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Sponsors and Collaborators: |
MedImmune LLC Wyeth |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00192374 |
- Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of(CAIV-T) in Healthy Children.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Biological: CAIV-T, Liquid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment |
Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B,Live, Cold-Adapted (CAIV-T) in Healthy Children |
Estimated Enrollment: | 1920 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | November 2002 |
- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children
Ages Eligible for Study: | 6 Months to 35 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
•who are aged at least 6 months and less than 36 months of age at the time of first vaccination
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
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.
Philippines | |
Department of Microbiology, Research Institute for Tropical Medicine | |
Muntinlupa City, Philippines | |
Thailand | |
Queen Sirikit National Institute of Child Health (Children's Hospital) | |
Bangkok, Thailand, 10400 |
Principal Investigator: | Tawee Chotpitayasunondh, Dr. | Queen Sirikit National Institute of Child Health (Children's Hospital) |
Principal Investigator: | Rosario Z. Capeding, Dr. | Department of Microbiology, Research Institute for Tropical Medicine |
Study ID Numbers: | D153-P513 |
Study First Received: | September 12, 2005 |
Last Updated: | October 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00192374 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Influenza, Human Healthy |