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

NCT00344305 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MI-CP129
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 16

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.

Conditions

Healthy

Keywords

children, FluMist, shedding,

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Who Shed Any Vaccine Virus

  Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. 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\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants 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.

  Days 1-28 after study vaccination (up to Day 28)

• Percentage of Participants Who Shed A/H1N1 Vaccine Virus

  Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. 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\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants 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.

  Days 1-28 after study vaccination (up to Day 28)

• Percentage of Participants Who Shed A/H3N2 Vaccine Virus

  Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. 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\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants 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.

  Days 1-28 after study vaccination (up to Day 28)

• Percentage of Participants Who Shed B Vaccine Virus

  Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. 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\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants 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.

  Days 1-28 after study vaccination (up to Day 28)

Secondary Outcomes (13)

• Duration of Any Vaccine Virus Shedding

  Days 1-28 after study vaccination (up to Day 28)

• Duration of Confirmed A/H1N1 Vaccine Virus Shedding

  Days 1-28 after study vaccination (up to Day 28)

• Duration of Confirmed A/H3N2 Vaccine Virus Shedding

  Days 1-28 after study vaccination (up to Day 28)

• Duration of Confirmed B Vaccine Virus Shedding

  Days 1-28 after study vaccination (up to Day 28)

• Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day

  Days 1-28 after study vaccination (up to Day 28)

Study Arms (2)

Cohort 1: Participants Between 6 to < 24 Months Age

EXPERIMENTAL

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).

Biological: Trivalent influenza virus vaccine live, intranasal

Cohort 2: Participants Between 24 to < 60 Months Age

EXPERIMENTAL

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).

Biological: Trivalent influenza virus vaccine live, intranasal

Interventions

Trivalent influenza virus vaccine live, intranasal 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.

Also known as: FluMist, Cold-adapted influenza virus vaccine, trivalent (CAIV-T), Live attenuated influenza virus (LAIV)

Cohort 1: Participants Between 6 to < 24 Months Age; Cohort 2: Participants Between 24 to < 60 Months Age

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (16)

Little Rock Allergy & Asthma Clinic, PA

Little Rock, Arkansas, 72205, United States

Location

Pediatric and Adolescent Medicine, PA (PAMPA)

Marietta, Georgia, 30062, United States

Location

Kentucky Pediatrics/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Health Sciences Research Center

Cortland, New York, 13045, United States

Location

Health Sciences Research Center

Elmira, New York, 14901, United States

Location

Regional Clinical Research Inc.

Endwell, New York, 13760, United States

Location

Grand Prairie Pediatrics & Allergy Clinic

Oklahoma City, Oklahoma, 73132, United States

Location

Primary Physicians Research , Inc

Pittsburgh, Pennsylvania, 15241, United States

Location

Med-Pro Research Inc.

Houston, Texas, 77004, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

Wee Care Pediatrics

Layton, Utah, 84041, United States

Location

Utah Valley Pediatrics

Provo, Utah, 84604, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

Related Publications (1)

• 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.

  PMID: 21513761 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Raburn Mallory MD/ Sr Dir Clinical Development
• Organization: MedImmune, LLC

clinicaltrialenquiries@medimmune.com

301-398-0000

Study Officials

• Raburn Mallory, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 26, 2006
• Study Start: May 1, 2006
• Primary Completion: July 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 24, 2017
• Results First Posted: November 1, 2010

Record last verified: 2017-07

Locations

US (16)