Trial Outcomes & Findings for A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age (NCT NCT00946101)
NCT ID: NCT00946101
Last Updated: 2011-08-11
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 for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
326 participants
Primary outcome timeframe
Days 1- 8
Results posted on
2011-08-11
Participant Flow
Study participation began once written informed consent was obtained. The first and last dates of informed consent were 03 Aug 2009 and 19 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 study monovalent vaccine or placebo by intranasal spray; the doses were administered approximately 28 days apart, on Days 1 and 29.
Participant milestones
| Measure |
H1N1 Monovalent Influenza Vaccine
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Overall Study
STARTED
|
261
|
65
|
|
Overall Study
Day 15 Post Dose 1
|
260
|
64
|
|
Overall Study
Day 15 Post Dose 2
|
254
|
63
|
|
Overall Study
COMPLETED
|
257
|
63
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
H1N1 Monovalent Influenza Vaccine
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal of consent
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
Baseline characteristics by cohort
| Measure |
H1N1 Monovalent Influenza Vaccine
n=261 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
8.9 years
STANDARD_DEVIATION 4.3 • n=99 Participants
|
9.2 years
STANDARD_DEVIATION 4.3 • n=107 Participants
|
9.0 years
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
211 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
259 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
|
4 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 participants
n=99 Participants
|
12 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
198 participants
n=99 Participants
|
43 participants
n=107 Participants
|
241 participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 participants
n=99 Participants
|
1 participants
n=107 Participants
|
9 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
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Days 1- 8Population: The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).
The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).
|
4 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Day 1, Day 15Population: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).
Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=129 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=32 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
|
10 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).
Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=126 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=32 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
|
14 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Day 1, Day 57Population: Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).
Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=250 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=62 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
|
80 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Days 1-8Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).
Other solicited symptoms include fever (\> 100°F \[37.8°C\] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1
|
97 participants
|
21 participants
|
SECONDARY outcome
Timeframe: Days 1-8Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1
|
28 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Days 1-8Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1
|
18 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 1-15Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety, and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1
|
122 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Days 1-15Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1
|
47 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Days 1-15Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1
|
27 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Days 29-36Population: The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2
|
65 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Days 29-36Population: The safety population included all participants who received Dose 2 (H1N1=258; Placebo) and experienced any follow-up for safety (H1N1=255; Placebo=63).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2
|
20 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Days 29-36Population: The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2
|
10 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Days 29-43Population: The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2
|
93 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Days 29-43Population: The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2
|
35 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Days 29-43Population: The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2
|
22 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Days 1-29Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
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 |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1-29Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 29-57Population: The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).
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 |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Days 29-57Population: The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=255 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=63 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1-209Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
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 |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 1-209Population: The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=259 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=65 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15Population: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=129 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=32 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
|
13 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 29Population: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=126 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=32 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
|
13 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 57Population: Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=250 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=62 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
|
66 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15Population: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=129 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=32 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)
|
3.55 titer
Interval 2.0 to 128.0
|
2.89 titer
Interval 2.0 to 32.0
|
SECONDARY outcome
Timeframe: Day 1, Day 29Population: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=126 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=32 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)
|
3.53 titer
Interval 2.0 to 512.0
|
2.71 titer
Interval 2.0 to 64.0
|
SECONDARY outcome
Timeframe: Day 1, Day 57Population: Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).
All immunogenicity analyses are based on the immunogenicity population.
Outcome measures
| Measure |
H1N1 Monovalent Influenza Vaccine
n=250 Participants
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
Placebo
n=62 Participants
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
|
|---|---|---|
|
Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)
|
7.61 titer
Interval 2.0 to 4096.0
|
3.70 titer
Interval 2.0 to 128.0
|
Adverse Events
H1N1 Monovalent Vaccine Days 1-28
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Days 1-28
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
H1N1 Monvalent Vaccine Days 29-57
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Days 29-57
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
H1N1 Monovalent Vaccine Days 58-209
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Days 58-209
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
H1N1 Monovalent Vaccine Days 1-28
n=259 participants at risk
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
|
Placebo Days 1-28
n=65 participants at risk
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
|
H1N1 Monvalent Vaccine Days 29-57
n=255 participants at risk
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
|
Placebo Days 29-57
n=63 participants at risk
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
|
H1N1 Monovalent Vaccine Days 58-209
n=255 participants at risk；n=259 participants at risk
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
|
Placebo Days 58-209
n=63 participants at risk；n=65 participants at risk
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.39%
1/259 • Number of events 1 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/65 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/259 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/65 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/259 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/65 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.39%
1/255 • Number of events 1 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
Other adverse events
| Measure |
H1N1 Monovalent Vaccine Days 1-28
n=259 participants at risk
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
|
Placebo Days 1-28
n=65 participants at risk
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
|
H1N1 Monvalent Vaccine Days 29-57
n=255 participants at risk
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
|
Placebo Days 29-57
n=63 participants at risk
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
|
H1N1 Monovalent Vaccine Days 58-209
n=255 participants at risk；n=259 participants at risk
MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
|
Placebo Days 58-209
n=63 participants at risk；n=65 participants at risk
Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
1.9%
5/259 • Number of events 6 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
3.1%
2/65 • Number of events 2 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.78%
2/255 • Number of events 3 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
1.6%
1/63 • Number of events 2 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
|
Gastrointestinal disorders
vomiting
|
2.7%
7/259 • Number of events 7 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
2.4%
6/255 • Number of events 6 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
|
Gastrointestinal disorders
diarrhea
|
1.5%
4/259 • Number of events 4 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
2.0%
5/255 • Number of events 5 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/255 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
0.00%
0/63 • Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.
|
Additional Information
Elissa Malkin, D.O.
MedImmune, LLC an affiliate of AstraZeneca AB
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. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER