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Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age (FluMist)

Primary Purpose

Influenza, Healthy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FluMist trivalent (2015-2016)
FluMist Quadrivalent (2015-2016)
FluMist Quadrivalent (2017-2018)
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring FluMist Quadrivalent, Trivalent, Influenza, Vaccine, Prevention

Eligibility Criteria

24 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • Age 24 months to < 48 months of age
  • Healthy by medical history and physical examination or presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year

Key Exclusion Criteria:

  • History of allergic disease or reactions likely to be exacerbated by any component of the investigational product
  • Acute illness or evidence of significant active infection (including fever >= 100.4 degrees Fahrenheit (38.0 degrees Celsius) at randomization
  • History of asthma or history of recurrent wheezing
  • Any known immunosuppressive condition or immune deficiency disease
  • Current or expected receipt of immunosuppressive medications within a 28 day window around vaccination
  • Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt thru 28 days after vaccination
  • Use of antiviral agents with activity against influenza viruses within 48 hours prior to first dose of investigational product or anticipated use of such agents through the end of the study follow-up period
  • Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or planned receipt of non-study seasonal influenza vaccine prior to 28 days after last vaccination
  • Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
  • Known or suspected mitochondrial encephalomyopathy
  • History of Guillian-Barre syndrome
  • Administration of intranasal medications within 10 days prior to randomization, for expected receipt through 10 days after administration of each dose of investigational product

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

FluMist trivalent (2015-2016)

FluMist Quadrivalent (2015-2016)

FluMist Quadrivalent (2017-2018)

Arm Description

Participants will receive intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).

Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

Outcomes

Primary Outcome Measures

Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28
Seroconversion rate is defined as at least (>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28
Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 28 is reported.
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 28 is reported.
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Victoria HAI antibody titer at Day 28 is reported.
Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56
Seroconversion rate is defined as >= 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 56 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56
Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 56 is reported.
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 56 is reported.
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Victoria HAI antibody titer at Day 56 is reported.

Secondary Outcome Measures

Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)
Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Percentage of participants who shed virus are reported.
Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR
Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Number of days of virus shedding are reported.
Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR
Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral titer from the nasopharyngeal swabs. Viral titers are reported.
Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus
Seroconversion rate is defined as >= 4-fold rise from baseline in strain specific microneutralizing antibody titer. Baseline microneutralization values of less than or equal to (<=) 10 were considered as microneutralization status negative and values greater than (>) 10 were considered microneutralization positive. Percentage of participants with >= 4-fold rise in strain specific neutralizing antibody titer at Days 28 and 56 are reported.
Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56
Seroconversion rate is defined as >= 2-fold rise from baseline in strain speciific nasal IgA antibody titer. Percentage of participants with >= 2-fold rise in strain speciific nasal IgA antibody titer at Days 28 and 56 are reported for this outcome.
Percentage of Participants With Any Post Dose Strain-specific Antibody Response
Strain specific antibody response defined as >= 4-fold increase in HAI antibodies or >= 4-fold increase in neutralizing antibodies or >= 2-fold increase in IgA antibodies.
Percentage of Participants With Any Solicited Symptoms
Solicited symptoms included fever by any route (temperature >= 100.4 degrees Fahrenheit), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, lethargy or tiredness/weakness, and decreased appetite.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug.

Full Information

First Posted
May 4, 2017
Last Updated
November 16, 2018
Sponsor
MedImmune LLC
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03143101
Brief Title
Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age
Acronym
FluMist
Official Title
A Phase 4 Double-blind Study to Evaluate the Shedding and Immunogenicity of Trivalent and Quadrivalent Formulations of FluMist in Children 24 to < 48 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.
Detailed Description
This randomized, double-blind, multi-center study will enroll approximately 200 children 24 to less than (<) 48 months of age. Participants will be randomized in a 1:1:1 ratio to receive two doses of either FluMist quadrivalent 2017-2018, FluMist quadrivalent 2015-2016 formulation, or FluMist trivalent 2015-2016 formulation. Participants will be screened within 30 days prior to randomization. Randomization will be stratified according to whether the participant ever received prior influenza vaccination. Approximately 50% of the participants will not have been previously vaccinated. All participants will receive two doses of investigational product on Study Days 1 and 28, and followed for a 28-day follow-up period after each dose. Blood and nasal samples will be collected and safety evaluations perfomed. The duration of participants participation is approximately 2 to 3 months. The study will be conducted during the influenza "off-season" in the US. After completion of the study all participants will be offered and strongly encouraged to receive an inactivated influenza vaccine approved for use in the US for the 2017-2018 influenza season.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Healthy
Keywords
FluMist Quadrivalent, Trivalent, Influenza, Vaccine, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FluMist trivalent (2015-2016)
Arm Type
Experimental
Arm Description
Participants will receive intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
Arm Title
FluMist Quadrivalent (2015-2016)
Arm Type
Experimental
Arm Description
Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
Arm Title
FluMist Quadrivalent (2017-2018)
Arm Type
Experimental
Arm Description
Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
Intervention Type
Biological
Intervention Name(s)
FluMist trivalent (2015-2016)
Intervention Description
0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
Intervention Type
Biological
Intervention Name(s)
FluMist Quadrivalent (2015-2016)
Intervention Description
0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
Intervention Type
Biological
Intervention Name(s)
FluMist Quadrivalent (2017-2018)
Intervention Description
0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
Primary Outcome Measure Information:
Title
Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28
Description
Seroconversion rate is defined as at least (>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Time Frame
Day 28
Title
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 28 is reported.
Time Frame
Day 28
Title
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 28 is reported.
Time Frame
Day 28
Title
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Victoria HAI antibody titer at Day 28 is reported.
Time Frame
Day 28
Title
Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 56 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Time Frame
Day 56
Title
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 56 is reported.
Time Frame
Day 56
Title
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 56 is reported.
Time Frame
Day 56
Title
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Victoria HAI antibody titer at Day 56 is reported.
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)
Description
Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Percentage of participants who shed virus are reported.
Time Frame
Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4, and 6 after Dose 2 (Day 28 dose)
Title
Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR
Description
Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Number of days of virus shedding are reported.
Time Frame
Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4 and 6 after Dose 2 (Day 28 dose)
Title
Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR
Description
Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral titer from the nasopharyngeal swabs. Viral titers are reported.
Time Frame
Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose)
Title
Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus
Description
Seroconversion rate is defined as >= 4-fold rise from baseline in strain specific microneutralizing antibody titer. Baseline microneutralization values of less than or equal to (<=) 10 were considered as microneutralization status negative and values greater than (>) 10 were considered microneutralization positive. Percentage of participants with >= 4-fold rise in strain specific neutralizing antibody titer at Days 28 and 56 are reported.
Time Frame
Days 28 and 56
Title
Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56
Description
Seroconversion rate is defined as >= 2-fold rise from baseline in strain speciific nasal IgA antibody titer. Percentage of participants with >= 2-fold rise in strain speciific nasal IgA antibody titer at Days 28 and 56 are reported for this outcome.
Time Frame
Days 28 and 56
Title
Percentage of Participants With Any Post Dose Strain-specific Antibody Response
Description
Strain specific antibody response defined as >= 4-fold increase in HAI antibodies or >= 4-fold increase in neutralizing antibodies or >= 2-fold increase in IgA antibodies.
Time Frame
Days 28 and 56
Title
Percentage of Participants With Any Solicited Symptoms
Description
Solicited symptoms included fever by any route (temperature >= 100.4 degrees Fahrenheit), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, lethargy or tiredness/weakness, and decreased appetite.
Time Frame
Day 1 through Day 14 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug.
Time Frame
Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Age 24 months to < 48 months of age Healthy by medical history and physical examination or presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year Key Exclusion Criteria: History of allergic disease or reactions likely to be exacerbated by any component of the investigational product Acute illness or evidence of significant active infection (including fever >= 100.4 degrees Fahrenheit (38.0 degrees Celsius) at randomization History of asthma or history of recurrent wheezing Any known immunosuppressive condition or immune deficiency disease Current or expected receipt of immunosuppressive medications within a 28 day window around vaccination Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt thru 28 days after vaccination Use of antiviral agents with activity against influenza viruses within 48 hours prior to first dose of investigational product or anticipated use of such agents through the end of the study follow-up period Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or planned receipt of non-study seasonal influenza vaccine prior to 28 days after last vaccination Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation Known or suspected mitochondrial encephalomyopathy History of Guillian-Barre syndrome Administration of intranasal medications within 10 days prior to randomization, for expected receipt through 10 days after administration of each dose of investigational product
Facility Information:
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Research Site
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Site
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Research Site
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Research Site
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Research Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Research Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14608&filename=D2560C00013-clinical-study-protocol-v2-CA_redaction_18SEP18_(RM)_Redacted_PDF-A.pdf
Description
CSP in PDF-A
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14608&filename=D2560C00013_Statistical_Analysis_Plan_Final_V1.0_PDF-A.pdf
Description
Statistical Analysis Plan (SAP) in PDF-A

Learn more about this trial

Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age

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