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NCT03328325 · ClinicalTrials.gov registry record · Phase 4
Age and Response to Flu Vaccines
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 152
- Enrollment target
NCT03328325 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 152 participants.
The verdict
NCT03328325, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 152 participants
- Enrollment target
Study Summary
The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.
Interventions
- BIOLOGICAL Influenza Virus Quadrivalent Inactivated Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2017-12-14 |
| Est. Completion | 2020-04-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03328325
The ClinicalTrials.gov registry entry for NCT03328325 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Quadrivalent Inactivated Vaccine is the first listed.
NCT03328325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03328325 about?
NCT03328325 is a clinical study titled "Age and Response to Flu Vaccines". The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza va...
What is the current status of trial NCT03328325?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 152 participants. The study started on 2017-12-14. Estimated completion is 2020-04-20.
What interventions are being tested in trial NCT03328325?
The interventions under investigation include: Influenza Virus Quadrivalent Inactivated Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03328325?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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