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NCT00570037 · ClinicalTrials.gov registry record · NA
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 544
- Enrollment target
NCT00570037 is a NA study that has completed, run by Duke University. The registered enrollment target is 544 participants.
The verdict
NCT00570037, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 544 participants
- Enrollment target
Study Summary
Influenza causes epidemics of respiratory infection in young children each winter. Young children, particularly those under 6 months of age are most vulnerable to suffering from complications secondary to influenza infection. Consequently, influenza vaccine has been recommended for children 6-59 months of age. Influenza vaccine is not approved for use in children under 6 month of age who are at highest risk. Therefore, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices has recommended vaccination of household contacts of children under 6 month of age - a cocooning strategy. The current study is a hospital-based study to assess the effectiveness of a program to vaccinate birth mothers and household contacts of newborns with influenza vaccine. We propose to study both birth mothers and household contacts of newborns delivered at Durham Regional Hospital and Duke University Medical Center, birthing hospitals serving Durham and surrounding counties in central North Carolina. We will implement several strategies to increase vaccine coverage rates at Durham Regional Hospital utilizing Duke University Hospital as a comparison setting. Strategies will include: standing vaccine orders for birth mothers, vaccine reminders for household contacts, and a hospital based influenza vaccine clinic to increase vaccine accessibility for household contacts. Vaccine coverage rates will be assessed utilizing a survey method (maternal interview at the birthing hospital and a follow-up telephone contact 6-8 weeks later). We hypothesize that influenza vaccine coverage rates for new mothers and household contacts of newborns delivered at the intervention hospital will be higher when compared to coverage rates in the comparison hospital. Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine will also be assessed.
Interventions
- BIOLOGICAL Trivalent inactivated influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00570037
The ClinicalTrials.gov registry entry for NCT00570037 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 544 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trivalent inactivated influenza vaccine is the first listed.
NCT00570037 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00570037 about?
NCT00570037 is a clinical study titled "Feasibility of Cocooning Immunization Strategy With Influenza Vaccine". Influenza causes epidemics of respiratory infection in young children each winter. Young children, particularly those under 6 months of age are most vulnerable to suffering from complications secondary to influenza infection. Consequently, influenza vaccine has been recommended for children 6-59 mon...
What is the current status of trial NCT00570037?
This trial is currently completed. It is a NA study. The enrollment target is 544 participants. The study started on 2007-10. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00570037?
The interventions under investigation include: Trivalent inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00570037?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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