A Randomized, Double-Blind Trial to Assess the Safety and Relative Efficacy of CAIV-T Against Inactivated Influenza Vaccine in Children 6–59 Months of Age
- Conditions
- InfluenzaMedDRA version: 3.2Classification code 10022000
- Registration Number
- EUCTR2004-000585-13-ES
- Lead Sponsor
- MedImmune Vaccines, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8475
(1) Age 6 through 59 months of age (not reached their 5th year birthday); (2) Parent/guardian available by telephone; (3) Available for illness visits at clinic or at home during the influenza surveillance period; (4) Written informed consent (and HIPAA authorization for US participants) obtained from the participant’s parent or legal guardian; and (5) Ability of the parent/guardian to understand and comply with the requirements of the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
(1) History of hypersensitivity to any component of CAIV-T or inactivated influenza vaccine, including egg or egg protein (2) History of hypersensitivity to gentamicin (3) Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy; (4) History of Guillain-Barre syndrome; (5) 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); (6) Acute febrile (greater than 100.0 degrees Fahrenheit or greater than 37.8 degrees Celsius oral or equivalent) illness or acute respiratory illness, including cough or sore throat, within three days prior to enrollment; (7) Receipt of an investigational product within 30 days prior to enrollment or expected receipt during this study; (8) Use of aspirin or salicylate-containing products 30 days prior to enrollment or expected receipt during this study; (9) Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanazmivir) within 14 days prior to enrollment or expected receipt during this study; (10) Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study; (11) 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; (12) Administration of any inactivated vaccine within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination; (13) Close contact who is severely immunocompromised (e.g. transplant recipient); (14) Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study; and (15) Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluationof the vaccines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.;Secondary Objective: (1) Estimate the relative effectiveness of CAIV-T compared to TIV.<br>(2) Assess the tolerability of CAIV-T compared to TIV.<br>;Primary end point(s): The primary efficacy endpoint of this study is the relative efficacy of CAIV-T compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the influenza surveillance period and at least 14 days after the last required vaccination.
- Secondary Outcome Measures
Name Time Method