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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00344305
First received: June 22, 2006
Last updated: July 21, 2017
Last verified: July 2017
  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
Intervention Model: Single Group Assignment
Masking: No masking
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:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Percentage of Participants Who Shed Any Vaccine Virus [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    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.

  • Percentage of Participants Who Shed A/H1N1 Vaccine Virus [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    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.

  • Percentage of Participants Who Shed A/H3N2 Vaccine Virus [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    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.

  • Percentage of Participants Who Shed B Vaccine Virus [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    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.


Secondary Outcome Measures:
  • Duration of Any Vaccine Virus Shedding [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    The number of days of shedding was summarized for all participants who shed any vaccine virus.

  • Duration of Confirmed A/H1N1 Vaccine Virus Shedding [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.

  • Duration of Confirmed A/H3N2 Vaccine Virus Shedding [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.

  • Duration of Confirmed B Vaccine Virus Shedding [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    The number of days of shedding was summarized for all participants who shed confirmed B strain virus.

  • Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    Quantitation of confirmed A/H1N1 shed vaccine virus was evaluated using the log transformed median tissue culture infectious dose (TCID50) per (/) millilitre (mL) for A/H1N1 vaccine strain and summarized for all participants who shed vaccine virus.

  • Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    Quantitation of confirmed A/H3N2 shed vaccine virus was evaluated using the log (TCID50)/mL for A/H3N2 vaccine strain and summarized for all participants who shed vaccine virus.

  • Quantitation of Confirmed B Shed Vaccine Virus on Any Day [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    Quantitation of confirmed B shed vaccine virus was evaluated using the log (TCID50)/mL for B vaccine strain and summarized for all participants who shed vaccine virus.

  • Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the cold-adapted (ca) and temperature-sensitive (ts) phenotypes. Viruses were considered ts if their titer at 39 degrees Celsius (°C) was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.

  • Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 39°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.

  • Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]
    The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 37°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes.

  • Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination [ Time Frame: Days 0-28 after vaccination (up to Day 28) ]
    REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  • Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination [ Time Frame: Days 0-180 after vaccination (up to 6.5 months) ]
    An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An SNMC is defined as a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. SNMCs included, but were not limited to, diabetes, asthma, autoimmune disease (lupus, rheumatoid arthritis), and neurological disease (epilepsy, autism).

  • Number of Participants With REs in Relation to Any Vaccine Virus Shedding [ Time Frame: Days 0-28 after study vaccination (up to Day 28) ]
    REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability.


Enrollment: 200
Actual Study Start Date: May 1, 2006
Study Completion Date: December 1, 2006
Primary Completion Date: July 1, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Biological: 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.
Other Names:
  • FluMist
  • Cold-adapted influenza virus vaccine, trivalent (CAIV-T)
  • Live attenuated influenza virus (LAIV)
Experimental: 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).
Biological: 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.
Other Names:
  • FluMist
  • Cold-adapted influenza virus vaccine, trivalent (CAIV-T)
  • Live attenuated influenza virus (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 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

Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Metairie, Louisiana, United States, 70006
United States, New York
Health Sciences Research Center
Cortland, 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
  More Information

Publications:
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: July 21, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MedImmune LLC:
children, FluMist, shedding,

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017