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Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
FluMist
FluMist
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

12 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 12 to 15 months of age (not reached their 16th month birthday); In good health; Parent/guardian available by telephone or for home visits; Ability of the parent/guardian to understand and comply with the requirements of the protocol; Signed informed consent by parent/guardian; and Up to date with the primary series of recommended vaccines per standard clinic practice and local vaccine availability. Exclusion Criteria: Previous known measles, mumps, rubella or varicella disease; Previous vaccination against measles, mumps, rubella or varicella disease; Hypersensitivity to egg or egg protein; Signs or symptoms of any immunosuppressive or immune deficiency disease or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household; Acute febrile (>100.0oF [37.8°C] oral) illness or clinically significant upper respiratory illness within the 72 hours prior to enrollment; Use of aspirin (acetylsalicylic acid) or aspirin-containing products in the month prior to enrollment, or expected use of aspirin while enrolled in this study; Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study; Administration of any live virus vaccine within one month prior to enrollment through 30 days after Visit 3; Administration of any inactivated vaccine within two weeks prior to enrollment through 30 days after Visit 3; Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; Receipt of any blood product within three months prior to vaccination or expected receipt within the study duration; and Any condition which, in the opinion of the investigator, would interfere with the interpretation or evaluation of the vaccines. History of two or more episodes of medically attended wheezing illness by parent/guardian report. History of medically attended wheezing illness or bronchodilator medication use within four weeks of enrollment by parent/guardian report.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    2

    3

    1

    Arm Description

    FluMist

    Placebo

    FluMist with other solution

    Outcomes

    Primary Outcome Measures

    compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children

    Secondary Outcome Measures

    Compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    February 7, 2008
    Sponsor
    MedImmune LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00192491
    Brief Title
    Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children
    Official Title
    A Randomized, Placebo-Controlled, Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, (MMRIIÒ) and Varicella (VARIVAXÒ) Vaccines Administered Concurrently to Healthy Children (AV018)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2000 (undefined)
    Primary Completion Date
    September 2003 (Anticipated)
    Study Completion Date
    December 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    MedImmune LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1). To compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary: To assess the safety and tolerability of concurrent administration of FluMist with MMRIIÒ and VARIVAXÒ.

    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 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    FluMist
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    FluMist with other solution
    Intervention Type
    Biological
    Intervention Name(s)
    FluMist
    Intervention Description
    Nasal Sprayer of one dosage of FluMist and other experimental
    Intervention Type
    Biological
    Intervention Name(s)
    FluMist
    Intervention Description
    Nasal sprayer of FluMist
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Nasal Sprayer of Placebo
    Primary Outcome Measure Information:
    Title
    compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children
    Time Frame
    Day 42
    Secondary Outcome Measure Information:
    Title
    Compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist
    Time Frame
    Day 42

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    15 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 12 to 15 months of age (not reached their 16th month birthday); In good health; Parent/guardian available by telephone or for home visits; Ability of the parent/guardian to understand and comply with the requirements of the protocol; Signed informed consent by parent/guardian; and Up to date with the primary series of recommended vaccines per standard clinic practice and local vaccine availability. Exclusion Criteria: Previous known measles, mumps, rubella or varicella disease; Previous vaccination against measles, mumps, rubella or varicella disease; Hypersensitivity to egg or egg protein; Signs or symptoms of any immunosuppressive or immune deficiency disease or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household; Acute febrile (>100.0oF [37.8°C] oral) illness or clinically significant upper respiratory illness within the 72 hours prior to enrollment; Use of aspirin (acetylsalicylic acid) or aspirin-containing products in the month prior to enrollment, or expected use of aspirin while enrolled in this study; Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study; Administration of any live virus vaccine within one month prior to enrollment through 30 days after Visit 3; Administration of any inactivated vaccine within two weeks prior to enrollment through 30 days after Visit 3; Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; Receipt of any blood product within three months prior to vaccination or expected receipt within the study duration; and Any condition which, in the opinion of the investigator, would interfere with the interpretation or evaluation of the vaccines. History of two or more episodes of medically attended wheezing illness by parent/guardian report. History of medically attended wheezing illness or bronchodilator medication use within four weeks of enrollment by parent/guardian report.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Walker, M.D.
    Organizational Affiliation
    MedImmune LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18310199
    Citation
    Nolan T, Bernstein DI, Block SL, Hilty M, Keyserling HL, Marchant C, Marshall H, Richmond P, Yogev R, Cordova J, Cho I, Mendelman PM; LAIV Study Group. Safety and immunogenicity of concurrent administration of live attenuated influenza vaccine with measles-mumps-rubella and varicella vaccines to infants 12 to 15 months of age. Pediatrics. 2008 Mar;121(3):508-16. doi: 10.1542/peds.2007-1064.
    Results Reference
    derived

    Learn more about this trial

    Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children

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