Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season (FluMist)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03158038|
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Influenza Healthy||Biological: Monovalent Influenza Vaccine Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults|
|Actual Study Start Date :||May 30, 2017|
|Actual Primary Completion Date :||December 14, 2017|
|Actual Study Completion Date :||December 14, 2017|
Experimental: Monovalent Influenza Vaccine
Participants will receive a single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain] by intranasal spray on Day 1.
Biological: Monovalent Influenza Vaccine
A single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain] will be administered as intranasal spray on Day 1.
Placebo Comparator: Placebo
Participants will receive a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.
- Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) [ Time Frame: Baseline (Day 1) up to Day 8 ]Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.
- Percentage of Participants With Solicited Symptoms [ Time Frame: Baseline (Day 1) up to Day 8 and Day 15 ]Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline (Day 1) up to 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. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination.
- Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) [ Time Frame: Baseline (Day 1) up to Day 29 and Day 181 ]An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination.
- Percentage of Participants Who Require Antipyretic and/or Analgesic Medication [ Time Frame: Baseline (Day 1) up to Day 8 and Day 15 ]Percentage of participants who require antipyretic and/or analgesic medication were reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158038
|United States, Georgia|
|Stockbridge, Georgia, United States, 30281|
|United States, Oregon|
|Portland, Oregon, United States, 97239|