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| Sponsor: | MedImmune LLC |
|---|---|
| Collaborator: |
Wyeth |
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00192400 |
Purpose
The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: CAIV-T |
Phase III |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Single Group Assignment |
| Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children |
| Estimated Enrollment: | 2160 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | November 2002 |
Eligibility| Ages Eligible for Study: | 6 Months to 35 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: (First Season)
(Second Season)
Exclusion Criteria: (First Season)
If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.
Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
(Second Season)
Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
Contacts and Locations
More Information
| Study ID Numbers: | D153-P504 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00192400 History of Changes |
| Health Authority: | United States: Food and Drug Administration |