A Clinical Study to Assess the Safety of a New Influenza Vaccine

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01104493
• Collaborator: (none)
• Enrollment: 300
• Locations: 3
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 100
• Patients Per Site Per Month: 14.2

Study Details

Study Description

Brief Summary

To assess the safety of a new influenza virus vaccine containing a new virus strain in healthy patients prior to the release of the vaccine.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: Monovalent Frozen FluMist®; Other: Placebo	Phase 4

Detailed Description

This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18-49 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. This study will be conducted at multiple sites in the United States. Randomization will be stratified by site.

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 receipt of investigational product through 180 days after receipt of investigational product.

To summarize the primary safety phase data (Study Days 1-8), the study will be unblinded to the analysis team at MedImmune after all data through at least Study Day 8 are locked.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety of a New 6:2 Influenza Virus Reassortant
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Single dose of monovalent vaccine	Biological: Monovalent Frozen FluMist®; Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.
Placebo Comparator: 2 Placebo	Other: Placebo; Single dose of placebo (60 subjects) by intranasal spray on Study Day 1

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F [Study Days 1-8]

   A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.

Secondary Outcome Measures

1. Percentage of Participants Reporting Any Solicited Symptom [Study Days 1-8]

   Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.

2. Percentage of Participants Reporting Any Adverse Event. [Study Days 1-8]

   An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

3. Percentage of Participants Reporting Any Solicited Symptom. [Study Days 1-15]

   Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.

4. Percentage of Participants Reporting Any Adverse Event. [Study Days 1-15]

   An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

5. Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29 [Study Days 1-29]

   SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.

6. Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181 [Study Days 1-181]

   SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female, 18 through 49 years of age (not yet reached their 50th birthday) at the time of investigational product administration

• Healthy by medical history and physical examination

• Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States of America, European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations

• Female subjects of child-bearing potential, (ie, unless at least 2 years postmenopausal, surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to administration of investigational product, and must agree to continue using such precautions for 60 days after investigational product administration. In addition, the subject 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.

• Males, unless surgically sterile must use an effective method of birth control with a female partner and must agree to continue using such contraceptive precautions for at least 30 days after dosing with investigational product (from Study Day 1 through Study Day 31)

• Subject available by telephone

• Ability to understand and comply with the requirements of the protocol, as judged by the investigator

• Ability to complete follow-up period of 180 days after dosing as required by the protocol

Exclusion Criteria:

• 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

• History of hypersensitivity to gentamicin

• 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 Note: A history of asthma that requires regular medical follow-up or hospitalization during the preceding 2 years is exclusionary. Investigator judgment is required to determine whether or not a subject has a history of asthma; however, for adult subjects, a remote history of wheezing or a remote diagnosis of asthma that the investigator does not consider to be relevant to current health does not need to be considered to be a history of asthma. For example, childhood asthma that has not required treatment in adulthood is not necessarily exclusionary

• 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

• Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus (HIV) infection, or ongoing immunosuppressive therapy

• History of Guillain-Barré syndrome

• 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 receipt of investigational product

• Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product

• Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after receipt of investigational product

• Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product Note: A daily dose of up to 81 mg of aspirin for prophylactic use is not considered a contraindication to enrollment.

• Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product

• Receipt of influenza antiviral therapy or antiviral agents within 48 hours prior to investigational product administration or expected receipt of influenza antiviral therapy or antiviral agents through 14 days after receipt of each dose of investigational product

• Known or suspected mitochondrial encephalomyopathy

• Nursing mother

• Any condition (eg, chronic cough) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

• Employees of the clinical study site, any other individuals involved with the conduct of the study, or immediate family members of such individuals

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami Research Associates	South Miami	Florida	United States	33143
2	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
3	Columbia Research Group, Inc	Portland	Oregon	United States	97239

Sponsors and Collaborators

• MedImmune LLC

Investigators

• Study Director: Robert A. Gasser, Jr., M.D., MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01104493
• Other Study ID Numbers: CD-VA-FluMist-1045
• First Posted: Apr 15, 2010
• Last Update Posted: Jul 18, 2011
• Last Verified: Jul 1, 2011

Study Results

Participant Flow

Recruitment Details	Three investigators at 3 clinical research units in the United States of America (USA) enrolled 300 subjects in May, 2010.

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Period Title: Overall Study
STARTED	240	60
COMPLETED	240	58
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo	Total
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.	Total of all reporting groups
Overall Participants	240	60	300
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.5 (8.8)	32.4 (8.3)	32.5 (8.7)
Sex: Female, Male (Count of Participants)
Female	127 52.9%	29 48.3%	156 52%
Male	113 47.1%	31 51.7%	144 48%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F
Description	A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.
Time Frame	Study Days 1-8

Outcome Measure Data

Analysis Population Description

All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Measure Participants	240	60
Number [Percentage of participants]	0.4 0.2%	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Monovalent Influenza Virus Vaccine, Placebo
	Comments	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 (Monovalent vaccine minus Placebo) evaluated against the prespecified equivalence criterion of 5 percentage points.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	H0 (null): Rate difference ≥ 5 percentage points This corresponded to a null hypothesis of: HA (alternative): rate difference < 5 percentage points.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	rate difference
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -5.2 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Reporting Any Solicited Symptom
Description	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

Outcome Measure Data

Analysis Population Description

All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Measure Participants	240	60
Any symptom	33.8 14.1%	40.0 66.7%
Fever > 100F	0.8 0.3%	0.0 0%
Fever > 102F	0.0 0%	0.0 0%
Fever > 103F	0.0 0%	0.0 0%
Runny nose	13.3 5.5%	18.3 30.5%
Sore throat	8.8 3.7%	5.0 8.3%
Cough	7.5 3.1%	6.7 11.2%
Vomiting	0.8 0.3%	0.0 0%
Muscle aches	5.8 2.4%	3.3 5.5%
Chills	2.5 1%	1.7 2.8%
Decreased activity (tiredness)	8.3 3.5%	6.7 11.2%
Headache	16.7 7%	16.7 27.8%

3. Secondary Outcome

Title	Percentage of Participants Reporting Any Adverse Event.
Description	An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame	Study Days 1-8

Outcome Measure Data

Analysis Population Description

All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Measure Participants	240	60
Number [Percentage of participants]	3.8 1.6%	3.3 5.5%

4. Secondary Outcome

Title	Percentage of Participants Reporting Any Solicited Symptom.
Description	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

Outcome Measure Data

Analysis Population Description

All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Measure Participants	240	60
Any Symptom	38.3 16%	50.0 83.3%
Fever > 100F	1.7 0.7%	1.7 2.8%
Fever ≥ 101F	0.8 0.3%	1.7 2.8%
Fever > 102F	0.0 0%	0.0 0%
Fever > 103F	0.0 0%	0.0 0%
Runny nose	17.1 7.1%	21.7 36.2%
Sore throat	10.8 4.5%	8.3 13.8%
Cough	8.8 3.7%	6.7 11.2%
Vomiting	1.3 0.5%	0.0 0%
Muscle aches	7.5 3.1%	6.7 11.2%
Chills	3.3 1.4%	1.7 2.8%
Decreased activity (tiredness)	8.8 3.7%	8.3 13.8%
Headache	19.2 8%	25.0 41.7%

5. Secondary Outcome

Title	Percentage of Participants Reporting Any Adverse Event.
Description	An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame	Study Days 1-15

Outcome Measure Data

Analysis Population Description

All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Measure Participants	240	60
Number [Percentage of participants]	4.2 1.8%	3.3 5.5%

6. Secondary Outcome

Title	Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29
Description	SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Time Frame	Study Days 1-29

Outcome Measure Data

Analysis Population Description

All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Measure Participants	240	60
Total participants reporting ≥ one SAE	0.0 0%	0.0 0%
Total participants reporting ≥ one NOCD	0.0 0%	0.0 0%

7. Secondary Outcome

Title	Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181
Description	SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Time Frame	Study Days 1-181

Outcome Measure Data

Analysis Population Description

All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)

Arm/Group Title	Monovalent Influenza Virus Vaccine	Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.	Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
Measure Participants	240	60
Total participants reporting ≥ one SAE	1.3 0.5%	0.0 0%
Total participants reporting ≥ one NOCD	0.0 0%	0.0 0%

Adverse Events

Time Frame	From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
Arm/Group Title	Monovalent Influenza Virus Vaccine		Placebo
Arm/Group Description	Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.		Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
All Cause Mortality
	Monovalent Influenza Virus Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Monovalent Influenza Virus Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/240 (1.3%)		0/60 (0%)
Gastrointestinal disorders
oesophageal perforation	1/240 (0.4%)	1	0/60 (0%)	0
Infections and infestations
diverticulitis	1/240 (0.4%)	1	0/60 (0%)	0
Musculoskeletal and connective tissue disorders
rotator cuff syndrome	1/240 (0.4%)	1	0/60 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leiomyoma	1/240 (0.4%)	1	0/60 (0%)	0
Reproductive system and breast disorders
menometrorrhagia	1/240 (0.4%)	1	0/60 (0%)	0
Other (Not Including Serious) Adverse Events
	Monovalent Influenza Virus Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/240 (2.5%)		2/60 (3.3%)
Psychiatric disorders
Depressed mood	0/240 (0%)	0	1/60 (1.7%)	1
Respiratory, thoracic and mediastinal disorders
Sneezing	4/240 (1.7%)	4	1/60 (1.7%)	2
Sinus congestion	0/240 (0%)	0	1/60 (1.7%)	1
Skin and subcutaneous tissue disorders
Rash	2/240 (0.8%)	3	0/60 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.