A Study to Evaluate the Safety of HIN1 Monovalent Vaccine... | NCT00946101

ID	Type	Description	Link
HHS/ASPR	Other Grant/Funding Number	HHSO100200900002I

Status Module

Name	Class
Department of Health and Human Services	FED

Label	Type	Description	Intervention Names
MEDI3414 [Influenza A (H1N1) vaccine]	Active Comparator	MEDI3414- Monovalent vaccine was 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 influenza virus type A/California/07/2009.	Biological: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]
Placebo	Placebo Comparator	Placebo - Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]	Biological	0.5 mL: (intranasal sprayer)	MEDI3414 [Influenza A (H1N1) vaccine]

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).	The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.	Days 1- 8
Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus	Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.	Day 1, Day 15
Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus	Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.	Day 1, Day 29
Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus	Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.	Day 1, Day 57

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1	Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.	Days 1-8

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, 2 to 17 years of age (not yet reached their 18th birthday) at the time of randomization
Healthy by medical history and physical exam
Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU and written informed assent) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Females of child-bearing potential, (ie, unless premenarchal, 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 the first dose of investigational product, and must agree to continue using such precautions for 60 days after the second dose of investigational product. 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. Investigator judgment is required to assess the childbearing potential of a pre-adolescent or adolescent girl.
Males, unless not sexually active, 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 the second dose of investigational product (from Day 1 through Day 59 of the study)
Subject's legal representative available by telephone
Subject/subject's legal representative is able 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 Dose 2 as required by the protocol

Exclusion Criteria:

History of hypersensitivity to any component of the investigational product including egg or egg protein, gelatin or arginine, 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
History of asthma, or in children < 5 years of age, history of recurrent wheezing
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); subject should additionally 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 second dose of investigational product (use of licensed agents for indications not listed in the package insert is permitted)
Use of aspirin or salicylate-containing products within 30 days prior to randomization or expected receipt through 30 days after final vaccination
Expected receipt of antipyretic or analgesic medication (non-salicylate-containing) on a daily or every other day basis from randomization through 14 days after receipt of each dose of investigational product
Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of each dose of investigational product
Receipt of any nonstudy vaccine within 30 days before or after Dose 1 or expected receipt of any nonstudy vaccine within 30 days before or after Dose 2
Known or suspected mitochondrial encephalomyopathy
Adolescent subject is pregnant or a nursing mother
Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Subject, legal representative, or immediate family member of subject is an employee of the clinical study site or is otherwise in involved with the conduct of the study

Name	Affiliation	Role
Elissa Malkin, D.O.	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Clinic Research, Inc.		Mobile	Alabama	36608	United States
Benchmark Research

PubMed Identifier	Type	Citation	Retractions
21060780	Derived	Mallory RM, Malkin E, Ambrose CS, Bellamy T, Shi L, Yi T, Jones T, Kemble G, Dubovsky F. Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials. PLoS One. 2010 Oct 29;5(10):e13755. doi: 10.1371/journal.pone.0013755.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).

The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.

The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1- 8

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants	OG000259 OG00165

Title

Denominators

Categories

Title	Measurements
	OG0004 OG0011

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%	score				rate difference	0.0			2-Sided	95	-6.4	3.1				Yes	Non-Inferiority or Equivalence	For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.

Primary

Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.

Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).

Posted

Number

participants

Day 1, Day 15

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Primary

Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.

Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).

Posted

Jun 2010

Number

participants

Day 1, Day 29

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Primary

Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.

Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).

Posted

Jun 2010

Number

participants

Day 1, Day 57

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1

Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-8

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-8

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Jun 2010

Number

participants

Days 1-8

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety, and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-15

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-15

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-15

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2

The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).

Posted

Number

participants

Days 29-36

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2

The safety population included all participants who received Dose 2 (H1N1=258; Placebo) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Posted

Number

participants

Days 29-36

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2

The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Posted

Jun 2010

Number

participants

Days 29-36

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2

Posted

Number

participants

Days 29-43

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2

The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).

Posted

Number

participants

Days 29-43

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2

The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).

Posted

Number

participants

Days 29-43

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.

An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-29

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1

SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-29

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.

The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Posted

Number

participants

Days 29-57

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2

The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Posted

Number

participants

Days 29-57

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

Participants

Days 1-209

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.

The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Posted

Number

participants

Days 1-209

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Secondary

Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.

All immunogenicity analyses are based on the immunogenicity population.

Posted

Number

participants

Day 1, Day 15

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts

Secondary

Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.

All immunogenicity analyses are based on the immunogenicity population.

Posted

Number

participants

Day 1, Day 29

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts

Secondary

Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.

All immunogenicity analyses are based on the immunogenicity population.

Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).

Posted

Number

participants

Day 1, Day 57

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units

Secondary

Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)

All immunogenicity analyses are based on the immunogenicity population.

Posted

Geometric Mean

Full Range

titer

Day 1, Day 15

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts

Secondary

Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)

All immunogenicity analyses are based on the immunogenicity population.

Posted

Geometric Mean

Full Range

titer

Day 1, Day 29

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts
Participants

Secondary

Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)

All immunogenicity analyses are based on the immunogenicity population.

Posted

Geometric Mean

Full Range

titer

Day 1, Day 57

ID	Title	Description
OG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
OG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	H1N1 Monovalent Vaccine Days 1-28	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.	1	259	13	259
EG001	Placebo Days 1-28	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers	0	65	2	65
EG002	H1N1 Monvalent Vaccine Days 29-57	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.	0	255	11	255
EG003	Placebo Days 29-57	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.	0	63	3	63
EG004	H1N1 Monovalent Vaccine Days 58-209	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.	1	259	0	255
EG005	Placebo Days 58-209	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.	1	65	0	63

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected259 at risk EG0010 events0 affected65 at risk EG0020 events0 affected255 at risk EG0030 events0 affected63 at risk EG0040 events0 affected255 at risk EG0050 events0 affected63 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected259 at risk EG0010 events0 affected65 at risk EG0020 events0 affected255 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment	EG0000 events0 affected259 at risk EG0010 events0 affected65 at risk EG0020 events0 affected255 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0006 events5 affected259 at risk EG0012 events2 affected65 at risk EG0023 events2 affected255 at risk EG0032 events1 affected63 at risk EG0040 events0 affected255 at risk EG0050 events0 affected63 at risk
vomiting	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0007 events7 affected259 at risk EG0011 events1 affected65 at risk EG0026 events6 affected255 at risk EG003
diarrhea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected259 at risk EG0011 events1 affected65 at risk EG0025 events5 affected255 at risk EG003

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	H1N1 Monovalent Influenza Vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
BG001	Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
BG002	Total	Total of all reporting groups