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

NCT ID: NCT00344305

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-01
• Study Completion Date: 2006-12-01

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Participants Between 6 to < 24 Months Age

Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

Group Type: EXPERIMENTAL

Trivalent influenza virus vaccine live, intranasal

Intervention Type: BIOLOGICAL

A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains.

Cohort 2: Participants Between 24 to < 60 Months Age

Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

Group Type: EXPERIMENTAL

Trivalent influenza virus vaccine live, intranasal

Intervention Type: BIOLOGICAL

A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains.

Interventions

Trivalent influenza virus vaccine live, intranasal

A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains.

Intervention Type: BIOLOGICAL

Other Intervention Names

FluMist; Cold-adapted influenza virus vaccine, trivalent (CAIV-T); Live attenuated influenza virus (LAIV)

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raburn Mallory, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Little Rock Allergy & Asthma Clinic, PA

Little Rock, Arkansas, United States

Pediatric and Adolescent Medicine, PA (PAMPA)

Marietta, Georgia, United States

Kentucky Pediatrics/Adult Research

Bardstown, Kentucky, United States

Benchmark Research

Metairie, Louisiana, United States

Health Sciences Research Center

Cortland, New York, United States

Health Sciences Research Center

Elmira, New York, United States

Regional Clinical Research Inc.

Endwell, New York, United States

Grand Prairie Pediatrics & Allergy Clinic

Oklahoma City, Oklahoma, United States

Primary Physicians Research , Inc

Pittsburgh, Pennsylvania, United States

Med-Pro Research Inc.

Houston, Texas, United States

Central Texas Health Research

New Braunfels, Texas, United States

Benchmark Research

San Angelo, Texas, United States

Wee Care Pediatrics

Layton, Utah, United States

Utah Valley Pediatrics

Provo, Utah, United States

PI-Coor Clinical Research, LLC

Burke, Virginia, United States

Advanced Pediatrics

Vienna, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21513761 (View on PubMed)

Other Identifiers

MI-CP129

Identifier Type: -

Identifier Source: org_study_id