Status:
COMPLETED
Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Respiratory Tract Infections
Eligibility:
All Genders
6-71 years
Phase:
PHASE3
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 lea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT00192205
Start Date
October 1 2002
End Date
June 1 2003
Last Update
October 3 2006
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
2
Hospital de Txagorritxu
Vitoria-Gasteiz, Spain