A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
2017년 7월 21일 업데이트: MedImmune LLC
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
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
200
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Little Rock Allergy & Asthma Clinic, PA
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Georgia
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Marietta, Georgia, 미국, 30062
- Pediatric and Adolescent Medicine, PA (PAMPA)
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Kentucky
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Bardstown, Kentucky, 미국, 40004
- Kentucky Pediatrics/Adult Research
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Louisiana
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Metairie, Louisiana, 미국, 70006
- Benchmark Research
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New York
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Cortland, New York, 미국, 13045
- Health Sciences Research Center
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Elmira, New York, 미국, 14901
- Health Sciences Research Center
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Endwell, New York, 미국, 13760
- Regional Clinical Research Inc.
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73132
- Grand Prairie Pediatrics & Allergy Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15241
- Primary Physicians Research , Inc
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Texas
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Houston, Texas, 미국, 77004
- Med-Pro Research Inc.
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New Braunfels, Texas, 미국, 78130
- Central Texas Health Research
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San Angelo, Texas, 미국, 76904
- Benchmark Research
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Utah
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Layton, Utah, 미국, 84041
- Wee Care Pediatrics
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Provo, Utah, 미국, 84604
- Utah Valley Pediatrics
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Virginia
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Burke, Virginia, 미국, 22015
- PI-Coor Clinical Research, LLC
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Vienna, Virginia, 미국, 22180
- Advanced Pediatrics
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6개월 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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).
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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.
다른 이름들:
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실험적: 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).
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Who Shed Any Vaccine Virus
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Percentage of Participants Who Shed A/H1N1 Vaccine Virus
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Percentage of Participants Who Shed A/H3N2 Vaccine Virus
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Percentage of Participants Who Shed B Vaccine Virus
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Duration of Any Vaccine Virus Shedding
기간: Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed any vaccine virus.
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Days 1-28 after study vaccination (up to Day 28)
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Duration of Confirmed A/H1N1 Vaccine Virus Shedding
기간: Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.
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Days 1-28 after study vaccination (up to Day 28)
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Duration of Confirmed A/H3N2 Vaccine Virus Shedding
기간: Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.
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Days 1-28 after study vaccination (up to Day 28)
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Duration of Confirmed B Vaccine Virus Shedding
기간: Days 1-28 after study vaccination (up to Day 28)
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The number of days of shedding was summarized for all participants who shed confirmed B strain virus.
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Days 1-28 after study vaccination (up to Day 28)
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Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Quantitation of Confirmed B Shed Vaccine Virus on Any Day
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
기간: Days 1-28 after study vaccination (up to Day 28)
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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.
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Days 1-28 after study vaccination (up to Day 28)
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Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
기간: Days 0-28 after vaccination (up to Day 28)
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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.
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Days 0-28 after vaccination (up to Day 28)
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Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
기간: Days 0-180 after vaccination (up to 6.5 months)
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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).
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Days 0-180 after vaccination (up to 6.5 months)
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Number of Participants With REs in Relation to Any Vaccine Virus Shedding
기간: Days 0-28 after study vaccination (up to Day 28)
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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.
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Days 0-28 after study vaccination (up to Day 28)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Raburn Mallory, M.D., MedImmune LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2006년 5월 1일
기본 완료 (실제)
2006년 7월 1일
연구 완료 (실제)
2006년 12월 1일
연구 등록 날짜
최초 제출
2006년 6월 22일
QC 기준을 충족하는 최초 제출
2006년 6월 22일
처음 게시됨 (추정)
2006년 6월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 7월 21일
마지막으로 확인됨
2017년 7월 1일
추가 정보
이 연구와 관련된 용어
약물 및 장치 정보, 연구 문서
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예
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .