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NCT01164553 · ClinicalTrials.gov registry record · Phase 1
Comparison of Flu Vaccine Doses in Children
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 243
- Enrollment target
- 7
- Study locations
NCT01164553: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01164553 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 243 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01164553, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 243 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasing side effects. Investigators will evaluate the body's response to the vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine, and those ages 12-35 months, who have been previously vaccinated, will participate in the study for about 7 months. Vaccine naïve study participants will receive two doses of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Study procedures include physical examination, memory aids, blood sampling and a follow-up phone call about 6 months after the last vaccine dose.
Conditions Studied
Interventions
- BIOLOGICAL Trivalent Inactivated Influenza Vaccine
Study Locations (7)
Georgia
- Emory Children's Center - Pediatric Infectious Diseases - Atlanta
- Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases - Atlanta
Iowa
- University of Iowa - Infectious Disease Clinic - Iowa City
Maryland
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore - Baltimore
Missouri
- Saint Louis University - Center for Vaccine Development - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Infectious Diseases - Cincinnati
Tennessee
- Vanderbilt University - Pediatric - Infectious Diseases - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT01164553 record still lists
NCT01164553 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Trivalent Inactivated Influenza Vaccine is the first listed.
NCT01164553 lists 7 locations in 6 states (Georgia, Iowa, Maryland).
Frequently Asked Questions
What is clinical trial NCT01164553 about?
NCT01164553 is a clinical study titled "Comparison of Flu Vaccine Doses in Children". The purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasing side effects. Investigators will evaluate the body's response to the vaccine. Male and female part...
What is the current status of trial NCT01164553?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 243 participants. The study started on 2010-10. Estimated completion is 2012-10.
What conditions does trial NCT01164553 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01164553?
The interventions under investigation include: Trivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01164553?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01164553 being conducted?
This trial has 7 study locations across Georgia, Iowa, Maryland, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01164553's enrollment target sits among peer trials
243 75th of 156 higher than 82 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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