D2560C00015 FluMist Annual Safety Study 2018

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bivalent influenza vaccine

Placebo

About this trial

This is an interventional prevention trial for Influenza focused on measuring Bivalent., Influenza., FluMist Quadrivalent., Vaccine Prevention in Healthy Adults.

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 18 through 49 years
Written informed consent
Subject available by telephone
Ability to understand and comply with the requirements of the protocol, as judged by the Investigator

Exclusion Criteria:

Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example (eg], asthma), chronic metabolic diseases (eg, diabetes mellitus), renaldysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
Acute febrile (greater than [>]100.0 degrees Fahrenheit [F] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days to randomization
Any known immunosuppressive condition or immune deficiency diseases, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
History of Guillain-Barre syndrome.

Sites / Locations

Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bivalent influenza vaccine

Placebo

Arm Description

A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1

A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.

Outcomes

Primary Outcome Measures

Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8

Percentage of participants with fever (oral temperature >= 101 degrees Fahrenheit) through Day 8 is reported.

Secondary Outcome Measures

Number of Participants With Solicited Symptoms Through Day 8

For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.

Number of Participants With Solicited Symptoms Through Day 15

For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181

An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.

Full Information

NCT ID

NCT03564444

First Posted

June 11, 2018

Last Updated

December 10, 2019

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT03564444

Brief Title

D2560C00015 FluMist Annual Safety Study 2018

Official Title

A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

June 6, 2018 (Actual)

Primary Completion Date

December 27, 2018 (Actual)

Study Completion Date

December 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedImmune LLC

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 prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.

Detailed Description

This prospective. randomized, double-blind. placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday). Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 2 sites in the United States of America. Each subject will receive 1 dose of investigational product on Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Healthy

Keywords

Bivalent., Influenza., FluMist Quadrivalent., Vaccine Prevention in Healthy Adults.

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bivalent influenza vaccine

Arm Type

Experimental

Arm Description

A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.

Intervention Type

Biological

Intervention Name(s)

Bivalent influenza vaccine

Intervention Description

A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.

Primary Outcome Measure Information:

Title

Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8

Description

Percentage of participants with fever (oral temperature >= 101 degrees Fahrenheit) through Day 8 is reported.

Time Frame

Day 1 through Day 8

Secondary Outcome Measure Information:

Title

Number of Participants With Solicited Symptoms Through Day 8

Description

For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.

Time Frame

Day 1 through Day 8

Title

Number of Participants With Solicited Symptoms Through Day 15

Description

For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.

Time Frame

Day 1 through Day 15

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15

Description

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events 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 8; Day 1 through Day 15

Title

Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181

Description

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is 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. The TEAEs are defined as events 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 29; Day 1 through Day 181

Title

Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181

Description

An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.

Time Frame

Day 1 through Day 29; Day 1 through Day 181

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 through 49 years Written informed consent Subject available by telephone Ability to understand and comply with the requirements of the protocol, as judged by the Investigator Exclusion Criteria: Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181) History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example (eg], asthma), chronic metabolic diseases (eg, diabetes mellitus), renaldysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year Acute febrile (greater than [>]100.0 degrees Fahrenheit [F] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days to randomization Any known immunosuppressive condition or immune deficiency diseases, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy History of Guillain-Barre syndrome.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathan Segall, MD

Organizational Affiliation

Clinical Research Atlanta

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Keith Klatt, MD

Organizational Affiliation

Columbia Research Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D2560C00015&attachmentIdentifier=8e50bdf3-f051-45ee-a9e9-e40b1d25de6c&fileName=d2560c00015-csp-v1_Redacted.pdf&versionIdentifier=

Description

Protocol and Statistical Analysis Plan (SAP)

Influenza, Healthy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial