Feasibility of Cocooning Immunization Strategy With Influenza Vaccine

NCT00570037 | Completed Results

• 2 other identifiers: Pro000049901U01IP000074-01
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza

Keywords

Influenza; Vaccine; Children

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Immunization Program

ACTIVE COMPARATOR

Intervention Hospital - Standing postpartum vaccine orders, influenza vaccine clinic on postpartum ward for household contacts, mailed vaccine reminders

Biological: Trivalent inactivated influenza vaccine

No Immunization Program

NO INTERVENTION

Comparison Hospital - Receipt of vaccine through routine clinical care

Interventions

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

Also known as: Fluzone

Immunization Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mother of a newborn delivered at either Durham Regional Hospital or Duke University Hospital between October 2007 and February 2008

You may not qualify if:

• Fetal demise or stillbirth
• Maternal rights relinquished
• Language barrier

Sponsors & Collaborators

• Duke University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Durham Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Emmanuel Walter MD, Principal Investigator
• Organization: Duke University Medical Center

walte002@mc.duke.edu

919-620-5374

Study Officials

• Emmanuel B Walter, MD, MPH

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 24, 2013
• Results First Posted: February 1, 2011

Record last verified: 2011-01

Locations

US (2)