Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01IP000074-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunization Program | Active Comparator | Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders |
|
| No Immunization Program | No Intervention | Comparison Hospital - Receipt of vaccine through routine clinical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent inactivated influenza vaccine | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Pregnancy period through 6 to 8 weeks postpartum |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel B Walter, MD, MPH | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham Regional Hospital | Durham | North Carolina | 27704 | United States | ||
| Duke University Hospital |
Not provided
October 2007 through February 2008 Post partum units of two Durham, North Carolina hospitals
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hospital With Immunization Program | |
| FG001 | Hospital With No Immunization Program |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hospital With Immunization Program | |
| BG001 | Hospital With No Immunization Program | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | Percentage of Participants | Pregnancy period through 6 to 8 weeks postpartum |
|
|
Not provided
Only serious adverse events collected and reported
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hospital With Immunization Program |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel Walter MD, Principal Investigator | Duke University Medical Center | 919-620-5374 | walte002@mc.duke.edu |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Durham |
| North Carolina |
| 27710 |
| United States |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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 | Posted | Number | Percentage of Fathers of Newborns | Pregnancy period through 6 to 8 weeks postpartum |
|
|
|
| Primary | 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 | Posted | Number | Percentage of All Household Contacts | Pregnancy period through 6 to 8 weeks postpartum |
|
|
|
| 0 |
| 238 |
| 0 |
| 0 |
| EG001 | Hospital With No Immunization Program | 0 | 306 | 0 | 0 |
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |