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NCT03673345 · ClinicalTrials.gov registry record · Phase 4
Development of Childhood Anti-Influenza Immunity
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 125
- Enrollment target
NCT03673345 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 125 participants.
The verdict
NCT03673345, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 125 participants
- Enrollment target
Study Summary
This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children between 6-12 months of age, 60 children greater than 12 months of age and born after 2009, 30 children with a birth date between 2006 and 2009, and 30 children with a birth date between 2003 and 2006. 80 children presenting with natural influenza infection prior to receipt of influenza vaccination also will be divided into 4 age cohorts: 20 children between 3-12 months of age, 20 children greater than 12 months of age with a birth date after 2009, 20 children with a birth date between 2006 and 2009, and 20 children with a birth date between 2003 and 2006. Influenza vaccines will be administered using age-appropriate guidelines in all years of the study: Fluzone 0.25 mL administered intramuscularly to children between 6 and 35 months of age and 0.5 mL to children 36 months of age and older. Subjects will be seen at one domestic site and their participation duration is 2 influenza seasons plus 1 optional season. The primary hypothesis being tested in this study is that there will be differences in the specificity, magnitude and functionality of CD4 T cell and B cell reactivity in a cohort of children depending on early childhood exposures. The primary objective of this study is to evaluate the relationship between influenza virus exposure, infection and vaccine history, and CD4 T cell reactivity in a cohort of children with well documented influenza exposures.
Interventions
- BIOLOGICAL Influenza Virus Quadrivalent Inactivated Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2020-12-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03673345
The ClinicalTrials.gov registry entry for NCT03673345 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 125 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.
NCT03673345 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03673345 about?
NCT03673345 is a clinical study titled "Development of Childhood Anti-Influenza Immunity". This study is a prospective surveillance of the immune response to seasonal vaccination in healthy children. The study will enroll a total of approximately 220 subjects. 140 children will be vaccinated with inactivated influenza vaccine (IIV) and will be divided into 4 age cohorts: 20 children betwe...
What is the current status of trial NCT03673345?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 125 participants. The study started on 2018-09-25. Estimated completion is 2020-12-22.
What interventions are being tested in trial NCT03673345?
The interventions under investigation include: Influenza Virus Quadrivalent Inactivated Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03673345?
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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