A Study to Evaluate the Safety of 3 New 6:2 Influenza Vir... | NCT01579916

NCT01579916

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
AstraZeneca	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trivalent Influenza Virus Vaccine	Experimental	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.	Biological: Trivalent Influenza Virus Vaccine
Placebo	Placebo Comparator	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.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trivalent Influenza Virus Vaccine	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Study Days 1 - 8

Secondary Outcomes

Measure	Description	Time Frame
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.	Study Days 1- 8
Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 through 49 years at the time of investigational product administration
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
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
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
Healthy by medical history and physical examination
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.
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:

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
Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
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
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 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 study vaccination
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)
Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after study vaccination
Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after study vaccination
Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
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
Known or suspected mitochondrial encephalomyopathy
Nursing mother

Name	Affiliation	Role
Raburn Mallory, MD	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Miami	Florida	33143	United States
Research Site

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

All participants who received a single dose of investigational product (trivalent influenza vaccine = 241; placebo = 60).

Posted

Number

Percentage of Participants

Study Days 1 - 8

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections