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Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children (CAIVT)

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAIV-T 10^7
CAIVT 10^5
Placebo
TIV
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement; whose parent/legal guardian has provided written informed consent after the nature of the study has been explained; who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion); Exclusion Criteria: whose parents or guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period; with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; with Down's syndrome or other known cytogenetic disorders; with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids, or cytotoxic agents (see Section 4.2.2); have an immunosuppressed or an immunocompromised individual living in the same household; with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine, placebo or TIV; who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational); with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results. Note: A pregnant household member is not considered a contraindication to enrollment.

Sites / Locations

  • Suncoast Clinical Research, Inc.
  • Division of Allergy Immunology and Infectious Disease

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

CAIV-T 10^5

CAIVT 10^7

Placebo

Trivalent inactivated vaccine (TIV)

Arm Description

a single intranasal 0.2 mL dose of liquid CAIV-T 10^5 (approximately 0.1 mL into each nostril)

A single intranasal 0.2 mL dose of liquid CAIV-T 10^7 (approximately 0.1 mL into each nostril)

A single intranasal 0.2 mL dose of placebo

A single intramuscular injection of commercially available vaccine

Outcomes

Primary Outcome Measures

Measurement of influenza-specific immune response following receipt of CAIV-T.
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.

Secondary Outcome Measures

Vaccine virus shedding
The number of subjects who shed influenza virus vaccine subtypes following vaccination.
Measurement of influenza-specific immune response following receipt of CAIVT.
The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples.
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).
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.

Full Information

First Posted
September 12, 2005
Last Updated
February 15, 2012
Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00192322
Brief Title
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
Acronym
CAIVT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAIV-T 10^5
Arm Type
Experimental
Arm Description
a single intranasal 0.2 mL dose of liquid CAIV-T 10^5 (approximately 0.1 mL into each nostril)
Arm Title
CAIVT 10^7
Arm Type
Experimental
Arm Description
A single intranasal 0.2 mL dose of liquid CAIV-T 10^7 (approximately 0.1 mL into each nostril)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single intranasal 0.2 mL dose of placebo
Arm Title
Trivalent inactivated vaccine (TIV)
Arm Type
Active Comparator
Arm Description
A single intramuscular injection of commercially available vaccine
Intervention Type
Biological
Intervention Name(s)
CAIV-T 10^7
Intervention Description
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
Intervention Type
Biological
Intervention Name(s)
CAIVT 10^5
Intervention Description
a single intranasal 0.2 mL dose of CAIV-T <10^5
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
a single intranasal 0.2 mL dose of placebo
Intervention Type
Biological
Intervention Name(s)
TIV
Intervention Description
commercially available TIV injected intramuscularly
Primary Outcome Measure Information:
Title
Measurement of influenza-specific immune response following receipt of CAIV-T.
Description
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
Time Frame
Day 0 and Day 27
Secondary Outcome Measure Information:
Title
Vaccine virus shedding
Description
The number of subjects who shed influenza virus vaccine subtypes following vaccination.
Time Frame
Days 2, 6, and 13
Title
Measurement of influenza-specific immune response following receipt of CAIVT.
Description
The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples.
Time Frame
Day 0 and Day 27
Title
Measurement of influenza-specific immune responses following receipt of CAIVT
Description
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
Title
Assess the safety and tolerability of CAIV-T vaccine in healthy children.
Description
Adverse events and serious adverse events were collect from Day 0 till the end of the study Day 27.
Time Frame
Day 0-27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement; whose parent/legal guardian has provided written informed consent after the nature of the study has been explained; who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion); Exclusion Criteria: whose parents or guardians are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period; with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; with Down's syndrome or other known cytogenetic disorders; with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids, or cytotoxic agents (see Section 4.2.2); have an immunosuppressed or an immunocompromised individual living in the same household; with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine, placebo or TIV; who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational); with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results. Note: A pregnant household member is not considered a contraindication to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Walker, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Division of Allergy Immunology and Infectious Disease
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15545863
Citation
Mendelman PM, Rappaport R, Cho I, Block S, Gruber W, August M, Dawson D, Cordova J, Kemble G, Mahmood K, Palladino G, Lee MS, Razmpour A, Stoddard J, Forrest BD. Live attenuated influenza vaccine induces cross-reactive antibody responses in children against an a/Fujian/411/2002-like H3N2 antigenic variant strain. Pediatr Infect Dis J. 2004 Nov;23(11):1053-5. doi: 10.1097/01.inf.0000143643.44463.b1.
Results Reference
result

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Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children

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