Status:
TERMINATED
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Lead Sponsor:
University of Rochester
Conditions:
Influenza
Eligibility:
All Genders
24-35 years
Phase:
PHASE4
Brief Summary
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in...
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
- Subjects must meet all relevant criteria (by time of influenza vaccination) to participate.
- (a) Former premature (\<32 weeks' gestation at birth), VLBW (\<1500 grams' birth weight) infant, 24 months, 0 days - 35 months, 31 days of age, OR (b) Former full-term (37-42 weeks' gestation at birth), normal birth weight (\>2500 grams' birth weight) infant, 24 months, 0 days - 35 months, 31 days of age.
- Influenza immunization in prior season.
- Eligible for either influenza immunization (TIV or LAIV).
- Parental permission.
- Parents likely to be able to comply with study visits.
Exclusion
- Subjects may not participate if they meet any one of these criteria.
- Known immunodeficiency in child or in a close household contact.
- History of:
- Recurrent episodes of wheezing,
- Medically-attended wheezing illness in past year, or
- Hospitalization for a wheezing illness.
- Systemic corticosteroid administration at time of influenza vaccination.
- Requiring supplemental oxygen at time of influenza vaccination.
- Contraindication to either influenza immunization (e.g. egg allergy, aspirin therapy).
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01194297
Start Date
August 1 2010
End Date
May 1 2012
Last Update
August 22 2014
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