Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants

NCT01194297 | Terminated Phase 4 Results

• 1 other identifier: 25914
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Influenza

Keywords

influenza; premature infant; very low birth weight infant; immunization; vaccine

Outcome Measures

Primary Outcomes (1)

• Humoral Immunogenicity

  Hemagglutinin specific antibody, as measured by hemagglutination inhibition

  28-42 days

Secondary Outcomes (1)

• Medically-attended Wheezing

  42 days

Study Arms (2)

Live attenuated influenza vaccine

EXPERIMENTAL

One dose of live attenuated influenza vaccine, according to routine immunization recommendations

Biological: Live attenuated influenza vaccine

Inactivated influenza vaccine

ACTIVE COMPARATOR

One dose of inactivated influenza vaccine, according to routine immunization recommendations

Biological: Inactivated influenza vaccine

Interventions

Live attenuated influenza vaccine BIOLOGICAL

One dose of live attenuated influenza vaccine, according to routine immunization recommendations

Also known as: FluMist

Live attenuated influenza vaccine

Inactivated influenza vaccine BIOLOGICAL

One dose of inactivated influenza vaccine, according to routine immunization recommendations

Also known as: Fluzone

Inactivated influenza vaccine

Eligibility Criteria

• Age: 24 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

MeSH Terms

Conditions

Influenza, Human; Premature Birth

Interventions

Influenza Vaccines; FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Carl D'Angio
• Organization: University of Rochester

carl_dangio@urmc.rochester.edu

585-275-2972

Study Officials

• Carl T. D'Angio, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 2, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 22, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08