A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
21. Juli 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
200
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Arkansas
-
Little Rock, Arkansas, Vereinigte Staaten, 72205
- Little Rock Allergy & Asthma Clinic, PA
-
-
Georgia
-
Marietta, Georgia, Vereinigte Staaten, 30062
- Pediatric and Adolescent Medicine, PA (PAMPA)
-
-
Kentucky
-
Bardstown, Kentucky, Vereinigte Staaten, 40004
- Kentucky Pediatrics/Adult Research
-
-
Louisiana
-
Metairie, Louisiana, Vereinigte Staaten, 70006
- Benchmark Research
-
-
New York
-
Cortland, New York, Vereinigte Staaten, 13045
- Health Sciences Research Center
-
Elmira, New York, Vereinigte Staaten, 14901
- Health Sciences Research Center
-
Endwell, New York, Vereinigte Staaten, 13760
- Regional Clinical Research Inc.
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Vereinigte Staaten, 73132
- Grand Prairie Pediatrics & Allergy Clinic
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15241
- Primary Physicians Research , Inc
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77004
- Med-Pro Research Inc.
-
New Braunfels, Texas, Vereinigte Staaten, 78130
- Central Texas Health Research
-
San Angelo, Texas, Vereinigte Staaten, 76904
- Benchmark Research
-
-
Utah
-
Layton, Utah, Vereinigte Staaten, 84041
- Wee Care Pediatrics
-
Provo, Utah, Vereinigte Staaten, 84604
- Utah Valley Pediatrics
-
-
Virginia
-
Burke, Virginia, Vereinigte Staaten, 22015
- PI-Coor Clinical Research, LLC
-
Vienna, Virginia, Vereinigte Staaten, 22180
- Advanced Pediatrics
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
6 Monate bis 4 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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).
|
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.
Andere Namen:
|
|
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).
|
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants Who Shed Any Vaccine Virus
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Percentage of Participants Who Shed A/H1N1 Vaccine Virus
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Percentage of Participants Who Shed A/H3N2 Vaccine Virus
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Percentage of Participants Who Shed B Vaccine Virus
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Duration of Any Vaccine Virus Shedding
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Duration of Confirmed A/H1N1 Vaccine Virus Shedding
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Duration of Confirmed A/H3N2 Vaccine Virus Shedding
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Duration of Confirmed B Vaccine Virus Shedding
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Quantitation of Confirmed B Shed Vaccine Virus on Any Day
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
Zeitfenster: 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.
|
Days 1-28 after study vaccination (up to Day 28)
|
|
Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
Zeitfenster: 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.
|
Days 0-28 after vaccination (up to Day 28)
|
|
Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
Zeitfenster: 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).
|
Days 0-180 after vaccination (up to 6.5 months)
|
|
Number of Participants With REs in Relation to Any Vaccine Virus Shedding
Zeitfenster: 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.
|
Days 0-28 after study vaccination (up to Day 28)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Raburn Mallory, M.D., MedImmune LLC
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2006
Primärer Abschluss (Tatsächlich)
1. Juli 2006
Studienabschluss (Tatsächlich)
1. Dezember 2006
Studienanmeldedaten
Zuerst eingereicht
22. Juni 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Juni 2006
Zuerst gepostet (Schätzen)
26. Juni 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. Juli 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Juli 2017
Zuletzt verifiziert
1. Juli 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MI-CP129
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .