Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Live attenuated influenza vaccine; Inactivated influenza vaccine
Intervention description: One dose of live attenuated influenza vaccine, according to routine immunization recommendations; One dose of inactivated influenza vaccine, according to routine immunization recommendations
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 24 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; premature infant; very low birth weight infant; immunization; vaccine

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 other children. The recently-licensed live attenuated influenza
      vaccine (LAIV) promotes better immune responses than the trivalent inactivated vaccine, but
      can cause wheezing. The balance of risks and benefits for LAIV in extremely premature
      infants, who may be at increased risk for both influenza disease and vaccine side effects, is
      unknown.

      The specific aim of this project is to compare the immune response and reactions of
      trivalent, inactivated influenza vaccine (TIV) and live, attenuated, intranasal influenza
      vaccine (LAIV) in groups of former premature (PT), very (V) LBW and former full-term (FT)
      infants aged 24-35 months.

      The investigators hypothesize that the immune response in FT infants will be greater with
      LAIV than TIV, and that wheezing episodes will be no more than twice as frequent in LAIV as
      in TIV recipients.

      The study will enroll 14 former premature, VLBW infants and 14 former full-term infants.
      Children will be randomized to receive one dose either TIV or LAIV. Vaccine reactions will be
      measured. One to two teaspoons mL of blood will be drawn at 0 and 7-14 days from
      immunization, and less than one teaspoon of blood will be drawn at 28-42 days.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all relevant criteria (by time of influenza vaccination) to participate.

          1. (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.

          2. Influenza immunization in prior season.

          3. Eligible for either influenza immunization (TIV or LAIV).

          4. Parental permission.

          5. Parents likely to be able to comply with study visits.

        Exclusion Criteria:

        Subjects may not participate if they meet any one of these criteria.

          1. Known immunodeficiency in child or in a close household contact.

          2. History of:

               -  Recurrent episodes of wheezing,

               -  Medically-attended wheezing illness in past year, or

               -  Hospitalization for a wheezing illness.

          3. Systemic corticosteroid administration at time of influenza vaccination.

          4. Requiring supplemental oxygen at time of influenza vaccination.

          5. Contraindication to either influenza immunization (e.g. egg allergy, aspirin therapy).

          6. Physician-diagnosed influenza illness in the current influenza season.

          7. Any condition determined by investigator as likely to interfere with evaluation of the
             vaccine or be a significant potential health risk to the subject.