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A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults (MI-CP215)

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ClinicalTrials.gov Identifier: NCT00945893
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : September 5, 2011
Last Update Posted : September 12, 2011
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Healthy
Interventions Biological: MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]
Other: Placebo
Enrollment 300
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.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 60 240
Day 15 Post Dose 1 60 238
Day 15 Post Dose 2 54 226
Completed 57 230
Not Completed 3 10
Reason Not Completed
Lost to Follow-up             2             8
Withdrawal of consent             1             2
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine] Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 60 240 300
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 240 participants 300 participants
34.1  (8.9) 33.3  (9.2) 33.5  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 240 participants 300 participants
Female
33
  55.0%
138
  57.5%
171
  57.0%
Male
27
  45.0%
102
  42.5%
129
  43.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 240 participants 300 participants
Hispanic or Latino
18
  30.0%
95
  39.6%
113
  37.7%
Not Hispanic or Latino
42
  70.0%
145
  60.4%
187
  62.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 240 participants 300 participants
American Indian or Alaska Native 0 1 1
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 13 37 50
White 47 199 246
More than one race 0 1 1
Unknown or Not Reported 0 0 0
Other 0 1 1
1.Primary Outcome
Title Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments 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%
Type of Statistical Test Non-Inferiority or Equivalence
Comments The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Score
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-6.0 to 1.9
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 30 120
Measure Type: Number
Unit of Measure: Participants
0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method score
Comments [Not Specified]
Method of Estimation Estimation Parameter rate difference
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-8.8 to 7.7
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 29 115
Measure Type: Number
Unit of Measure: Participants
0 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method score
Comments [Not Specified]
Method of Estimation Estimation Parameter rate difference
Estimated Value 6.1
Confidence Interval (2-Sided) 95%
-5.6 to 12.6
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 54 222
Measure Type: Number
Unit of Measure: Participants
3 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method score
Comments [Not Specified]
Method of Estimation Estimation Parameter rate difference
Estimated Value 9.3
Confidence Interval (2-Sided) 95%
-0.8 to 16.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
19 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Score
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-4.1 to 22.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1
Hide Description [Not Specified]
Time Frame Days 1-8
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
7 26
7.Secondary Outcome
Title Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.
Hide Description [Not Specified]
Time Frame Days 1-8
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
3 20
8.Secondary Outcome
Title Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1
Hide Description [Not Specified]
Time Frame Days 1-15
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
28 113
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Score
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-13.9 to 14.5
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1
Hide Description [Not Specified]
Time Frame Days 1-15
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
10 38
10.Secondary Outcome
Title Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1
Hide Description [Not Specified]
Time Frame Days 1-15
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
3 30
11.Secondary Outcome
Title Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2
Hide Description [Not Specified]
Time Frame Days 29-36
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
15 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Score
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-14.7 to 11.8
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2
Hide Description [Not Specified]
Time Frame Days 29-36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
3 12
13.Secondary Outcome
Title Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2
Hide Description [Not Specified]
Time Frame Days 29-36
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
2 4
14.Secondary Outcome
Title Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2
Hide Description [Not Specified]
Time Frame Days 29-43
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
17 75
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Score
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-12.6 to 14.9
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2
Hide Description [Not Specified]
Time Frame Days 29-43
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
4 18
16.Secondary Outcome
Title Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2
Hide Description [Not Specified]
Time Frame Days 29-43
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
2 10
17.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
0 0
18.Secondary Outcome
Title Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
0 1
19.Secondary Outcome
Title Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
0 0
20.Secondary Outcome
Title Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.
Arm/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 228
Measure Type: Number
Unit of Measure: Participants
0 0
21.Secondary Outcome
Title Number of Participants With SAEs Through 180 Days Post Final Dose
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
2 3
22.Secondary Outcome
Title Number of Participants With NOCDs Through 180 Days Post Final Dose.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 60 240
Measure Type: Number
Unit of Measure: Participants
1 1
23.Secondary Outcome
Title 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
Hide Description All immunogenicity analyses are based on the immunogenicity population.
Time Frame Day 1, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 30 120
Measure Type: Number
Unit of Measure: Participants
1 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method score
Comments [Not Specified]
Method of Estimation Estimation Parameter rate difference
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
-7.7 to 13.8
Estimation Comments [Not Specified]
24.Secondary Outcome
Title 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
Hide Description All immunogenicity analyses are based on the immunogenicity population.
Time Frame Day 1, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 29 115
Measure Type: Number
Unit of Measure: Participants
4 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method score
Comments [Not Specified]
Method of Estimation Estimation Parameter rate difference
Estimated Value -6.0
Confidence Interval (2-Sided) 95%
-23.5 to 5.3
Estimation Comments [Not Specified]
25.Secondary Outcome
Title 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
Hide Description All immunogenicity analyses are based on the immunogenicity population.
Time Frame Day 1, Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 54 222
Measure Type: Number
Unit of Measure: Participants
6 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MEDI3414 [Influenza A (H1N1) Vaccine]
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method score
Comments [Not Specified]
Method of Estimation Estimation Parameter rate difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-9.3 to 10.8
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)
Hide Description All immunogenicity analyses are based on the immunogenicity population.
Time Frame Day 1, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 30 120
Geometric Mean (Full Range)
Unit of Measure: Titer
2.64
(2 to 32)
3.46
(2 to 256)
27.Secondary Outcome
Title Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)
Hide Description All immunogenicity analyses are based on the immunogenicity population.
Time Frame Day 1, Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 29 115
Geometric Mean (Full Range)
Unit of Measure: Titer
4.96
(2 to 512)
3.44
(2 to 128)
28.Secondary Outcome
Title Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)
Hide Description All immunogenicity analyses are based on the immunogenicity population.
Time Frame Day 1, Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo MEDI3414 [Influenza A (H1N1) Vaccine]
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 54 222
Geometric Mean (Full Range)
Unit of Measure: Titer
3.90
(2 to 512)
4.86
(2 to 1024)
Time Frame 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.
Adverse Event Reporting Description Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
 
Arm/Group Title H1N1 Monovalent Vaccine Days 1-15 Placebo Days 1-15 H1N1 Monovalent Vaccine Days 29-57 Placebo Days 29-57 H1N1 Monovalent Days 58-209 Placebo Days 58-209
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
All-Cause Mortality
H1N1 Monovalent Vaccine Days 1-15 Placebo Days 1-15 H1N1 Monovalent Vaccine Days 29-57 Placebo Days 29-57 H1N1 Monovalent Days 58-209 Placebo Days 58-209
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
H1N1 Monovalent Vaccine Days 1-15 Placebo Days 1-15 H1N1 Monovalent Vaccine Days 29-57 Placebo Days 29-57 H1N1 Monovalent Days 58-209 Placebo Days 58-209
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/240 (0.00%)      0/60 (0.00%)      0/228 (0.00%)      0/55 (0.00%)      3/240 (1.25%)      2/60 (3.33%)    
Hepatobiliary disorders             
Gallbladder disorder  1  0/240 (0.00%)  0 0/60 (0.00%)  0 0/228 (0.00%)  0 0/55 (0.00%)  0 0/240 (0.00%)  0 1/60 (1.67%)  1
Infections and infestations             
Cellulitis  1  0/240 (0.00%)  0 0/60 (0.00%)  0 0/228 (0.00%)  0 0/55 (0.00%)  0 1/240 (0.42%)  1 0/60 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Cervix carcinoma  1  0/240 (0.00%)  0 0/60 (0.00%)  0 0/228 (0.00%)  0 0/55 (0.00%)  0 0/240 (0.00%)  0 1/60 (1.67%)  1
Pregnancy, puerperium and perinatal conditions             
Premature baby  1  0/240 (0.00%)  0 0/60 (0.00%)  0 0/228 (0.00%)  0 0/55 (0.00%)  0 1/240 (0.42%)  1 0/60 (0.00%)  0
Psychiatric disorders             
Depression  1  0/240 (0.00%)  0 0/60 (0.00%)  0 0/228 (0.00%)  0 0/55 (0.00%)  0 1/240 (0.42%)  1 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
H1N1 Monovalent Vaccine Days 1-15 Placebo Days 1-15 H1N1 Monovalent Vaccine Days 29-57 Placebo Days 29-57 H1N1 Monovalent Days 58-209 Placebo Days 58-209
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/240 (7.08%)      9/60 (15.00%)      13/228 (5.70%)      1/55 (1.82%)      0/240 (0.00%)      0/60 (0.00%)    
Gastrointestinal disorders             
Diarrhoea  1  4/240 (1.67%)  4 2/60 (3.33%)  2 4/228 (1.75%)  4 0/55 (0.00%)  0 0/240 (0.00%)  0 0/60 (0.00%)  0
Nausea  1  5/240 (2.08%)  5 2/60 (3.33%)  2 1/228 (0.44%)  1 0/55 (0.00%)  0 0/240 (0.00%)  0 0/60 (0.00%)  0
Infections and infestations             
Ear infection  1  0/240 (0.00%)  0 2/60 (3.33%)  2 0/228 (0.00%)  0 0/55 (0.00%)  0 0/240 (0.00%)  0 0/60 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Sneezing  1  4/240 (1.67%)  4 2/60 (3.33%)  2 3/228 (1.32%)  3 1/55 (1.82%)  1 0/240 (0.00%)  0 0/60 (0.00%)  0
Nasal Congestion  1  4/240 (1.67%)  4 1/60 (1.67%)  1 5/228 (2.19%)  5 0/55 (0.00%)  0 0/240 (0.00%)  0 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title: Raburn Mallory, MD Senior Director Clinical Development
Organization: MedImmune, LLC
Phone: 301-398-0000
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00945893     History of Changes
Other Study ID Numbers: MI-CP215
HHS/ASPR ( Other Grant/Funding Number: HHSO100200900002I )
First Submitted: July 23, 2009
First Posted: July 24, 2009
Results First Submitted: June 17, 2011
Results First Posted: September 5, 2011
Last Update Posted: September 12, 2011