Status:
COMPLETED
Influenza Vaccine in Premature Infants
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Thrasher Research Fund
University of Miami
Conditions:
Influenza
Infant, Premature
Eligibility:
All Genders
6-17 years
Brief Summary
Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have inf...
Detailed Description
Background. Influenza infection causes an estimated 1 million deaths worldwide yearly. Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in h...
Eligibility Criteria
Inclusion
- Inclusion criteria. Subjects must meet all relevant criteria to participate.
- (a) Former premature (\< 30 weeks' gestation at birth), ELBW (\<1001 grams' birth weight) infant, 6 months, 0 days - 17 months, 31 days of age., OR (b) Former full term (37-42 weeks' gestation at birth), normal birth weight (\>2500 grams' birth weight) infant, 6 months, 0 days - 17 months, 31 days of age.
- No prior influenza immunization.
- Eligible for influenza immunization.
- Parental permission.
- Agreement of primary care provider.
- Parents likely to be able to comply with study visits.
- Exclusion criteria. Subjects may not participate if they meet any one of these criteria.
- Known immunodeficiency.
- Systemic corticosteroid administration at time of study enrollment.
- Requiring supplemental oxygen.
- Contraindication to influenza immunization (e.g. egg allergy).
- Physician-diagnosed influenza illness in the current influenza season.
- Any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the subject.
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00455169
Start Date
October 1 2007
End Date
May 1 2008
Last Update
September 17 2015
Active Locations (5)
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1
University of Miami
Miami, Florida, United States, 33101
2
State University of New York at Buffalo
Buffalo, New York, United States, 14222
3
University of Rochester
Rochester, New York, United States, 14534
4
Wake Forest University
Winston-Salem, North Carolina, United States, 27157