Trial Outcomes & Findings for A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults (NCT NCT00945893)
NCT ID: NCT00945893
Last Updated: 2011-09-12
Results Overview
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%
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
Days 1-8
Results posted on
2011-09-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo
Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
240
|
|
Overall Study
Day 15 Post Dose 1
|
60
|
238
|
|
Overall Study
Day 15 Post Dose 2
|
54
|
226
|
|
Overall Study
COMPLETED
|
57
|
230
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
8
|
|
Overall Study
Withdrawal of consent
|
1
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
34.1 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
33.3 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
33.5 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 participants
n=99 Participants
|
37 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
47 participants
n=99 Participants
|
199 participants
n=107 Participants
|
246 participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race (NIH/OMB)
Other
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Days 1-8Population: Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
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%
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 15Population: 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.
Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=30 Participants
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 [Influenza A (H1N1) Vaccine]
n=120 Participants
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.
|
|---|---|---|
|
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
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: 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.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=29 Participants
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 [Influenza A (H1N1) Vaccine]
n=115 Participants
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.
|
|---|---|---|
|
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
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 57Population: 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.
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=54 Participants
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 [Influenza A (H1N1) Vaccine]
n=222 Participants
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.
|
|---|---|---|
|
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
|
33 Participants
|
SECONDARY outcome
Timeframe: Days 1-8Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1
|
19 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: Days 1-8Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1
|
7 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Days 1-8Population: The Safety population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.
|
3 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Days 1-15Population: 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.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1
|
28 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: Days 1-15Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1
|
10 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Days 1-15Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1
|
3 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Days 29-36Population: 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.
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2
|
15 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Days 29-36Population: Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Days 29-36Population: Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 29-43Population: Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2
|
17 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Days 29-43Population: Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2
|
4 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Days 29-43Population: Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Days 1-29Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
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.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1-29Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
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).
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 29-57Population: Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.
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.
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 29-57Population: Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.
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).
Outcome measures
| Measure |
Placebo
n=55 Participants
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 [Influenza A (H1N1) Vaccine]
n=228 Participants
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.
|
|---|---|---|
|
Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1-209Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
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.
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants With SAEs Through 180 Days Post Final Dose
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 1-209Population: The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.
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).
Outcome measures
| Measure |
Placebo
n=60 Participants
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 [Influenza A (H1N1) Vaccine]
n=240 Participants
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.
|
|---|---|---|
|
Number of Participants With NOCDs Through 180 Days Post Final Dose.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15Population: 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.
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=30 Participants
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 [Influenza A (H1N1) Vaccine]
n=120 Participants
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.
|
|---|---|---|
|
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
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29Population: 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.
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=29 Participants
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 [Influenza A (H1N1) Vaccine]
n=115 Participants
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.
|
|---|---|---|
|
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
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 57Population: 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.
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=54 Participants
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 [Influenza A (H1N1) Vaccine]
n=222 Participants
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.
|
|---|---|---|
|
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
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15Population: 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.
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=30 Participants
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 [Influenza A (H1N1) Vaccine]
n=120 Participants
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.
|
|---|---|---|
|
Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)
|
2.64 Titer
Interval 2.0 to 32.0
|
3.46 Titer
Interval 2.0 to 256.0
|
SECONDARY outcome
Timeframe: Day 1, Day 29Population: 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.
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=29 Participants
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 [Influenza A (H1N1) Vaccine]
n=115 Participants
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.
|
|---|---|---|
|
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)
|
4.96 Titer
Interval 2.0 to 512.0
|
3.44 Titer
Interval 2.0 to 128.0
|
SECONDARY outcome
Timeframe: Day 1, Day 57Population: 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.
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
Placebo
n=54 Participants
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 [Influenza A (H1N1) Vaccine]
n=222 Participants
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.
|
|---|---|---|
|
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)
|
3.90 Titer
Interval 2.0 to 512.0
|
4.86 Titer
Interval 2.0 to 1024.0
|
Adverse Events
H1N1 Monovalent Vaccine Days 1-15
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo Days 1-15
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
H1N1 Monovalent Vaccine Days 29-57
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Days 29-57
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
H1N1 Monovalent Days 58-209
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Days 58-209
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
H1N1 Monovalent Vaccine Days 1-15
n=240 participants at risk
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 Days 1-15
n=60 participants at risk
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.
|
H1N1 Monovalent Vaccine Days 29-57
n=228 participants at risk
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 Days 29-57
n=55 participants at risk
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.
|
H1N1 Monovalent Days 58-209
n=240 participants at risk
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 Days 58-209
n=60 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/228 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
1.7%
1/60 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/228 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.42%
1/240 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/228 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
1.7%
1/60 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/228 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.42%
1/240 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Psychiatric disorders
Depression
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/228 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.42%
1/240 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
Other adverse events
| Measure |
H1N1 Monovalent Vaccine Days 1-15
n=240 participants at risk
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 Days 1-15
n=60 participants at risk
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.
|
H1N1 Monovalent Vaccine Days 29-57
n=228 participants at risk
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 Days 29-57
n=55 participants at risk
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.
|
H1N1 Monovalent Days 58-209
n=240 participants at risk
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 Days 58-209
n=60 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Ear infection
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
3.3%
2/60 • Number of events 2 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/228 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
4/240 • Number of events 4 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
3.3%
2/60 • Number of events 2 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
1.8%
4/228 • Number of events 4 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
5/240 • Number of events 5 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
3.3%
2/60 • Number of events 2 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.44%
1/228 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.7%
4/240 • Number of events 4 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
3.3%
2/60 • Number of events 2 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
1.3%
3/228 • Number of events 3 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
1.8%
1/55 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.7%
4/240 • Number of events 4 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
1.7%
1/60 • Number of events 1 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
2.2%
5/228 • Number of events 5 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/55 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/240 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
0.00%
0/60 • Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.
|
Additional Information
Raburn Mallory, MD Senior Director Clinical Development
MedImmune, LLC
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER