Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children
Phase 3
Completed
- Conditions
- Respiratory Tract Infections
- Registration Number
- NCT00192205
- Lead Sponsor
- MedImmune LLC
- Brief Summary
- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.
- Detailed Description
* The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age.
* The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2200
Inclusion Criteria
- who are aged at least 6 months and less than 72 months of age at the time of enrolment;
- who have experienced two or more practitioner attended RTIs* in the past 12 months (since birth if less than 12 months old); * RTIs are defined as upper RTIs including (but not limited to) common cold, acute otitis media and lower RTIs including (but not limited to) bronchiolitis, bronchitis and pneumonia.
- whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;
- who, along with their parent(s)/legal guardian(s), will be available for duration of the trial;
- whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
Exclusion Criteria
- whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
- with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
- with Down's syndrome or other known cytogenetic disorders;
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids of a dose equivalent to (i) 2mg/kg/day or greater of Prednisolone or (ii) equivalent to a total of 20 mg/day or greater for children who weigh more than 10kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 27;
- who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
- for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrolment through to the conclusion of the study;
- who have an immunosuppressed or an immunocompromised individual living in the same household;
- who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) or is anticipated to receive a non-study influenza vaccine after enrollment;
- with a documented history of hypersensitivity to egg or egg protein or any other component of CAIV-T or TIV;
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrolment or for which use is anticipated during the study;
- with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results;
Note: Pregnancy in any person who has regular contact with the subject is not a contraindication to the enrolment or ongoing participation of the subject in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine
- Secondary Outcome Measures
Name Time Method To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs
Trial Locations
- Locations (2)
Hospital de Txagorritxu
🇪🇸Vitoria, Spain
Schneider Children's Medical Center of Israel
🇮🇱Petah-Tikva, Israel