A Phase 4 interventional study of Monovalent Influenza Vaccine and Placebo in Influenza and Healthy, sponsored by MedImmune LLC. Completed at 3 sites in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-04.
Sponsored by MedImmune LLC · Phase 4, Interventional, and Prevention
This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2016-2017 influenza season
This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 3 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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 301 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.
Biological: Monovalent Influenza Vaccine
A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.
Other: Placebo
A single dose of 10\^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.
A single dose of placebo matched to 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)
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
Time frame: Baseline (Day 1) up to Day 8
Percentage of Participants With Solicited Symptoms
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.
Time frame: Baseline (Day 1) up to Day 8 and Day 15
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: Baseline (Day 1) up to Day 8 and Day 15
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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.
Time frame: Baseline (Day 1) up to Day 29 and Day 181
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication
Percentage of participants who require antipyretic and/or analgesic medication were reported.
Time frame: Baseline (Day 1) up to Day 8 and Day 15
A total of 301 participants were randomized and participated in the study from 02-May-2016 through 30-Nov-2016 at 3 sites in the United States of America (USA).
| Milestone | Placebo | Monovalent Influenza Vaccine |
|---|---|---|
| Started | 60 | 241 |
| Treated | 59 | 241 |
| Completed | 59 | 240 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Other | 1 | 0 |
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
| Percentage of participants | Placebo | Monovalent Influenza Vaccine |
|---|---|---|
| Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) | 1.7 | 0.4 |
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.
| Percentage of participants | Placebo | Monovalent Influenza Vaccine |
|---|---|---|
| Up to Day 8 | 33.9 | 25.7 |
| Up to Day 15 | 37.3 | 29.9 |
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.
| Participants | Placebo | Monovalent Influenza Vaccine |
|---|---|---|
| Up to Day 8 | 1 | 9 |
| Up to Day 15 | 1 | 14 |
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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.
| Participants | Placebo | Monovalent Influenza Vaccine |
|---|---|---|
| Up to Day 29: TESAEs | 0 | 0 |
| Up to Day 29: NOCDs | 0 | 0 |
| Up to Day 181: TESAEs | 0 | 0 |
| Up to Day 181: NOCDs | 0 | 0 |
Percentage of participants who require antipyretic and/or analgesic medication were reported.
| Percentage of participants | Placebo | Monovalent Influenza Vaccine |
|---|---|---|
| Up to Day 8 | 3.4 | 1.2 |
| Up to Day 15 | 5.1 | 1.7 |
Collected over Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/59 (0%) | 1/59 (1.7%) |
| Monovalent Influenza Vaccine | — | 0/241 (0%) | 14/241 (5.8%) |
| Event | Placebo | Monovalent Influenza Vaccine |
|---|---|---|
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/59 | 5/241 |
| PyrexiaGeneral disorders | 1/59 | 1/241 |
| NauseaGastrointestinal disorders | 0/59 | 3/241 |
| SneezingRespiratory, thoracic and mediastinal disorders | 0/59 | 2/241 |
| DiarrhoeaGastrointestinal disorders | 0/59 | 1/241 |
| Food poisoningGastrointestinal disorders | 0/59 | 1/241 |
| LaryngitisInfections and infestations | 0/59 | 1/241 |
| PharyngitisInfections and infestations | 0/59 | 1/241 |
| DysgeusiaNervous system disorders | 0/59 | 1/241 |
The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.
| Age, Continuous(Years) | Placebo | Monovalent Influenza Vaccine | Total |
|---|---|---|---|
| Mean | 33.2 ± 9.4 | 33.3 ± 9.5 | 33.3 ± 9.4 |
| Sex: Female, Male(Participants) | Placebo | Monovalent Influenza Vaccine | Total |
|---|---|---|---|
| Female | 33 | 139 | 172 |
| Male | 26 | 102 | 128 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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