Comparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment

Completed · Phase 4

Conditions studied: Influenza

In brief

The purpose of this study is to evaluate how young children's bodies learn to fight against flu infection and to see how vaccines may help to fight against the flu. This is a Phase 4, single-center, randomized study of the immune responses of 40 children, ages 5-9, given one of two licensed influenza vaccines (either inactivated vaccine given in an arm muscle or live, attenuated vaccine inhaled through the nose). Study procedures will include up to 3 blood samples. Participants will complete a diary to document any side effects experienced following the vaccination. Participants will return to the clinic for a visit on Day 7-9 and again 4-6 weeks following vaccination. Participants that have not been previously vaccinated will receive a 2nd dose of vaccine. A follow up telephone call will occur 8-10 weeks following vaccination. Total study participation will be up to 75 days.

Key facts

Study ID

NCT00138385

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Starts

2005-08-01

Expected to finish

2007-06-01

Last updated by the study team

2010-08-27

Who can join

Age: 5 and older, up to 9. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy children aged 5-9 years of age.
• Parents willing to sign informed consent.
• Availability for follow-up for the planned duration of the study at least 4 weeks after last immunization.
• Acceptable medical history by screening evaluation and brief clinical assessment.

You may not qualify if…

• History of immunodeficiency.
• Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
• Household contact with immunodeficiency due to disease, medication or radiation.
• Child receiving aspirin therapy or aspirin-containing therapy.
• History of Guillain-Barré syndrome.
• Malignancy, other than squamous cell or basal cell skin cancer.
• Autoimmune disease.
• History of asthma or reactive airways disease.
• Chronic cardiovascular and pulmonary disorder.
• Chronic metabolic diseases (including diabetes), renal dysfunction or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
• Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
• Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol.
• Inactivated vaccine 14 days prior to vaccination.
• Live, attenuated vaccines within 60 days of study.
• Use of investigational agents within 30 days prior to study.
• Receipt of blood products or immunoglobulin in the past 6 months.
• Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment.
• Acute febrile illness on the day of vaccination.
• Known allergies to any component of the vaccine, including thimerosal.
• History of allergy to eggs or egg products.
• Any condition that, in the opinion of the investigator, might interfere with study objectives.

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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