Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children (CAIVT)
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|ClinicalTrials.gov Identifier: NCT00192322|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 17, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: CAIV-T 10^7 Biological: CAIVT 10^5 Biological: Placebo Biological: TIV||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||December 2001|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|