Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With (TIV)

MedImmune

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: CAIV-T

Other: TIV

Study type

Interventional

Funder types

Industry

Identifiers

NCT00111579

MI-CP123

Details and patient eligibility

About

The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and TIV against homotypic and heterotypic influenza virus strains.

Sex

All

Ages

6 to 36 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or Female
Ages 6 to but less than 36 months (reached their 6th month but have not yet reached their 3rd birthday) at the time of randomization
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the participant's parent/legal representative
Ability of the parent/legal representative to understand and comply with the requirements of the study
Parent/legal representative available by telephone
Ability to complete follow-up period of 180 days after final study vaccination, as required by the protocol

Exclusion criteria

History of hypersensitivity to any component of CAIV-T or TIV, including egg or egg products, monosodium glutamate, porcine gelatin or thimerosal
History of hypersensitivity to gentamicin
Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination)
History of Guillain-Barre syndrome
Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to randomization (i.e., children with recent persistent asthma are excluded); or history of severe persistent asthma, according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma - Update on Selected Topics 2002
Acute febrile (not greater than 100.0 degrees F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination
Use of aspirin or aspirin-containing products within 30 days prior to randomization, or expected use through 180 days after final study vaccination
Receipt of any prior influenza vaccine
Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected use through 180 days after final study vaccination
Administration of any live virus vaccine within 30 days prior to randomization, or expected receipt through 30 days after final study vaccination
Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization, or expected receipt within 14 days before, or 14 days after, either study vaccination
Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after final study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
Receipt of any blood product within 90 days prior to randomization, or expected receipt through 180 days after final study vaccination
Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
Any condition that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of the study results