Influenza
Conditions
Keywords
Influenza, Vaccine, Children
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 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
BIOLOGICALTrivalent inactivated influenza vaccine
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
Sponsors
Centers for Disease Control and Prevention
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Mother of a newborn delivered at either Durham Regional Hospital or Duke University Hospital between October 2007 and February 2008
Exclusion criteria
* Fetal demise or stillbirth * Maternal rights relinquished * Language barrier
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influenza Vaccine Coverage (Percent) for New Mothers of Newborns | Pregnancy period through 6 to 8 weeks postpartum | 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 |
| Influenza Vaccine Coverage (Percent) for New Fathers of Newborns | Pregnancy period through 6 to 8 weeks postpartum | 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 |
| Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns | Pregnancy period through 6 to 8 weeks postpartum | 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 |
Countries
United States
Participant flow
Recruitment details
October 2007 through February 2008 Post partum units of two Durham, North Carolina hospitals
Participants by arm
| Arm | Count |
|---|---|
| Hospital With Immunization Program | 238 |
| Hospital With No Immunization Program | 306 |
| Total | 544 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Could not reach for 6-8 week contact | 44 | 69 |
Baseline characteristics
| Characteristic | Hospital With Immunization Program | Hospital With No Immunization Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 238 Participants | 306 Participants | 544 Participants |
| Region of Enrollment United States | 238 participants | 306 participants | 544 participants |
| Sex: Female, Male Female | 238 Participants | 306 Participants | 544 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 238 | 0 / 306 |
Outcome results
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
Time frame: Pregnancy period through 6 to 8 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hospital With Immunization Program | Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns | 55 Percentage of All Household Contacts |
| Hospital With No Immunization Program | Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns | 39 Percentage of All Household Contacts |
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
Time frame: Pregnancy period through 6 to 8 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hospital With Immunization Program | Influenza Vaccine Coverage (Percent) for New Fathers of Newborns | 53 Percentage of Fathers of Newborns |
| Hospital With No Immunization Program | Influenza Vaccine Coverage (Percent) for New Fathers of Newborns | 26 Percentage of Fathers of Newborns |
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
Time frame: Pregnancy period through 6 to 8 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hospital With Immunization Program | Influenza Vaccine Coverage (Percent) for New Mothers of Newborns | 70 Percentage of Participants |
| Hospital With No Immunization Program | Influenza Vaccine Coverage (Percent) for New Mothers of Newborns | 64 Percentage of Participants |