Influenza MedDRA version: 3.2 Classification code 10022000
Conditions
Interventions
Product Name: CAIV-T
Pharmaceutical Form: Nasal spray*
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Current Sponsor code: Liquid CAIV-T
Other descriptive name: Intranasal influenza virus
Sponsors
MedImmune Vaccines, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age 6 through 59 months of age (not reached their 5th year birthday at the time of randomization); (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
Exclusion criteria
Exclusion criteria: (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), or history of severe asthma; (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. Note: An individual who initially is excluded from study participation based on one or more of the above time-limited criteria (e.g., acute febrile or acute respiratory illness, etc.) may be reconsidered for enrollment once the condition has resolved. Similarly, in cases of short term, reversible conditions, such as acute febrile or respiratory illness, Dose Two should be deferred until the child has recovered. Also, for children who experienced medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled) within 42 days post Dose One, Dose Two should be deferred until a 42 day wheeze-free and bronchodilator/steroid-free period has elapsed. For children who have received another vaccine or anti-influenza medication in the intervening period, Dose Two should be deferred until the requisite period (14 days for inactivated vaccines and for anti-influenza medications, and 30 days for live vaccines) has elapsed. Subjects will not be permitted to receive their Dose Two medication if it is deferred past January 15, 2005.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. (2) Assess the tolerability of CAIV-T compared to TIV. ;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. For the primary endpoint, culture-confirmed symptomatic influenza infection is defined as the presence of modified CDC-ILI associated with culture-confirmed influenza. Modified CDC-ILI is defined as increased temperature =100°F oral or equivalent plus the presence of cough, sore throat, or runny nose/nasal congestion occurring on the same or consecutive days. | — |
Countries
Czech Republic, Finland, Iceland, Italy, Spain, Sweden
Outcome results
None listed