Clinical trial NCT00192283: Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children Attending Day Care Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-19
Enrollment: 2903
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months, attending day care centers in Europe. In addition, the trial provides the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare resource utilization and economic resources.


Eligibility criteria: Inclusion Criteria:

* who are aged at least 6 months and less than 36 months of age at the time of enrollment, attending day care for at least three days a week, four hours a day;
* who are in good health as determined by medical history, physical examination and clinical judgement;
* 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 (8 months ± 1 month);
* 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; 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 enrollment through to the conclusion of the study;
* 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);
* who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational);
* with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
* with a clinically confirmed respiratory illness with wheezing within two weeks prior to enrollment;
* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
* who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study;
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.

Note: A pregnant household member is not considered a contraindication to enrollment.

Primary outcomes:
measure: The primary endpoint for efficacy is the first episode in a study child of a cultureconfirmed influenza illness.
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: The secondary endpoint for culture-confirmed influenza illness is the first episode caused by any community-acquired antigenic subtype which occurs following receipt of the second dose of study vaccine or placebo.
timeFrame: 28 days after vaccination
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Medical School
Study officials:
affiliation: MedImmune LLC
name: Robert Walker, MD
role: STUDY_DIRECTOR
References: