Trial Outcomes & Findings for A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years (NCT NCT02269475)
NCT ID: NCT02269475
Last Updated: 2017-04-04
Results Overview
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1369 participants
Primary outcome timeframe
through the end of the influenza surveillance period, up to end Apr (6 months)
Results posted on
2017-04-04
Participant Flow
Of the 1369 consented, 68 were excluded after screening.
Participant milestones
| Measure |
MEDI3250
MEDI3250, 0.2mL as nasal spray
|
Placebo
Placebo, 0.2mL as nasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
868
|
433
|
|
Overall Study
Received IP (Safety Population)
|
868
|
433
|
|
Overall Study
Per Protocol Population
|
849
|
430
|
|
Overall Study
COMPLETED
|
865
|
432
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
MEDI3250
MEDI3250, 0.2mL as nasal spray
|
Placebo
Placebo, 0.2mL as nasal spray
|
|---|---|---|
|
Overall Study
Meet Exclusion Criteria No. 17
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years
Baseline characteristics by cohort
| Measure |
MEDI3250
n=868 Participants
MEDI3250, 0.2mL as nasal spray
|
Placebo
n=433 Participants
Placebo, 0.2mL as nasal spray
|
Total
n=1301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.0 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
10.9 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
408 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
634 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
460 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
667 Participants
n=5 Participants
|
|
Number of Doses of Study Vaccine to be Received
1
|
841 Participants
n=5 Participants
|
421 Participants
n=7 Participants
|
1262 Participants
n=5 Participants
|
|
Number of Doses of Study Vaccine to be Received
2
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Prior Influenza Vaccination
Yes
|
788 Participants
n=5 Participants
|
386 Participants
n=7 Participants
|
1174 Participants
n=5 Participants
|
|
Prior Influenza Vaccination
No
|
80 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through the end of the influenza surveillance period, up to end Apr (6 months)Population: Per Protocol Population
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)
Outcome measures
| Measure |
MEDI3250
n=849 Participants
MEDI3250, 0.2mL as nasal spray
|
Placebo
n=430 Participants
Placebo, 0.2mL as nasal spray
|
|---|---|---|
|
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: through the end of the influenza surveillance period, up to end Apr (6 months)The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)
Outcome measures
| Measure |
MEDI3250
n=849 Participants
MEDI3250, 0.2mL as nasal spray
|
Placebo
n=430 Participants
Placebo, 0.2mL as nasal spray
|
|---|---|---|
|
the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)
|
169 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: through the end of the influenza surveillance period, up to end Apr (6 months)Population: Per Protocol Population
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)
Outcome measures
| Measure |
MEDI3250
n=849 Participants
MEDI3250, 0.2mL as nasal spray
|
Placebo
n=430 Participants
Placebo, 0.2mL as nasal spray
|
|---|---|---|
|
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
Strain A_H1N1
|
0 Participants
|
0 Participants
|
|
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
Strain A_H3N2
|
0 Participants
|
0 Participants
|
|
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
Strain B_Yamagata
|
0 Participants
|
1 Participants
|
|
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
Strain B_Victoria
|
0 Participants
|
0 Participants
|
Adverse Events
MEDI3250
Serious events: 3 serious events
Other events: 126 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
Total Number
Serious events: 6 serious events
Other events: 193 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI3250
n=868 participants at risk
MEDI3250, 0.2mL as nasal spray
|
Placebo
n=433 participants at risk
Placebo, 0.2mL as nasal spray
|
Total Number
n=1301 participants at risk
|
|---|---|---|---|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/868 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.23%
1/433 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.08%
1/1301 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Infections and infestations
Appendicitis
|
0.12%
1/868 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.00%
0/433 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.08%
1/1301 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Infections and infestations
Peritonsillar abscess
|
0.12%
1/868 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.00%
0/433 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.08%
1/1301 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Infections and infestations
Pneumonia
|
0.00%
0/868 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.23%
1/433 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.08%
1/1301 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/868 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.23%
1/433 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.08%
1/1301 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Nervous system disorders
Convulsion
|
0.12%
1/868 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.00%
0/433 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.08%
1/1301 • Number of events 1 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
Other adverse events
| Measure |
MEDI3250
n=868 participants at risk
MEDI3250, 0.2mL as nasal spray
|
Placebo
n=433 participants at risk
Placebo, 0.2mL as nasal spray
|
Total Number
n=1301 participants at risk
|
|---|---|---|---|
|
Infections and infestations
nasopharyngitis
|
8.1%
70/868 • Number of events 70 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
8.3%
36/433 • Number of events 36 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
8.1%
106/1301 • Number of events 106 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
1.6%
14/868 • Number of events 14 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
2.1%
9/433 • Number of events 9 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
1.8%
23/1301 • Number of events 23 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract inflammation
|
2.1%
18/868 • Number of events 18 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
1.8%
8/433 • Number of events 8 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
2.0%
26/1301 • Number of events 26 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Infections and infestations
Bronchitis
|
0.58%
5/868 • Number of events 5 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
1.6%
7/433 • Number of events 7 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.92%
12/1301 • Number of events 12 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.0%
9/868 • Number of events 9 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.46%
2/433 • Number of events 2 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
0.85%
11/1301 • Number of events 11 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
10/868 • Number of events 10 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
1.2%
5/433 • Number of events 5 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
1.2%
15/1301 • Number of events 15 • AEs experienced from administration of investigational product through 28 days post last vaccination were collected
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60