Healthy
Conditions
Brief summary
The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.
Detailed description
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.
Interventions
BIOLOGICALMEDI3414 [Influenza A/H1N1 live attenuated, intranasal]
0.5 mL; (intranasal sprayer)
OTHERPlacebo
(intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)
Sponsors
Department of Health and Human Services
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of randomization * Healthy by medical history and physical examination * 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) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations * Females of childbearing potential, (ie, unless surgically sterile \[eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\], has sterile male partner, is at least 1 year post menopause, 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. * 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 is available by telephone * Subject is able to understand and comply with the requirements of the protocol, as judged by the investigator * Subject is able 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 * 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) * Expected receipt of antipyretic or analgesic medication 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 * 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). | Days 1-8 | 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% |
| Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Day 1, Day 15 | Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population. |
| Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Day 1, Day 29 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population. |
| Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | Day 1, Day 57 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Days 1-29 | 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. |
| Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1 | Days 1-29 | 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). |
| Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1 | Days 1-8 | 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. |
| Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2 | Days 29-57 | 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). |
| Number of Participants With SAEs Through 180 Days Post Final Dose | Days 1-209 | 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. |
| Number of Participants With NOCDs Through 180 Days Post Final Dose. | Days 1-209 | 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). |
| 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 | Day 1, Day 15 | All immunogenicity analyses are based on the immunogenicity population. |
| 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 | Day 1, Day 29 | All immunogenicity analyses are based on the immunogenicity population. |
| 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 | Day 1, Day 57 | All immunogenicity analyses are based on the immunogenicity population. |
| Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15) | Day 1, Day 15 | All immunogenicity analyses are based on the immunogenicity population. |
| Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29) | Day 1, Day 29 | All immunogenicity analyses are based on the immunogenicity population. |
| Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29) | Day 1, Day 57 | All immunogenicity analyses are based on the immunogenicity population. |
| Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2 | Days 29-57 | 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. |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 240 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 8 |
| Overall Study | Withdrawal of consent | 1 | 2 |
Baseline characteristics
| Characteristic | MEDI3414 [Influenza A (H1N1) Vaccine] | Total | Placebo |
|---|---|---|---|
| Age Continuous | 33.3 years STANDARD_DEVIATION 9.2 | 33.5 years STANDARD_DEVIATION 9.2 | 34.1 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 95 Participants | 113 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants | 187 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) Asian | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) Black or African American | 37 participants | 50 participants | 13 participants |
| Race (NIH/OMB) More than one race | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) Other | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) White | 199 participants | 246 participants | 47 participants |
| Sex: Female, Male Female | 138 Participants | 171 Participants | 33 Participants |
| Sex: Female, Male Male | 102 Participants | 129 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 240 | 9 / 60 | 13 / 228 | 1 / 55 | 0 / 240 | 0 / 60 |
| serious Total, serious adverse events | 0 / 240 | 0 / 60 | 0 / 228 | 0 / 55 | 3 / 240 | 2 / 60 |
Outcome results
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.
Time frame: Day 1, Day 15
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | 0 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | 3 Participants |
Comparison: The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).95% CI: [-8.8, 7.7]score
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.
Time frame: Day 1, Day 29
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | 0 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | 7 Participants |
Comparison: The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs for the rate difference (Vaccine minus Placebo).95% CI: [-5.6, 12.6]score
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.
Time frame: Day 1, Day 57
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | 3 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus | 33 Participants |
Comparison: The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).95% CI: [-0.8, 16.3]score
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%
Time frame: Days 1-8
Population: Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). | 0 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). | 0 Participants |
Comparison: 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%95% CI: [-6, 1.9]Score
Secondary
Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1
Time frame: Days 1-8
Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1 | 7 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1 | 26 Participants |
Secondary
Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1
Time frame: Days 1-15
Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1 | 10 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1 | 38 Participants |
Secondary
Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2
Time frame: Days 29-43
Population: Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2 | 4 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2 | 18 Participants |
Secondary
Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2
Time frame: Days 29-36
Population: Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2 | 3 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2 | 12 Participants |
Secondary
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2
Time frame: Days 29-43
Population: Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2 | 2 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2 | 10 Participants |
Secondary
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.
Time frame: Days 1-8
Population: The Safety population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1. | 3 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1. | 20 Participants |
Secondary
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2
Time frame: Days 29-36
Population: Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2 | 2 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2 | 4 Participants |
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.
Time frame: Day 1, Day 15
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 | 1 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | 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 | 11 Participants |
Comparison: The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).95% CI: [-7.7, 13.8]score
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.
Time frame: Day 1, Day 29
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 | 4 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | 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 | 9 Participants |
Comparison: The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).95% CI: [-23.5, 5.3]score
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.
Time frame: Day 1, Day 57
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 | 6 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | 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 | 30 Participants |
Comparison: The number of participants who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).95% CI: [-9.3, 10.8]score
Secondary
Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1
Time frame: Days 1-15
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1 | 28 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1 | 113 Participants |
95% CI: [-13.9, 14.5]Score
Secondary
Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2
Time frame: Days 29-43
Population: Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2 | 17 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2 | 75 Participants |
95% CI: [-12.6, 14.9]Score
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.
Time frame: Days 1-8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1 | 19 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1 | 100 Participants |
95% CI: [-4.1, 22.8]Score
Secondary
Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2
Time frame: Days 29-36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2 | 15 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2 | 61 Participants |
95% CI: [-14.7, 11.8]Score
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).
Time frame: Days 1-29
Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1 | 0 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1 | 1 Participants |
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).
Time frame: Days 1-209
Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With NOCDs Through 180 Days Post Final Dose. | 1 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With NOCDs Through 180 Days Post Final Dose. | 1 Participants |
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).
Time frame: Days 29-57
Population: Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2 | 0 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2 | 0 Participants |
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.
Time frame: Days 1-209
Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With SAEs Through 180 Days Post Final Dose | 2 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With SAEs Through 180 Days Post Final Dose | 3 Participants |
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.
Time frame: Days 29-57
Population: Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2 | 0 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2 | 0 Participants |
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.
Time frame: Days 1-29
Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1 | 0 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1 | 0 Participants |
Secondary
Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1
Time frame: Days 1-15
Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1 | 3 Participants |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1 | 30 Participants |
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.
Time frame: Day 1, Day 15
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15) | 2.64 Titer |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15) | 3.46 Titer |
Secondary
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)
All immunogenicity analyses are based on the immunogenicity population.
Time frame: Day 1, Day 29
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29) | 4.96 Titer |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29) | 3.44 Titer |
Secondary
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)
All immunogenicity analyses are based on the immunogenicity population.
Time frame: Day 1, Day 57
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29) | 3.90 Titer |
| MEDI3414 [Influenza A (H1N1) Vaccine] | Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29) | 4.86 Titer |