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.
This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 months. Parents/guardians of subjects were asked to read and sign the informed consent before any study-related procedures were performed. Subjects at each study site were sequentially assigned to 1 of 2 separate blood sample groups referred to as "cellular immunity" or "antibody secreting cell". Subjects within each blood sample group were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10\^7 FFU per dose, CAIV-T 10\^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza vaccine (TIV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
173
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
a single intranasal 0.2 mL dose of CAIV-T \<10\^5
a single intranasal 0.2 mL dose of placebo
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Division of Allergy Immunology and Infectious Disease
Pittsburgh, Pennsylvania, United States
Measurement of influenza-specific immune response following receipt of CAIV-T.
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
Time frame: Day 0 and Day 27
Vaccine virus shedding
The number of subjects who shed influenza virus vaccine subtypes following vaccination.
Time frame: Days 2, 6, and 13
Measurement of influenza-specific immune response following receipt of CAIVT.
The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples.
Time frame: Day 0 and Day 27
Measurement of influenza-specific immune responses following receipt of CAIVT
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).
Time frame: Day 0, Day 6, and Day 13
Assess the safety and tolerability of CAIV-T vaccine in healthy children.
Adverse events and serious adverse events were collect from Day 0 till the end of the study Day 27.
Time frame: Day 0-27
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commercially available TIV injected intramuscularly