza Vaccine AllergyNCT06446232
Influenza Vaccine Effectiveness in Among Young Children in Taiwan
An observational study of Influenza Vaccine Allergy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This project uses questionnaires to statistically analyze whether influenza vaccination is protective for young children. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Influenza Vaccine Allergy
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2023to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months to 18 years
- All sexes
- Child, Adult
Study population: Those who have performed a rapid influenza screening test, regardless of whether the result is negative or positive
Who may be able to join
- Clinical diagnosis of influenza by Flu A+B rapid antigen test
- Known vaccination status
Who cannot join
- Unknown vaccination status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
Official title: Influenza Vaccine Effectiveness in Inpatient and Outpatient Settings Among Young Children in Taiwan
This project uses questionnaires to statistically analyze whether influenza vaccination is protective for young children.
Read the detailed description
This plan is expected to admit 350 children who are admitted to the emergency department or hospitalized due to influenza and are aged from 6 months (inclusive) to under 18 years old. Vaccine status, statistical analysis of whether the flu vaccine is protective.
- Conditions
- Influenza Vaccine Allergy
- Keywords
- Influenza Vaccine
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires
This project uses questionnaires to statistically analyze whether the flu vaccine is protective for young children. Researchers collect flu rapid test results and invite subjects to write questionnaires. Data collectors administered a standardised questionnaire that included information on demographics, medical history (including flu vaccination status and self-reported prior flu infection).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Vaccine AllergyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446232
- Sponsor's protocol ID
- 202304120RINC
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccine Effectiveness in Inpatient and Outpatient Settings Among Young Children in Taiwan
- ClinicalTrials.gov ID
- NCT06446232
- Acronym / sponsor ID
- 202304120RINC
- Conditions
- Influenza Vaccine Allergy
- Keywords
- Influenza Vaccine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 6 Jun 2024 (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.
This project uses questionnaires to statistically analyze whether influenza vaccination is protective for young children.
Detailed description
This plan is expected to admit 350 children who are admitted to the emergency department or hospitalized due to influenza and are aged from 6 months (inclusive) to under 18 years old. Vaccine status, statistical analysis of whether the flu vaccine is protective.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Those who have performed a rapid influenza screening test, regardless of whether the result is negative or positive
Key inclusion criteria (2 listed)
- Clinical diagnosis of influenza by Flu A+B rapid antigen test
- Known vaccination status
Key exclusion criteria (1 listed)
- Unknown vaccination status
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
Questionnaires
Time frame: 12 months
This project uses questionnaires to statistically analyze whether the flu vaccine is protective for young children. Researchers collect flu rapid test results and invite subjects to write questionnaires. Data collectors administered a standardised questionnaire that included information on demographics, medical history (including flu vaccination status and self-reported prior flu infection).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine Allergy, run by National Taiwan University Hospital at 1 site in Taiwan.
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: looking for participants now, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Jen Liau (02-23123456 ext. 271729, u8809032@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaires (time frame: 12 months). 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 6 Jun 2024.