Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192322
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2005-09-12
Brief Title:
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine CAIV-T in Healthy Children
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Randomized Partially-Blinded Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine TrivalentTypes A B Live Cold Adapted CAIV-T in Healthy Children Aged 6 to Less Than 36 Months
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAIVT
Brief Summary:
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
To assess nasal swab specimens to detect vaccine virus shedding
Detailed Description:
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 Parentsguardians 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 1111 to receive a single intranasal dose of CAIV-T 107 FFU per dose CAIV-T 105 FFU per dose placebo or a commercially-available injectable trivalent influenza vaccine TIV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None