A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children - Full Text View

Purpose

Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.

Condition	Intervention	Phase
Healthy	Biological: Trivalent influenza virus vaccine live, intranasal	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Open-Label, Single Arm Trial to Evaluate the Shedding and Safety of CAIV-T Administered to Children 6 to Less Than 60 Months of Age

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Number of Subjects Who Shed Vaccine Virus (Virus in the Nose of the Recipient That Was Recovered and Cultured From Respiratory Secretions Following Vaccination) [ Time Frame: Day 1-28 after study vaccination ] [ Designated as safety issue: No ]
Subjects were evaluated for viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 [B/Shanghai/361/2002-like]) by collection of nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Subjects whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.

Secondary Outcome Measures:

Duration of Any Vaccine Virus Shedding [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.
Duration of Confirmed Vaccine A/H1N1 Virus Shedding [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.
Duration of Confirmed Vaccine A/H3N2 Virus Shedding [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.
Duration of Confirmed Vaccine B Virus Shedding [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.
Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
This was evaluated using log transformed mean tissue culture infective dose (TCID50) for each virus strain (maximum viral quantification per strain per subject) and summarized for all subjects who shed vaccine virus and by age group.
Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
This was evaluated using log (TCID50) for each virus strain and summarized for all subjects who shed vaccine virus and by age group.
Quantitation of Confirmed B Shed Vaccine Virus on Any Day [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
This was evaluated using log (TCID50) for each virus strain and summarized for all subjects who shed vaccine virus and by age group.
Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
Laboratory phenotypic and genotypic data were summarized by treatment and age group for subjects who shed vaccine virus.
Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
Laboratory phenotypic and genotypic data were summarized by treatment and age group for subjects who shed vaccine virus.
Genotypic and Phenotypic Stability of B Shed Vaccine Virus [ Time Frame: Days 1-28 after study vaccination ] [ Designated as safety issue: No ]
Laboratory phenotypic and genotypic data were summarized by treatment and age group for subjects who shed vaccine virus.
Number of Subjects Reporting Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination [ Time Frame: Days 0-28 after vaccination ] [ Designated as safety issue: Yes ]
Reactogenicity events were predifined solicited events that could potentially occure after vaccination. The REs for this study included: fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain, muscle ache, chills, decreased activity level, decreased appetite, and irritability.
Number of Subjects Reporting Serious Adverse Events and Significant New Medical Conditions Through 180 Days Post Vaccination [ Time Frame: Days 0-180 after vaccination ] [ Designated as safety issue: Yes ]
Number of Subjects Reporting REs in Relation to Any Vaccine Virus Shedding [ Time Frame: Days 0-28 after study vaccination ] [ Designated as safety issue: Yes ]
The REs for this study included: fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain, muscle ache, chills, decreased activity level, decreased appetite, and irritability.

Enrollment:	200
Study Start Date:	May 2006
Study Completion Date:	December 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Trivalent influenza virus vaccine live, intranasal A single intranasal dose 10^7 fluorescent focus units (FFU) of trivalent influenza virus vaccine live, intranasal was administered on Day 0.	Biological: Trivalent influenza virus vaccine live, intranasal A single intranasal dose of trivalent influenza virus vaccine live, intranasal was administered on Day 0. Other Names: FluMist CAIV-T LAIV

Detailed Description:

This was a Phase 2, open-label, single-arm, multicenter study designed to evaluate vaccine virus shedding and safety of trivalent influenza virus vaccine live, intranasal in children 6 to < 60 months of age. Enrollment of approximately 200 subjects was stratified by age, with 100 subjects 6 to < 24 months of age (who reached their sixth month but not their second year birthday) and 100 subjects 24 to < 60 months of age (who reached their second year but not their fifth year birthday). Baseline medical history data collection included the subject's prior receipt of influenza vaccine or history of laboratory-confirmed influenza illness in the previous influenza season.

Eligibility

Ages Eligible for Study:	6 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female, 6 months to less than 60 months of age (reached their 6th month but not yet reached their 5th year birthday) at the time of study vaccination
Written informed consent and HIPAA authorization obtained from the subject's parent/legal representative
Ability of the subject's parent/legal representative to understand and comply with the requirements of the study
Subject's parent/legal representative available by telephone
Ability to complete follow-up period of 180 days after study vaccination as required by the protocol

Exclusion Criteria:

History of hypersensitivity to any component of trivalent influenza virus vaccine live, intranasal, including egg or egg products, monosodium glutamate, or porcine gelatin
History of hypersensitivity to gentamicin
History of Guillain-Barré syndrome
Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to study vaccination (i.e., children with recent persistent asthma were excluded); or history of severe persistent asthma according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report
Acute febrile (≥100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to study vaccination
Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
Household contact who was immunocompromised (subjects were also to avoid close contact with immunocompromised individuals for at least 21 days after study vaccination)
Use of aspirin or aspirin-containing products within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination
Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
Use of any intranasal medication within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
Administration of any live virus vaccine within the 30 days prior to study vaccination, or expected receipt through 30 days after study vaccination
Administration of any inactivated (i.e., non-live) vaccine within the 14 days prior to study vaccination, or expected receipt through 14 days after study vaccination
Receipt of any investigational agent within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert was permitted)
Receipt of any blood product within the 90 days prior to study vaccination, or expected receipt through 28 days after study vaccination
Family member or household contact who was an employee of the research center or otherwise involved with the conduct of the study
Any condition that in the opinion of the investigator would have interfered with evaluation of the vaccine or interpretation of study results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344305

Locations

United States, Arkansas
Little Rock Allergy & Asthma Clinic, PA
Little Rock, Arkansas, United States, 72205
United States, Georgia
Pediatric and Adolescent Medicine, PA (PAMPA)
Marietta, Georgia, United States, 30062
United States, Kentucky
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, United States, 40004
United States, Louisiana
Benchmark Research
Metarie, Louisiana, United States, 70006
United States, New York
Health Sciences Research Center
Courtland, New York, United States, 13045
Health Sciences Research Center
Elmira, New York, United States, 14901
Regional Clinical Research Inc.
Endwell, New York, United States, 13760
United States, Oklahoma
Grand Prairie Pediatrics & Allergy Clinic
Oklahoma City, Oklahoma, United States, 73132
United States, Pennsylvania
Primary Physicians Research , Inc
Pittsburgh, Pennsylvania, United States, 15241
United States, Texas
Med-Pro Research Inc.
Houston, Texas, United States, 77004
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Benchmark Research
San Angelo, Texas, United States, 76904
United States, Utah
Wee Care Pediatrics
Layton, Utah, United States, 84041
Utah Valley Pediatrics
Provo, Utah, United States, 84604
United States, Virginia
PI-Coor Clinical Research, LLC
Burke, Virginia, United States, 22015
Advanced Pediatrics
Vienna, Virginia, United States, 22180

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Raburn Mallory, M.D.

MedImmune LLC, an affiliate of AstraZeneca AB

More Information

Publications:

Mallory RM, Yi T, Ambrose CS. Shedding of Ann Arbor strain live attenuated influenza vaccine virus in children 6-59 months of age. Vaccine. 2011 Jun 10;29(26):4322-7. Epub 2011 Apr 20.

Responsible Party:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00344305 History of Changes
Other Study ID Numbers:	MI-CP129
Study First Received:	June 22, 2006
Results First Received:	July 29, 2010
Last Updated:	September 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

children, FluMist, shedding,

ClinicalTrials.gov processed this record on May 16, 2013