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NCT00455169 · ClinicalTrials.gov registry record
Influenza Vaccine in Premature Infants
A clinical trial, sponsored by University of Rochester.
- Completed
- Registry status
- 66
- Enrollment target
NCT00455169: Completed study, sponsored by University of Rochester.
NCT00455169 is a clinical trial that has completed, run by University of Rochester. The registered enrollment target is 66 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00455169 has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- 66 participants
- Enrollment target
Study Summary
Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates about five times higher than healthy children. Influenza vaccine does not protect young children against influenza as well as it does healthy adults. A small study that measured antibodies (proteins that protect against infection) to influenza suggested that premature infants get even less protection from influenza vaccine than full-term infants. More information about influenza vaccine in premature infants is needed. The overall goals of this project are to collect information about the how well the influenza vaccine induces antibody production, and to develop the collaborative network of centers necessary for a larger trial of influenza vaccine in premature infants. Objective and Hypotheses. The objective of this study is to measure the amount of protective antibody produced by influenza vaccine in premature (less than 30 weeks' \[about 7 months\] gestation at birth), extremely-low-birth-weight (1000 grams \[2¼ pounds\] or less at birth) infants. Influenza vaccine needs to be given yearly. We will assess premature infants during their first series of influenza vaccines. We hypothesize that the levels of antibody will be lower in premature infants receiving their first series of influenza vaccine than in full-term infants. Design. We will measure the immune response in premature and full term infants. During the 2007-2008 influenza season, a total of 92 subjects, divided among 2 groups (premature infants 6-17 months old receiving their first influenza vaccine series and full-term infants 6-17 months old receiving their first influenza vaccine series) will be recruited at a consortium of five centers (the University of Rochester, the University of Texas Southwestern Medical Center, Wake Forest University, the University of Miami and the St
Interventions
- BIOLOGICAL Trivalent Inactivated Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-05 |
What the finished NCT00455169 record still lists
NCT00455169 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Trivalent Inactivated Influenza Vaccine is the first listed.
NCT00455169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00455169 about?
NCT00455169 is a clinical study titled "Influenza Vaccine in Premature Infants". Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates about five times higher than healthy children. Influenza vaccine does n...
What is the current status of trial NCT00455169?
This trial is currently completed. The enrollment target is 66 participants. The study started on 2007-10. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00455169?
The interventions under investigation include: Trivalent Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00455169?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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