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Completed

NCT Number: NCT00570037

Feasibility of Cocooning Immunization Strategy With Influenza Vaccine

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Fluzone

Primary outcomes

  1. Influenza Vaccine Coverage (Percent) for New Mothers of Newborns

    Time frame: 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

  2. Influenza Vaccine Coverage (Percent) for New Fathers of Newborns

    Time frame: 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

  3. Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Prevention of Influenza in Infants by Immunization of Their Contacts in the Household

Acronym: Piiitch

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 10, 2007
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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