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| Tracking Information | |||||
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| First Received Date ICMJE | December 7, 2007 | ||||
| Last Updated Date | May 4, 2008 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Influenza vaccine coverage rates for new mothers and household contacts of newborns [ Time Frame: Pregnancy through 6 weeks postpartum ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00570037 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Feasibility of Cocooning Immunization Strategy With Influenza Vaccine | ||||
| Official Title ICMJE | Prevention of Influenza in Infants by Immunization of Their Contacts in the Household | ||||
| Brief 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 control 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 and self report of the birth mothers. 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 control hospital. Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine will also be assessed. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Parallel Assignment | ||||
| Condition ICMJE | Influenza | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00570037 | ||||
| Responsible Party | Emmanuel Walter MD, MPH (Principal Investigator), Duke University Health System | ||||
| Study ID Numbers ICMJE | 9436-07-2R0ER, 1 U01 IP000074-01 | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | Centers for Disease Control and Prevention | ||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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