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| ID | Type | Description | Link |
|---|---|---|---|
| HHS/ASPR | Other Grant/Funding Number | HHSO100200900002I |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.
The primary objective of this study was to assess the safety and descriptive immunogenicity of a monovalent influenza virus vaccine containing a new 6:2 influenza virus reassortant in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI3414 [Influenza A (H1N1) vaccine] | Experimental | MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants. |
|
| Placebo | Placebo Comparator | Placebo -Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] | Biological | 0.5 mL; (intranasal sprayer) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral 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 (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI 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 Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population. | Day 1, Day 15 |
| Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population. | Day 1, Day 29 |
| Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population. | Day 1, Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1 | Solicited symptoms were events considered likely to occur post dosing. For this study, other solicited symptoms included: Fever (> 100°F [37.8°C] oral), Runny nose, Sore throat, Cough, Vomiting, Muscle aches, Chills, Decreased activity (tiredness), and Headache. | Days 1-8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raburn Mallory, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Daytona Beach | Daytona Beach | Florida | 30060 | United States | ||
| Pharmax Research Clinic |
| 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. |
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Eligible subjects were randomly assigned in a 4:1 ratio to receive 2 doses of monovalent vaccine or placebo by intranasal spray; the doses were administered approximately 28 days apart, on Days 1 and 29.
Subjects were screened for the study within 14 days prior to randomization. The first and last dates of informed consent were 03 Aug 2009 and 18 Aug 2009. Once informed consent was obtained, a subject identification number was assigned using an interactive voice response system, and screening evaluations began to assess study eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29. |
| FG001 | MEDI3414 [Influenza A (H1N1) Vaccine] | MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29. |
| BG001 | MEDI3414 [Influenza A (H1N1) Vaccine] |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Oral 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 (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI 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% | Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-8 |
|
Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | H1N1 Monovalent Vaccine Days 1-15 | A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raburn Mallory, MD Senior Director Clinical Development | MedImmune, LLC | 301-398-0000 | malloryr@medimmune.com |
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| Placebo | Other | (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer) |
|
| Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1 | Days 1-8 |
| Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1. | Days 1-8 |
| Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1 | Days 1-15 |
| Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1 | Days 1-15 |
| Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1 | Days 1-15 |
| Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2 | Days 29-36 |
| Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2 | Days 29-36 |
| Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2 | Days 29-36 |
| Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2 | Days 29-43 |
| Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2 | Days 29-43 |
| Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2 | Days 29-43 |
| Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, 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 birth defect 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. | Days 1-29 |
| Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, 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). | Days 1-29 |
| Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2 | 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 birth defect 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. | Days 29-57 |
| Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2 | 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). | Days 29-57 |
| Number of Participants With SAEs Through 180 Days Post Final Dose | 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 birth defect 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. | Days 1-209 |
| Number of Participants With NOCDs Through 180 Days Post Final Dose. | 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). | Days 1-209 |
| Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | All immunogenicity analyses are based on the immunogenicity population. | Day 1, Day 15 |
| Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus | All immunogenicity analyses are based on the immunogenicity population. | Day 1, Day 29 |
| Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | All immunogenicity analyses are based on the immunogenicity population. | Day 1, Day 57 |
| 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. | Day 1, Day 15 |
| Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29) | All immunogenicity analyses are based on the immunogenicity population. | Day 1, Day 29 |
| Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29) | All immunogenicity analyses are based on the immunogenicity population. | Day 1, Day 57 |
| Miami |
| Florida |
| 33126 |
| United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number | participants |
|
| OG001 | MEDI3414 [Influenza A (H1N1) Vaccine] | MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants. |
|
|
|
| Primary | Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population. | For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis. | Posted | Number | Participants | Day 1, Day 15 |
|
|
|
|
| Primary | Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population. | For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis. | Posted | Number | Participants | Day 1, Day 29 |
|
|
|
|
| Primary | Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population. | Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis. | Posted | Number | Participants | Day 1, Day 57 |
|
|
|
|
| Secondary | Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1 | Solicited symptoms were events considered likely to occur post dosing. For this study, other solicited symptoms included: Fever (> 100°F [37.8°C] oral), Runny nose, Sore throat, Cough, Vomiting, Muscle aches, Chills, Decreased activity (tiredness), and Headache. | The Safety population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period. | Posted | Number | Participants | Days 1-8 |
|
|
|
|
| Secondary | Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1 | The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-8 |
|
|
|
| Secondary | Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1. | The Safety population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-8 |
|
|
|
| Secondary | Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1 | The Safety Population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period. | Posted | Number | Participants | Days 1-15 |
|
|
|
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| Secondary | Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1 | The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-15 |
|
|
|
| Secondary | Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1 | The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-15 |
|
|
|
| Secondary | Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2 | The Safety Population for solicited symptoms dose 2 was defined as all participants who received Dose 2, had any follow-up for safety and had solicited symptom data available during the reporting period. | Posted | Number | Participants | Days 29-36 |
|
|
|
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| Secondary | Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2 | Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period. | Posted | Number | Participants | Days 29-36 |
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| Secondary | Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2 | Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period. | Posted | Number | Participants | Days 29-36 |
|
|
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| Secondary | Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2 | Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period. | Posted | Number | Participants | Days 29-43 |
|
|
|
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| Secondary | Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2 | Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period. | Posted | Number | Participants | Days 29-43 |
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| Secondary | Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2 | Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period. | Posted | Number | Participants | Days 29-43 |
|
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, 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 birth defect 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-29 |
|
|
|
| Secondary | Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-29 |
|
|
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| Secondary | Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2 | 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 birth defect 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. | Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period. | Posted | Number | Participants | Days 29-57 |
|
|
|
| Secondary | Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2 | 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). | Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period. | Posted | Number | Participants | Days 29-57 |
|
|
|
| Secondary | Number of Participants With SAEs Through 180 Days Post Final Dose | 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 birth defect 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-209 |
|
|
|
| Secondary | Number of Participants With NOCDs Through 180 Days Post Final Dose. | 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety. | Posted | Number | Participants | Days 1-209 |
|
|
|
| Secondary | Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | All immunogenicity analyses are based on the immunogenicity population. | Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis. | Posted | Number | Participants | Day 1, Day 15 |
|
|
|
|
| Secondary | Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus | All immunogenicity analyses are based on the immunogenicity population. | Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis. | Posted | Number | Participants | Day 1, Day 29 |
|
|
|
|
| Secondary | Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 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 investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis. | Posted | Number | Participants | Day 1, Day 57 |
|
|
|
|
| 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. | Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis. | Posted | Geometric Mean | Full Range | Titer | Day 1, Day 15 |
|
|
|
| Secondary | Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29) | All immunogenicity analyses are based on the immunogenicity population. | Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis. | Posted | Geometric Mean | Full Range | Titer | Day 1, Day 29 |
|
|
|
| Secondary | Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29) | All immunogenicity analyses are based on the immunogenicity population. | Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis. | Posted | Geometric Mean | Full Range | Titer | Day 1, Day 57 |
|
|
|
| 0 |
| 240 |
| 17 |
| 240 |
| EG001 | Placebo Days 1-15 | Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29. | 0 | 60 | 9 | 60 |
| EG002 | H1N1 Monovalent Vaccine Days 29-57 | A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29. | 0 | 228 | 13 | 228 |
| EG003 | Placebo Days 29-57 | Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29. | 0 | 55 | 1 | 55 |
| EG004 | H1N1 Monovalent Days 58-209 | A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29. | 3 | 240 | 0 | 240 |
| EG005 | Placebo Days 58-209 | Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29. | 2 | 60 | 0 | 60 |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
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