Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children

Completed · Phase 2 · Has a placebo group

Conditions studied: Influenza

In brief

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, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA). • To assess nasal swab specimens to detect vaccine virus shedding.

Key facts

Study ID

NCT00192322

Run by

MedImmune LLC

People needed

173

Starts

2001-09-01

Expected to finish

2001-12-01

Last updated by the study team

2012-02-17

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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);

You may not qualify if…

• 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.

Where it is running

• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Division of Allergy Immunology and Infectious Disease — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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