Influenza
Conditions
Keywords
Trivalent, Influenza, FluMist, Vaccine, Prevention
Brief summary
This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.
Detailed description
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 one dose of investigational product on Study Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.
Interventions
BIOLOGICALTrivalent Influenza Virus Vaccine
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
OTHERPlacebo
Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
Sponsors
AstraZeneca
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 through 49 years at the time of investigational product administration 2. Written informed consent and any locally required authorization (ie, HIPAA in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations 3. Females of childbearing potential who are sexually active with a nonsterilized male partner must use effective contraception for 30 days prior to study vaccination, and must agree to continue using such precautions for 60 days after study vaccination 4. Nonsterilized males who are sexually active with a female partner of child-bearing potential must use an effective method of contraception from prior to study vaccination amd must agree to continue using such precautions for at least 30 days after receipt study vaccination 5. Healthy by medical history and physical examination 6. Female subjects of child-bearing potential must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization. 7. Subject available by telephone 8. Ability to understand and comply with the requirements of the protocol, as judged by the investigator 9. Ability to complete follow-up period of 180 days after dosing as required by the protocol
Exclusion criteria
1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results 2. Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181) 3. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals 4. 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 5. History of hypersensitivity to gentamicin 6. Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year 7. Acute febrile (\> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization 8. Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy 9. History of Guillain-Barré syndrome 10. A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); additionally, subject should avoid close contact with severely immunocompromised individuals for at least 21 days after study vaccination 11. Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted) 12. Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after study vaccination 13. Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination 14. Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination 15. Receipt of influenza antiviral therapy or antiviral agents within 48 hours prior to study vaccination or expected receipt of influenza antiviral therapy or antiviral agents through 14 days after study vaccination 16. Known or suspected mitochondrial encephalomyopathy 17. Nursing mother
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Fever Within 7 Days Post Vaccination | Study Days 1 - 8 | A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination | Study Days 1 - 8 | Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1. |
| Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Study Days 1 - 15 | Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below. |
| Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination | Study Days 1 - 15 | Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1. |
| Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination | Study Days 1 - 29 | Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1. |
| Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Study Days 1- 8 | Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below. |
| Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination | Study Days 1 - 29 | An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1. |
| Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination | Study Days 1 - 181 | An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1. |
| Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination | Study Days 1 - 8 | Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1. |
| Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination | Study Days 1 - 15 | Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1. |
| Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination | Study Days 1 - 181 | Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1. |
Countries
United States
Participant flow
Recruitment details
303 participants participated in the study from 21May2012 (date of first written informed consent) through 30Nov2012 (date of last participant visit).
Pre-assignment details
Eligible participants were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site.
Participants by arm
| Arm | Count |
|---|---|
| Trivalent Influenza Virus Vaccine Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1. | 242 |
| Placebo Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1. | 61 |
| TOTAL Total of all reporting groups | 303 |
| Total | 606 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Trivalent Influenza Virus Vaccine | Placebo | TOTAL |
|---|---|---|---|
| Age, Continuous | 32.7 Years STANDARD_DEVIATION 9.1 | 32.0 Years STANDARD_DEVIATION 8.8 | 32.6 Years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 136 Participants | 29 Participants | 165 Participants |
| Sex: Female, Male Male | 106 Participants | 32 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 241 | 4 / 60 |
| serious Total, serious adverse events | 1 / 241 | 1 / 60 |
Outcome results
Primary
Percentage of Participants Reporting Fever Within 7 Days Post Vaccination
A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.
Time frame: Study Days 1 - 8
Population: All participants who received a single dose of investigational product (trivalent influenza vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Fever Within 7 Days Post Vaccination | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Fever Within 7 Days Post Vaccination | 1.7 Percentage of Participants |
Comparison: Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (trivalent influenza virus vaccine minus placebo) evaluated against the prespecified equivalence criterion of 5 percentage points95% CI: [-8.9, 0.6]Score statistic
Secondary
Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination
Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 15
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination | 7.9 Percentage of participants |
| Placebo | Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination | 6.7 Percentage of participants |
Secondary
Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination
Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 8
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination | 7.5 Percentage of participants |
| Placebo | Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination | 6.7 Percentage of participants |
Secondary
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 181
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination | 0.4 Percentage of participants |
| Placebo | Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination | 0.0 Percentage of participants |
Secondary
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 29
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination | 0.0 Percentage of participants |
Secondary
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination
Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 181
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination | 0.4 Percentage of participants |
| Placebo | Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination | 1.7 Percentage of participants |
Secondary
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination
Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 29
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination | 0.0 Percentage of participants |
Secondary
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Time frame: Study Days 1 - 15
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever >/= 101 degrees Fahrenheit | 0.4 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Cough | 5.4 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever > 103 degrees Fahrenheit | 0.0 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Vomiting | 0.4 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Perecentage of participants reporting any symptom | 41.5 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Muscle aches | 5.8 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Runny nose | 19.1 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Chills | 1.2 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever > 102 degrees Fahrenheit | 0.0 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Decreased activity (tiredness) | 8.7 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Sore throat | 14.9 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Headache | 17.4 Percentage of participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever > 100 degrees Fahrenheit | 1.2 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Headache | 11.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever > 100 degrees Fahrenheit | 1.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Perecentage of participants reporting any symptom | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever >/= 101 degrees Fahrenheit | 1.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever > 102 degrees Fahrenheit | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Fever > 103 degrees Fahrenheit | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Runny nose | 13.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Sore throat | 5.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Cough | 3.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Vomiting | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Muscle aches | 3.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Chills | 3.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination | Decreased activity (tiredness) | 8.3 Percentage of participants |
Secondary
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Time frame: Study Days 1- 8
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Muscle aches | 5.0 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Chills | 1.2 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Decreased activity (tiredness) | 8.7 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Headache | 15.8 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Any symptom | 38.6 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever > 100 degrees Fahrenheit | 0.8 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever >/= 101 degrees Fahrenheit | 0.0 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever > 102 degrees Fahrenheit | 0.0 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever > 103 degrees Fahrenheit | 0.0 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Runny nose | 18.3 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Sore throat | 14.1 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Cough | 4.1 Percentage of Participants |
| Trivalent Influenza Virus Vaccine | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Vomiting | 0.4 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Sore throat | 5.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever > 102 degrees Fahrenheit | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Chills | 3.3 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Vomiting | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Decreased activity (tiredness) | 6.7 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever > 103 degrees Fahrenheit | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Headache | 10.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Cough | 1.7 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Any symptom | 20.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Runny nose | 8.3 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever > 100 degrees Fahrenheit | 1.7 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Muscle aches | 3.3 Percentage of Participants |
| Placebo | Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination | Fever >/= 101 degrees Fahrenheit | 1.7 Percentage of Participants |
Secondary
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.
Time frame: Study Days 1 - 15
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination | 2.1 Percentage of Participants |
| Placebo | Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination | 3.3 Percentage of Participants |
Secondary
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.
Time frame: Study Days 1 - 8
Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trivalent Influenza Virus Vaccine | Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination | 2.1 Percentage of Participants |
| Placebo | Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination | 3.3 Percentage of Participants |