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

NCT03143101 | Completed Phase 4 Results FDA Drug

• 1 other identifier: D2560C00013
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 12

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.

Conditions

Influenza; Healthy

Keywords

FluMist Quadrivalent; Trivalent; Influenza; Vaccine; Prevention

Outcome Measures

Primary Outcomes (8)

• 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.

  Day 28

• 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.

  Day 28

• 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.

  Day 28

• 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.

  Day 28

• 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.

  Day 56

• 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.

  Day 56

• 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.

  Day 56

• 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.

  Day 56

Secondary Outcomes (8)

• 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)

  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)

• Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR

  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)

• Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR

  Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose)

• Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus

  Days 28 and 56

• Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56

  Days 28 and 56

Study Arms (3)

FluMist trivalent (2015-2016)

EXPERIMENTAL

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).

Biological: FluMist trivalent (2015-2016)

FluMist Quadrivalent (2015-2016)

EXPERIMENTAL

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).

Biological: FluMist Quadrivalent (2015-2016)

FluMist Quadrivalent (2017-2018)

EXPERIMENTAL

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).

Biological: FluMist Quadrivalent (2017-2018)

Interventions

FluMist trivalent (2015-2016) BIOLOGICAL

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.

FluMist trivalent (2015-2016)

FluMist Quadrivalent (2015-2016) BIOLOGICAL

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.

FluMist Quadrivalent (2015-2016)

FluMist Quadrivalent (2017-2018) BIOLOGICAL

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.

FluMist Quadrivalent (2017-2018)

Eligibility Criteria

• Age: 24 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead
• AstraZeneca: collaborator

Study Sites (12)

Research Site

Savannah, Georgia, 31405, United States

Location

Research Site

Bardstown, Kentucky, 40004, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Norfolk, Nebraska, 68701, United States

Location

Research Site

Omaha, Nebraska, 68134, United States

Location

Research Site

Binghamton, New York, 13901, United States

Location

Research Site

Dakota Dunes, South Dakota, 57049, United States

Location

Research Site

Fort Worth, Texas, 76104, United States

Location

Research Site

San Angelo, Texas, 76904, United States

Location

Research Site

Tomball, Texas, 77375, United States

Location

Research Site

Salt Lake City, Utah, 84124, United States

Location

Research Site

West Jordan, Utah, 84088, United States

Location

Related Links

• CSP in PDF-A
• Statistical Analysis Plan (SAP) in PDF-A

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Raburn Mallory
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1-301-398-5799

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: May 8, 2017
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Locations

US (12)