Status:
COMPLETED
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Influenza
Eligibility:
All Genders
6-36 years
Phase:
PHASE2
Brief Summary
To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, triv...
Detailed Description
This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 mo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00192322
Start Date
September 1 2001
End Date
December 1 2001
Last Update
February 17 2012
Active Locations (2)
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1
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
2
Division of Allergy Immunology and Infectious Disease
Pittsburgh, Pennsylvania, United States, 15213