Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

MedImmune

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Drug: Liquid CAIV-T

Study type

Interventional

Funder types

Industry

Identifiers

NCT00128167

MI-CP111

Details and patient eligibility

About

The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.

Sex

All

Ages

6 to 59 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 6-59 months of age (not yet reached their 5th birthday)
Parent or guardian available by telephone
Available for illness visits at clinic or at home during the influenza surveillance period
Written informed consent (and Health Insurance Portability and Accountability Act [HIPAA] authorization for U.S. Participants) obtained from the participant's parent or legal guardian and
Ability of the parent/guardian to understand and comply with the requirements of the protocol

Exclusion criteria

History of hypersensitivity to any component of CAIV-T or inactivated influenza vaccine, including egg or egg protein
History of hypersensitivity to gentamicin
Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
History of Guillain-Barre syndrome
Medically-diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled) within the previous 42 days by parent report or chart review (e.g., children with recent persistent asthma are excluded), or history of severe asthma
Acute febrile (>100.0 degrees F or >37.8 degrees C oral or equivalent) illness or acute respiratory illness, including sore throat, within three days prior to enrollment
Receipt of an investigational product within 30 days prior to enrollment or expected receipt during this study
Use of aspirin or salicylate-containing products 30 days prior to enrollment or expected receipt during this study
Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt during this study
Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study
Administration of any live virus vaccine within 30 days prior to enrollment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination
Administration of any inactivated vaccine within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination
Close contact who is severely immunocompromised (e.g., transplant recipient)
Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study and
Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.