An interventional study of Trivalent inactivated influenza vaccine in Influenza, sponsored by Duke University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 544 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders
Biological: Trivalent inactivated influenza vaccine
Comparison Hospital - Receipt of vaccine through routine clinical care
Intramuscular injection, 0.5 mL or 0.25 mL depending on age of vaccine recipient, one or two doses administered a month apart depending on age and prior influenza vaccination history of recipient
Also known as: Fluzone
Influenza Vaccine Coverage (Percent) for New Mothers of Newborns
The percent of new mothers delivering at the hospital who reported receiving an influenza vaccine during their pregnancy, in the hospital after delivery, or during the 6 to 8 week postpartum period
Time frame: Pregnancy period through 6 to 8 weeks postpartum
Influenza Vaccine Coverage (Percent) for New Fathers of Newborns
The percent of new fathers who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby
Time frame: Pregnancy period through 6 to 8 weeks postpartum
Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns
The percent of all household contacts of newborns who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby
Time frame: Pregnancy period through 6 to 8 weeks postpartum
October 2007 through February 2008 Post partum units of two Durham, North Carolina hospitals
| Milestone | Hospital With Immunization Program | Hospital With No Immunization Program |
|---|---|---|
| Started | 238 | 306 |
| Completed | 194 | 237 |
| Not completed | 44 | 69 |
| Withdrew: Could not reach for 6-8 week contact | 44 | 69 |
The percent of new mothers delivering at the hospital who reported receiving an influenza vaccine during their pregnancy, in the hospital after delivery, or during the 6 to 8 week postpartum period
| Percentage of Participants | Hospital With Immunization Program | Hospital With No Immunization Program |
|---|---|---|
| Influenza Vaccine Coverage (Percent) for New Mothers of Newborns | 70 | 64 |
The percent of new fathers who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby
| Percentage of Fathers of Newborns | Hospital With Immunization Program | Hospital With No Immunization Program |
|---|---|---|
| Influenza Vaccine Coverage (Percent) for New Fathers of Newborns | 53 | 26 |
The percent of all household contacts of newborns who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby
| Percentage of All Household Contacts | Hospital With Immunization Program | Hospital With No Immunization Program |
|---|---|---|
| Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns | 55 | 39 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hospital With Immunization Program | — | 0/238 (0%) | — |
| Hospital With No Immunization Program | — | 0/306 (0%) | — |
| Age, Categorical(Participants) | Hospital With Immunization Program | Hospital With No Immunization Program | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 238 | 306 | 544 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Hospital With Immunization Program | Hospital With No Immunization Program | Total |
|---|---|---|---|
| Female | 238 | 306 | 544 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Hospital With Immunization Program | Hospital With No Immunization Program | Total |
|---|---|---|---|
| United States | 238 | 306 | 544 |
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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