A Phase 2 interventional study of CAIV-T 10^7 and CAIVT 10^5 in Influenza, sponsored by MedImmune LLC. Completed at 2 sites in United States. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-17.
Sponsored by MedImmune LLC · Phase 2, Interventional, and Prevention
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).
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).
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 173 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
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Exclusion Criteria:
Note: A pregnant household member is not considered a contraindication to enrollment.
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 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 placebo
Biological: Placebo
A single intramuscular injection of commercially available vaccine
Biological: TIV
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
commercially available TIV injected intramuscularly
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
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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