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NCT01246999 · ClinicalTrials.gov registry record · Phase 4
Effect of Age and Prior Immunity to Response to Seasonal Influenza Vaccines in Children
A Phase 4 study of Influenza, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
- 2
- Study locations
NCT01246999: Completed Phase 4 study of Influenza, sponsored by University of Rochester.
NCT01246999 is a Phase 4 study of Influenza that has completed, run by University of Rochester. The registered enrollment target is 34 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01246999, a Phase 4 study of Influenza, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
- 2
- Study locations
Study Summary
A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed by TIV separated by 28 days. Children with a laboratory documented history of prior H1N1 infection will be excluded.
Primary Outcome
Nasal washes were collected on days 2, 4 and 7 after vaccination. Nasal swab specimens were tested for the presence of vaccine viruses by quantitative viral culture in MDCK cells at 33º C and by real-time quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) amplification. The limit of detection of vaccine viruses was 10\^0.6 tissue culture infectious doses (50%)/ml for virus culture and 10\^0.4 tissue culture infectious doses (50%)/ml for qRT-PCR.
Conditions Studied
Interventions
- BIOLOGICAL Trivalent Influenza Vaccine
- BIOLOGICAL Live attenuated Influenza vaccine
- BIOLOGICAL TIV followed by LAIV
- BIOLOGICAL LAIV followed by TIV
Study Locations (2)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
New York
- Vaccine Research Unit Room 3-5000 - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
What the finished NCT01246999 record still lists
NCT01246999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 4 interventions - of which Trivalent Influenza Vaccine is the first listed.
NCT01246999 reports a single indexed study location in New Hampshire, New York.
Frequently Asked Questions
What is clinical trial NCT01246999 about?
NCT01246999 is a clinical study titled "Effect of Age and Prior Immunity to Response to Seasonal Influenza Vaccines in Children". A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed by TIV separated by 28...
What is the current status of trial NCT01246999?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2010-10. Estimated completion is 2013-06.
What conditions does trial NCT01246999 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01246999?
The interventions under investigation include: Trivalent Influenza Vaccine (BIOLOGICAL), Live attenuated Influenza vaccine (BIOLOGICAL), TIV followed by LAIV (BIOLOGICAL), LAIV followed by TIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT01246999?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01246999 being conducted?
This trial has 2 study locations across New Hampshire, New York. 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 NCT01246999's enrollment target sits among peer trials
34 136th of 156 higher than 20 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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