Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children (CAIVT)
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.
|Influenza||Biological: CAIV-T 10^7 Biological: CAIVT 10^5 Biological: Placebo Biological: TIV||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official 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|
- Measurement of influenza-specific immune response following receipt of CAIV-T. [ Time Frame: Day 0 and Day 27 ]The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
- Vaccine virus shedding [ Time Frame: Days 2, 6, and 13 ]The number of subjects who shed influenza virus vaccine subtypes following vaccination.
- Measurement of influenza-specific immune response following receipt of CAIVT. [ Time Frame: Day 0 and Day 27 ]The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples.
- Measurement of influenza-specific immune responses following receipt of CAIVT [ Time Frame: Day 0, Day 6, and Day 13 ]The immune responses were evaluated by assays of cellular immunity (IFN-gamma ELISPOT) and assays that measured the number of antibody secreting cells (B-cell ELISPOT).
- Assess the safety and tolerability of CAIV-T vaccine in healthy children. [ Time Frame: Day 0-27 ]Adverse events and serious adverse events were collect from Day 0 till the end of the study Day 27.
|Study Start Date:||September 2001|
|Study Completion Date:||December 2001|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
Experimental: CAIV-T 10^5
a single intranasal 0.2 mL dose of liquid CAIV-T 10^5 (approximately 0.1 mL into each nostril)
Biological: CAIVT 10^5
a single intranasal 0.2 mL dose of CAIV-T <10^5
Experimental: CAIVT 10^7
A single intranasal 0.2 mL dose of liquid CAIV-T 10^7 (approximately 0.1 mL into each nostril)
Biological: CAIV-T 10^7
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
Placebo Comparator: Placebo
A single intranasal 0.2 mL dose of placebo
a single intranasal 0.2 mL dose of placebo
Active Comparator: Trivalent inactivated vaccine (TIV)
A single intramuscular injection of commercially available vaccine
commercially available TIV injected intramuscularly
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192322
|United States, Florida|
|Suncoast Clinical Research, Inc.|
|New Port Richey, Florida, United States, 34652|
|United States, Pennsylvania|
|Division of Allergy Immunology and Infectious Disease|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Robert Walker, MD||MedImmune LLC|