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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00192322
Date of registration: 12/09/2005
Primary sponsor: MedImmune LLC
Public title: Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children CAIVT
Scientific title: A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live Cold Adapted (CAIV-T) in Healthy Children Aged 6 to Less Than 36 Months
Date of first enrolment: September 2001
Target sample size: 173
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00192322
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
United States
Contacts
Name:   Robert Walker, MD
Address: 
Telephone:
Email:
Affiliation:  MedImmune LLC
Key inclusion & exclusion criteria

Inclusion Criteria:

- children at least 6 months of age and less than 36 months of age at the time of
enrollment, and in good health as determined by medical history, physical examination
and clinical judgement;

- whose parent/legal guardian has provided written informed consent after the nature of
the study has been explained;

- who, along with their parent or guardian, will be available for the one month
duration of the trial (from enrollment to study completion);

Exclusion Criteria:

- whose parents or guardians 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, or cytotoxic agents
(see Section 4.2.2);

- have an immunosuppressed or an immunocompromised individual living in the same
household;

- with a documented history of hypersensitivity to egg or egg protein or any other
component of the study vaccine, placebo or TIV;

- who, at anytime prior to study enrollment, receives any influenza vaccine (commercial
or investigational);

- with any medical conditions that in the opinion of the investigator might interfere
with interpretation of the study results.

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



Age minimum: 6 Months
Age maximum: 36 Months
Gender: Both
Health Condition(s) or Problem(s) studied
Influenza
Intervention(s)
Biological: CAIV-T 10^7
Biological: CAIVT 10^5
Biological: Placebo
Biological: TIV
Primary Outcome(s)
Measurement of influenza-specific immune response following receipt of CAIV-T. [Time Frame: Day 0 and Day 27]
Secondary Outcome(s)
Assess the safety and tolerability of CAIV-T vaccine in healthy children. [Time Frame: Day 0-27]
Measurement of influenza-specific immune responses following receipt of CAIVT [Time Frame: Day 0, Day 6, and Day 13]
Measurement of influenza-specific immune response following receipt of CAIVT. [Time Frame: Day 0 and Day 27]
Vaccine virus shedding [Time Frame: Days 2, 6, and 13]
Secondary ID(s)
D153-P002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Wyeth is now a wholly owned subsidiary of Pfizer
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