Clinical trial NCT00344305: A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: children, FluMist, shedding,
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2006-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 participants was stratified by age, with 100 participants 6 to \< 24 months of age (who reached their sixth month but not their second year birthday) and 100 participants 24 to \< 60 months of age (who reached their second year but not their fifth year birthday). Baseline medical history data collection included the participants prior receipt of influenza vaccine or history of laboratory-confirmed influenza illness in the previous influenza season.

Eligibility 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 Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the participants parent/legal representative
* Ability of the participants parent/legal representative to understand and comply with the requirements of the study
* Participants 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 (greater than or equal to \[\>=\] 100.0 degree Fahrenheit \[°F\] 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 human immunodeficiency virus \[HIV\] infection), or ongoing receipt of any immunosuppressive therapy
* Household contact who was immunocompromised (participants 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

Primary outcomes:
measure: Percentage of Participants Who Shed Any Vaccine Virus
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Percentage of Participants Who Shed A/H1N1 Vaccine Virus
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Percentage of Participants Who Shed A/H3N2 Vaccine Virus
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Percentage of Participants Who Shed B Vaccine Virus
timeFrame: Days 1-28 after study vaccination (up to Day 28)
Secondary outcomes:
measure: Duration of Any Vaccine Virus Shedding
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Duration of Confirmed A/H1N1 Vaccine Virus Shedding
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Duration of Confirmed A/H3N2 Vaccine Virus Shedding
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Duration of Confirmed B Vaccine Virus Shedding
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Quantitation of Confirmed B Shed Vaccine Virus on Any Day
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
timeFrame: Days 1-28 after study vaccination (up to Day 28)
measure: Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
timeFrame: Days 0-28 after vaccination (up to Day 28)
measure: Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
timeFrame: Days 0-180 after vaccination (up to 6.5 months)
measure: Number of Participants With REs in Relation to Any Vaccine Virus Shedding
timeFrame: Days 0-28 after study vaccination (up to Day 28)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma Clinic, PA
state: Arkansas
city: Marietta
country: United States
facility: Pediatric and Adolescent Medicine, PA (PAMPA)
state: Georgia
city: Bardstown
country: United States
facility: Kentucky Pediatrics/Adult Research
state: Kentucky
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Cortland
country: United States
facility: Health Sciences Research Center
state: New York
city: Elmira
country: United States
facility: Health Sciences Research Center
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research Inc.
state: New York
city: Oklahoma City
country: United States
facility: Grand Prairie Pediatrics & Allergy Clinic
state: Oklahoma
city: Pittsburgh
country: United States
facility: Primary Physicians Research , Inc
state: Pennsylvania
city: Houston
country: United States
facility: Med-Pro Research Inc.
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Provo
country: United States
facility: Utah Valley Pediatrics
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: MedImmune LLC
name: Raburn Mallory, M.D.
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.vaccine.2011.04.022. Epub 2011 Apr 20.