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Sponsors and Collaborators: |
Duke University Centers for Disease Control and Prevention |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00570037 |
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.
Condition | Intervention |
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Influenza |
Biological: Trivalent inactivated influenza vaccine Other: Control |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Prevention of Influenza in Infants by Immunization of Their Contacts in the Household |
Estimated Enrollment: | 600 |
Study Start Date: | October 2007 |
Study Completion Date: | April 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
Intervention Hospital
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Biological: Trivalent inactivated influenza vaccine
Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders
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2: No Intervention
Control Hospital
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Other: Control
Control, usual care
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Durham Regional Hospital | |
Durham, North Carolina, United States, 27704 | |
Duke University Hospital | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Emmanuel B Walter, MD, MPH | Duke University Health System |
Responsible Party: | Duke University Health System ( Emmanuel Walter MD, MPH (Principal Investigator) ) |
Study ID Numbers: | 9436-07-2R0ER, 1 U01 IP000074-01 |
Study First Received: | December 7, 2007 |
Last Updated: | May 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00570037 |
Health Authority: | United States: Institutional Review Board |
Influenza Vaccine Children |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |