A Phase 4 interventional study of Trivalent 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 2014-11-10.
Sponsored by MedImmune LLC · Phase 4, Interventional, and Prevention
This prospective annual release study is designed to evaluate the safety on new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 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 trivalent 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 300 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) of trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Biological: Trivalent Influenza Vaccine
A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Other: Placebo
A single dose of 10\^(7.0 ± 0.5) FFU of trivalent influenza vaccine will be administered as intranasal spray on Day 1.
A single dose of placebo matched to trivalent 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: Within 7 days after vaccination
Percentage of Participants With Solicited Symptoms
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms included 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 are reported for all solicited symptoms except fever \>=101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.
Time frame: Within 7 and 14 days after vaccination
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was 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 14 days after vaccination that were absent before treatment or that worsened relative to pre-treatment state. Results are given for AEs reported within 7 days and 14 days after vaccination.
Time frame: Within 7 and 14 days after vaccination
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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 180 days after the dose that were absent before treatment or that worsen relative to pretreatment state. An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Results are given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.
Time frame: Within 28 and 180 days after vaccination
Percentage of Participants Who Required Antipyretic and/or Analgesic Medication
Time frame: Within 7 and 14 days after vaccination
| Milestone | Trivalent Influenza Vaccine | Placebo |
|---|---|---|
| Started | 240 | 60 |
| Completed | 238 | 60 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
| percentage of participants | Trivalent Influenza Vaccine | Placebo |
|---|---|---|
| Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) | 0.4 | 0.0 |
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms included 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 are reported for all solicited symptoms except fever \>=101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.
| percentage of participants | Trivalent Influenza Vaccine | Placebo |
|---|---|---|
| Any symptom within 7 days | 37.3 | 25.4 |
| Fever: greater than 100 degrees F within 7 days | 0.8 | 0.0 |
| Fever: greater than 102 degrees F within 7 days | 0.0 | 0.0 |
| Fever: greater than 103 degrees F within 7 days | 0.0 | 0.0 |
| Runny nose within 7 days | 20.7 | 11.9 |
| Sore throat within 7 days | 9.5 | 3.4 |
| Cough within 7 days | 4.6 | 5.1 |
| Vomiting within 7 days | 0.0 | 0.0 |
| Muscle aches within 7 days | 3.3 | 3.4 |
| Chills within 7 days | 1.7 | 0.0 |
| Decreased activity (tiredness) within 7 days | 10.0 | 6.8 |
| Headache within 7 days | 15.4 | 11.9 |
| Any symptom within 14 days | 39.4 | 27.1 |
| Fever: greater than 100 degrees F within 14 days | 1.2 | 0.0 |
| Fever: >= 101 degrees F within 14 days | 0.8 | 0.0 |
| Fever: greater than 102 degrees F within 14 days | 0.0 | 0.0 |
| Fever: greater than 103 degrees F within 14 days | 0.0 | 0.0 |
| Runny nose within 14 days | 21.6 | 11.9 |
| Sore throat within 14 days | 11.2 | 6.8 |
| Cough within 14 days | 5.4 | 5.1 |
| Vomiting within 14 days | 0.4 | 0.0 |
| Muscle aches within 14 days | 3.7 | 3.4 |
| Chills within 14 days | 2.5 | 0.0 |
| Decreased activity (tiredness) within 14 days | 11.2 | 6.8 |
| Headache within 14 days | 16.6 | 13.6 |
An adverse event (AE) was 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 14 days after vaccination that were absent before treatment or that worsened relative to pre-treatment state. Results are given for AEs reported within 7 days and 14 days after vaccination.
| participants | Trivalent Influenza Vaccine | Placebo |
|---|---|---|
| Within 7 days | 26 | 4 |
| Within 14 days | 28 | 5 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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 180 days after the dose that were absent before treatment or that worsen relative to pretreatment state. An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Results are given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.
| participants | Trivalent Influenza Vaccine | Placebo |
|---|---|---|
| TESAEs within 28 days | 1 | 0 |
| TESAEs within 180 days | 1 | 2 |
| NOCDs within 28 days | 0 | 0 |
| NOCDs within 180 days | 0 | 0 |
| percentage of participants | Trivalent Influenza Vaccine | Placebo |
|---|---|---|
| Anti-pyretic or analgesic within 7 days | 9.1 | 5.1 |
| Anti-pyretic and analgesic within 7 days | 8.7 | 5.1 |
| Anti-pyretic or analgesic within 14 days | 9.1 | 6.8 |
| Anti-pyretic and analgesic within 14 days | 8.7 | 6.8 |
Collected over Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TRIVALENT VACCINE | — | 1/241 (0.4%) | 28/241 (11.6%) |
| PLACEBO | — | 2/59 (3.4%) | 5/59 (8.5%) |
| Event | TRIVALENT VACCINE | PLACEBO |
|---|---|---|
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/241 | 1/59 |
| MenorrhagiaReproductive system and breast disorders | 0/241 | 1/59 |
| Non-cardiac chest painGeneral disorders | 1/241 | 0/59 |
| Event | TRIVALENT VACCINE | PLACEBO |
|---|---|---|
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 16/241 | 3/59 |
| LymphadenopathyBlood and lymphatic system disorders | 0/241 | 1/59 |
| DiarrhoeaGastrointestinal disorders | 1/241 | 1/59 |
| NauseaGastrointestinal disorders | 3/241 | 1/59 |
| Nasal discharge discolourationRespiratory, thoracic and mediastinal disorders | 0/241 | 1/59 |
| Night sweatsSkin and subcutaneous tissue disorders | 1/241 | 1/59 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 4/241 | 0/59 |
| SneezingRespiratory, thoracic and mediastinal disorders | 3/241 | 0/59 |
| Upper respiratory tract infectionInfections and infestations | 2/241 | 0/59 |
| DyspepsiaGastrointestinal disorders | 1/241 | 0/59 |
Analysis population included all randomized participants.
| Age, Continuous(years) | Trivalent Influenza Vaccine | Placebo | Total |
|---|---|---|---|
| Mean | 33.1 ± 9.4 | 33.6 ± 9.0 | 33.2 ± 9.3 |
| Sex: Female, Male(Participants) | Trivalent Influenza Vaccine | Placebo | Total |
|---|---|---|---|
| Female | 137 | 34 | 171 |
| Male | 103 | 26 | 129 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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