HealthyPhase 2NCT00344305
A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
A Phase 2 study testing Trivalent influenza virus vaccine live, intranasal in people with Healthy, run by MedImmune LLC at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Trivalent influenza virus vaccine live, intranasal
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 May 2006to 1 Dec 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, 40004
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015
Health Sciences Research Center
Cortland, New York, 13045
Health Sciences Research Center
Elmira, New York, 14901
Regional Clinical Research Inc.
Endwell, New York, 13760
Med-Pro Research Inc.
Houston, Texas, 77004
Wee Care Pediatrics
Layton, Utah, 84041
Little Rock Allergy & Asthma Clinic, PA
Little Rock, Arkansas, 72205
Pediatric and Adolescent Medicine, PA (PAMPA)
Marietta, Georgia, 30062
Benchmark Research
Metairie, Louisiana, 70006
Central Texas Health Research
New Braunfels, Texas, 78130
Grand Prairie Pediatrics & Allergy Clinic
Oklahoma City, Oklahoma, 73132
Primary Physicians Research , Inc
Pittsburgh, Pennsylvania, 15241
Utah Valley Pediatrics
Provo, Utah, 84604
Benchmark Research
San Angelo, Texas, 76904
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
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
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.
Read the 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
- Being tested
- Trivalent influenza virus vaccine live, intranasal
- Keywords
- children, FluMist, shedding,
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent influenza virus vaccine live, intranasalBiological
Also called FluMist, Cold-adapted influenza virus vaccine, trivalent (CAIV-T), Live attenuated influenza virus (LAIV)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: Trivalent influenza virus vaccine live, intranasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1-28 after study vaccination (up to Day 28)
Secondary outcomes (13)
Duration of Any Vaccine Virus Shedding
The number of days of shedding was summarized for all participants who shed any vaccine virus.
Measured: Days 1-28 after study vaccination (up to Day 28)
Duration of Confirmed A/H1N1 Vaccine Virus Shedding
The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus.
Measured: Days 1-28 after study vaccination (up to Day 28)
Duration of Confirmed A/H3N2 Vaccine Virus Shedding
The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus.
Measured: Days 1-28 after study vaccination (up to Day 28)
Duration of Confirmed B Vaccine Virus Shedding
The number of days of shedding was summarized for all participants who shed confirmed B strain virus.
Measured: Days 1-28 after study vaccination (up to Day 28)
Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
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.
Measured: Days 1-28 after study vaccination (up to Day 28)
Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
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.
Measured: Days 1-28 after study vaccination (up to Day 28)
Quantitation of Confirmed B Shed Vaccine Virus on Any Day
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.
Measured: Days 1-28 after study vaccination (up to Day 28)
Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
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.
Measured: Days 1-28 after study vaccination (up to Day 28)
Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
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.
Measured: Days 1-28 after study vaccination (up to Day 28)
Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
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.
Measured: 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
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.
Measured: 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
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).
Measured: Days 0-180 after vaccination (up to 6.5 months)
Number of Participants With REs in Relation to Any Vaccine Virus Shedding
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.
Measured: Days 0-28 after study vaccination (up to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study start1 May 2006
- Primary completion1 Jul 2006
- Study completion1 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raburn Mallory, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344305
- Sponsor's protocol ID
- MI-CP129
- Status last verified
- Jul 2017
- First submitted
- 22 Jun 2006
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 21513761
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00344305
- Acronym / sponsor ID
- MI-CP129
- Conditions
- Healthy
- Keywords
- children, FluMist, shedding,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2006 (actual)
- Primary completion
- 1 Jul 2006 (actual)
- Study completion
- 1 Dec 2006 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Posted 1 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Participants Between 6 to < 24 Months Age | Experimental | Biological: Trivalent influenza virus vaccine live, intranasalParticipants 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). |
| Cohort 2: Participants Between 24 to < 60 Months Age | Experimental | Biological: Trivalent influenza virus vaccine live, intranasalParticipants 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). |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent influenza virus vaccine live, intranasalAlso: FluMist, Cold-adapted influenza virus vaccine, trivalent (CAIV-T), Live attenuated influenza virus (LAIV)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. | Biological | Cohort 1: Participants Between 6 to < 24 Months Age, Cohort 2: Participants Between 24 to < 60 Months Age |
Primary outcome
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.
13 secondary outcomes
Duration of Any Vaccine Virus Shedding
Time frame: Days 1-28 after study vaccination (up to Day 28)
Duration of Confirmed A/H1N1 Vaccine Virus Shedding
Time frame: Days 1-28 after study vaccination (up to Day 28)
Duration of Confirmed A/H3N2 Vaccine Virus Shedding
Time frame: Days 1-28 after study vaccination (up to Day 28)
Duration of Confirmed B Vaccine Virus Shedding
Time frame: Days 1-28 after study vaccination (up to Day 28)
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/H3N2 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 on Any Day
Time frame: Days 1-28 after study vaccination (up to Day 28)
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)
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)
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)
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)
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)
Number of Participants With REs in Relation to Any Vaccine Virus Shedding
Time frame: Days 0-28 after study vaccination (up to Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21513761Mallory 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raburn Mallory, M.D. study director
MedImmune LLC
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trivalent influenza virus vaccine live, intranasal in people with Healthy, run by MedImmune LLC at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Shed Any Vaccine Virus (time frame: Days 1-28 after study vaccination (up to Day 28)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.