Trial Outcomes & Findings for Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants (NCT NCT02367885)
NCT ID: NCT02367885
Last Updated: 2016-04-07
Results Overview
Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Up to 21 days after any vaccination
Results posted on
2016-04-07
Participant Flow
Participants took part in the study at 2 investigative sites in Japan from 14 February 2015 to 2 May 2015.
Healthy pediatric participants of age group 6 months-19 years were enrolled in 1 of the 3 treatment groups: TAK-850 0.25 milliliter (mL): 6 - 35 months; TAK-850 0.5 mL: 3-12 Years and TAK-850 0.5 mL: 13-19 Years.
Participant milestones
| Measure |
TAK-850 0.25 mL: 6-35 Months
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 3-12 Years
Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
31
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
TAK-850 0.25 mL: 6-35 Months
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 3-12 Years
Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants
Baseline characteristics by cohort
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 3-12 Years
n=33 Participants
Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
6-35 Months
|
33 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
33 participants
n=7 Participants
|
|
Age, Customized
3-12 Years
|
0 participants
n=99 Participants
|
33 participants
n=107 Participants
|
0 participants
n=206 Participants
|
33 participants
n=7 Participants
|
|
Age, Customized
13-19 Years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
33 participants
n=206 Participants
|
33 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
33 participants
n=99 Participants
|
33 participants
n=107 Participants
|
33 participants
n=206 Participants
|
99 participants
n=7 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 Titer at Day 1(Pre-vaccination)
Less Than (<) 40 Titer
|
31 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
51 participants
n=7 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - A/H1N1 Titer at Day 1(Pre-vaccination)
Greater Than or Equal to (>=) 40 Titer
|
2 participants
n=99 Participants
|
27 participants
n=107 Participants
|
19 participants
n=206 Participants
|
48 participants
n=7 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - A/H3N2 Titer at Day 1 (Pre-vaccination)
<40 Titer
|
26 participants
n=99 Participants
|
16 participants
n=107 Participants
|
15 participants
n=206 Participants
|
57 participants
n=7 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - A/H3N2 Titer at Day 1 (Pre-vaccination)
>=40 Titer
|
7 participants
n=99 Participants
|
17 participants
n=107 Participants
|
18 participants
n=206 Participants
|
42 participants
n=7 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - B Titer at Day 1 (Pre-vaccination)
<40 Titer
|
33 participants
n=99 Participants
|
33 participants
n=107 Participants
|
26 participants
n=206 Participants
|
92 participants
n=7 Participants
|
|
Hemagglutination Inhibition (HI) (Egg-derived) - B Titer at Day 1 (Pre-vaccination)
>=40 Titer
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
7 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Influenza Infection within 5 years
Infection occurred
|
2 participants
n=99 Participants
|
16 participants
n=107 Participants
|
7 participants
n=206 Participants
|
25 participants
n=7 Participants
|
|
Influenza Infection within 5 years
Infection did not occur
|
31 participants
n=99 Participants
|
17 participants
n=107 Participants
|
26 participants
n=206 Participants
|
74 participants
n=7 Participants
|
|
Administration of Antipyretics
Antipyretics administered
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Administration of Antipyretics
Antipyretics not administered
|
31 participants
n=99 Participants
|
32 participants
n=107 Participants
|
32 participants
n=206 Participants
|
95 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days after any vaccinationPopulation: Safety analysis set included all participants who received at least 1 dose of study vaccination.
Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Injection site tenderness
|
3 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Injection site ecchymosis
|
4 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Pyrexia
|
12 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Sweaty
|
2 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Vomiting
|
6 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Irritability postvaccinal
|
2 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Crying abnormal
|
2 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Inappetence
|
3 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Somnolence
|
5 participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
Sleeplessness
|
2 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 days after any vaccinationPopulation: Safety analysis set included all participants who received at least 1 dose of study vaccination.
Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Vomiting
|
2 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Injection site pain
|
19 participants
|
8 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Injection site redness
|
6 participants
|
1 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Injection site swelling
|
6 participants
|
3 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Injection site induration
|
3 participants
|
2 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Injection site tenderness
|
23 participants
|
18 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Injection site ecchymosis
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Pyrexia
|
3 participants
|
1 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Malaise
|
5 participants
|
3 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Chills
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Fatigue
|
4 participants
|
2 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Headache
|
1 participants
|
1 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Sweaty
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Myalgia
|
3 participants
|
1 participants
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
Nausea
|
0 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Up to 21 days after any vaccinationPopulation: Safety analysis set included all participants who received at least 1 dose of study vaccination.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
AEs
|
24 participants
|
29 participants
|
24 participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 22 (21 days after Vaccination)Population: All participants included in the full analysis set (FAS) (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group
A/H1N1 Strain
|
97.0 percentage of participants
Interval 84.241 to 99.923
|
—
|
—
|
|
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group
A/H3N2 Strain
|
93.9 percentage of participants
Interval 79.774 to 99.257
|
—
|
—
|
|
Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group
B Strain
|
66.7 percentage of participants
Interval 48.173 to 82.039
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 43 (21 days after Vaccination 2)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
B Strain (n=31, 31)
|
9.7 percentage of participants
Interval 2.042 to 25.754
|
45.2 percentage of participants
Interval 27.316 to 63.966
|
—
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H1N1 Strain (n=31, 31)
|
87.1 percentage of participants
Interval 70.166 to 96.37
|
100 percentage of participants
Interval 88.781 to 100.0
|
—
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H3N2 Strain (n=31, 31)
|
71.0 percentage of participants
Interval 51.964 to 85.777
|
90.3 percentage of participants
Interval 74.246 to 97.958
|
—
|
PRIMARY outcome
Timeframe: Day 22 (21 days after Vaccination)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group
A/H1N1 Strain
|
66.7 percentage of participants
Interval 48.173 to 82.039
|
—
|
—
|
|
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group
A/H3N2 Strain
|
45.5 percentage of participants
Interval 28.107 to 63.649
|
—
|
—
|
|
Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group
B Strain
|
45.5 percentage of participants
Interval 28.107 to 63.649
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 43 (21 days after Vaccination 2)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H3N2 Strain (n=31, 31)
|
58.1 percentage of participants
Interval 39.076 to 75.452
|
54.8 percentage of participants
Interval 36.034 to 72.684
|
—
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H1N1 Strain (n=31, 31)
|
80.6 percentage of participants
Interval 62.527 to 92.548
|
71.0 percentage of participants
Interval 51.964 to 85.777
|
—
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
B Strain (n=31, 31)
|
9.7 percentage of participants
Interval 2.042 to 25.754
|
45.2 percentage of participants
Interval 27.316 to 63.966
|
—
|
PRIMARY outcome
Timeframe: Day 22 (21 days after Vaccination)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group
A/H1N1 Strain
|
13.53 fold increase
Interval 6.34 to 28.852
|
—
|
—
|
|
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group
A/H3N2 Strain
|
3.66 fold increase
Interval 2.212 to 6.05
|
—
|
—
|
|
Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group
B Strain
|
3.68 fold increase
Interval 2.374 to 5.698
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 43 (21 days after Vaccination 2)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H1N1 Strain (n=31, 31)
|
14.23 fold increase
Interval 8.856 to 22.857
|
6.15 fold increase
Interval 4.076 to 9.284
|
—
|
|
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H3N2 Strain (n=31, 31)
|
5.85 fold increase
Interval 3.728 to 9.183
|
4.73 fold increase
Interval 2.882 to 7.764
|
—
|
|
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
B Strain (n=31, 31)
|
1.32 fold increase
Interval 0.958 to 1.825
|
2.86 fold increase
Interval 1.823 to 4.489
|
—
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group
B Strain (n=32, 32)
|
6.3 percentage of participants
Interval 0.766 to 20.807
|
46.9 percentage of participants
Interval 29.094 to 65.256
|
—
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group
A/H1N1 Strain (n=32, 32)
|
15.6 percentage of participants
Interval 5.275 to 32.788
|
93.8 percentage of participants
Interval 79.193 to 99.234
|
—
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group
A/H3N2 Strain (n=32, 32)
|
28.1 percentage of participants
Interval 13.746 to 46.747
|
75.0 percentage of participants
Interval 56.595 to 88.538
|
—
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H1N1 Strain (n=32, 32)
|
9.4 percentage of participants
Interval 1.977 to 25.023
|
53.1 percentage of participants
Interval 34.744 to 70.906
|
—
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H3N2 Strain (n=32, 32)
|
15.6 percentage of participants
Interval 5.275 to 32.788
|
37.5 percentage of participants
Interval 21.1 to 56.308
|
—
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
B Strain (n=32, 32)
|
6.3 percentage of participants
Interval 0.766 to 20.807
|
46.9 percentage of participants
Interval 29.094 to 65.256
|
—
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.
GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H1N1 Strain (n=32, 32)
|
1.41 fold increase
Interval 1.059 to 1.888
|
5.36 fold increase
Interval 3.221 to 8.916
|
—
|
|
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
A/H3N2 Strain (n=32, 32)
|
1.58 fold increase
Interval 1.158 to 2.145
|
3.15 fold increase
Interval 2.02 to 4.917
|
—
|
|
GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
B Strain (n=32, 32)
|
1.22 fold increase
Interval 0.907 to 1.628
|
3.22 fold increase
Interval 1.972 to 5.26
|
—
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in FAS (all participants who received at least 1 dose of study vaccination) who had available data for specified strain at specified post-baseline time points.
GMT of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H1N1: 21 days after Vaccination 1 (n=32,32,33)
|
8.78 titer
Interval 5.872 to 13.132
|
583.71 titer
Interval 351.985 to 967.995
|
558.32 titer
Interval 391.258 to 796.705
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H1N1: 21 days after Vaccination 2 (n=31,31, 0)
|
88.96 titer
Interval 57.072 to 138.677
|
773.95 titer
Interval 576.157 to 1039.645
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H3N2: 21 days after Vaccination 1 (n=32,32,33)
|
17.56 titer
Interval 9.046 to 34.086
|
87.24 titer
Interval 47.894 to 158.908
|
133.14 titer
Interval 86.409 to 205.133
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
B: 21 days after Vaccination 1 (n=32,32,33)
|
6.08 titer
Interval 4.535 to 8.141
|
16.82 titer
Interval 10.192 to 27.751
|
28.58 titer
Interval 18.421 to 44.351
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
A/H3N2: 21 days after Vaccination 2 (n=31,31, 0)
|
66.90 titer
Interval 38.136 to 117.347
|
127.94 titer
Interval 76.82 to 213.092
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
B: 21 days after Vaccination 2 (n=31,31,0)
|
6.61 titer
Interval 4.79 to 9.127
|
14.96 titer
Interval 9.4 to 23.792
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of \>=25 mm\^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0)
|
79.3 percentage of participants
Interval 60.275 to 92.006
|
93.5 percentage of participants
Interval 78.578 to 99.209
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
15.6 percentage of participants
Interval 5.275 to 32.788
|
78.1 percentage of participants
Interval 60.027 to 90.723
|
97.0 percentage of participants
Interval 84.241 to 99.923
|
|
Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
9.4 percentage of participants
Interval 1.977 to 25.023
|
90.6 percentage of participants
Interval 74.977 to 98.023
|
100 percentage of participants
Interval 89.424 to 100.0
|
|
Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0)
|
79.3 percentage of participants
Interval 60.275 to 92.006
|
100 percentage of participants
Interval 88.781 to 100.0
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
28.1 percentage of participants
Interval 13.746 to 46.747
|
78.1 percentage of participants
Interval 60.027 to 90.723
|
97.0 percentage of participants
Interval 84.241 to 99.923
|
|
Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
B: 21 days after Vaccination 2 (n=29, 31, 0)
|
48.3 percentage of participants
Interval 29.449 to 67.469
|
87.1 percentage of participants
Interval 70.166 to 96.37
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of \>4 mm\^2) or achieving a SRH antibody titer of \>=25 mm\^2 (with baseline SRH antibody titer of \<=4 mm\^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1: 21 days after Vaccination 1 (n=32,32,33)
|
6.3 percentage of participants
Interval 0.766 to 20.807
|
81.3 percentage of participants
Interval 63.561 to 92.792
|
72.7 percentage of participants
Interval 54.476 to 86.7
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
B: 21 days after Vaccination 2 (n=29,31,0)
|
48.3 percentage of participants
Interval 29.449 to 67.469
|
74.2 percentage of participants
Interval 55.387 to 88.144
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1: 21 days after Vaccination 2 (n=29,31,0)
|
79.3 percentage of participants
Interval 60.275 to 92.006
|
90.3 percentage of participants
Interval 74.246 to 97.958
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2: 21 days after Vaccination 1 (n=32,32,33)
|
18.8 percentage of participants
Interval 7.208 to 36.439
|
46.9 percentage of participants
Interval 29.094 to 65.256
|
42.4 percentage of participants
Interval 25.476 to 60.785
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2: 21 days after Vaccination 2 (n=29,31,0)
|
69.0 percentage of participants
Interval 49.168 to 84.715
|
67.7 percentage of participants
Interval 48.627 to 83.318
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
B: 21 days after Vaccination 1 (n=32,32, 33)
|
15.6 percentage of participants
Interval 5.275 to 32.788
|
62.5 percentage of participants
Interval 43.692 to 78.9
|
42.4 percentage of participants
Interval 25.476 to 60.785
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.2020 fold increase
Interval 0.98289 to 1.46989
|
2.4707 fold increase
Interval 1.89898 to 3.21447
|
2.7540 fold increase
Interval 1.97811 to 3.8343
|
|
GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0)
|
7.0652 fold increase
Interval 4.91411 to 10.15793
|
2.9292 fold increase
Interval 2.23349 to 3.84174
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.5038 fold increase
Interval 1.1804 to 1.91588
|
1.9682 fold increase
Interval 1.5752 to 2.45935
|
2.0612 fold increase
Interval 1.51354 to 2.80709
|
|
GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0)
|
5.1163 fold increase
Interval 3.65073 to 7.17028
|
2.3363 fold increase
Interval 1.77098 to 3.08201
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.3443 fold increase
Interval 1.03252 to 1.75027
|
2.8400 fold increase
Interval 1.98458 to 4.06424
|
1.8889 fold increase
Interval 1.4242 to 2.50523
|
|
GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
B:21 days after Vaccination 2 (n=29, 31, 0)
|
3.7658 fold increase
Interval 2.666 to 5.31917
|
3.8880 fold increase
Interval 2.72038 to 5.55686
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
6.3066 titer
Interval 4.34309 to 9.15778
|
41.4710 titer
Interval 29.47979 to 58.33961
|
70.2017 titer
Interval 58.66371 to 84.00902
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0)
|
30.5555 titer
Interval 21.5043 to 43.41647
|
83.8136 titer
Interval 74.30566 to 94.53822
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
5.1604 titer
Interval 4.0158 to 6.63117
|
64.4700 titer
Interval 45.99985 to 90.35654
|
89.8328 titer
Interval 82.79308 to 97.47116
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
9.8918 titer
Interval 6.28974 to 15.55675
|
36.4508 titer
Interval 26.86516 to 49.45654
|
52.9301 titer
Interval 46.41297 to 60.36242
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0)
|
33.0272 titer
Interval 24.40664 to 44.6926
|
46.7134 titer
Interval 37.50756 to 58.17885
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMT of SRH Antibody Titer (Egg-Derived Antigen)
B: 21 days after Vaccination 2 (n=29, 31, 0)
|
16.9727 titer
Interval 11.6629 to 24.69991
|
52.8247 titer
Interval 44.14357 to 63.21315
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0)
|
32.3 percentage of participants
Interval 16.682 to 51.373
|
93.5 percentage of participants
Interval 78.578 to 99.209
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
28.1 percentage of participants
Interval 13.746 to 46.747
|
81.3 percentage of participants
Interval 63.561 to 92.792
|
97.0 percentage of participants
Interval 84.241 to 99.923
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
A/H3N2: 21 days after Vaccination 2 (n=31,31, 0)
|
74.2 percentage of participants
Interval 55.387 to 88.144
|
87.1 percentage of participants
Interval 70.166 to 96.37
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
B: 21 days after Vaccination 2 (n=31, 31, 0)
|
9.7 percentage of participants
Interval 2.042 to 25.754
|
51.6 percentage of participants
Interval 33.061 to 69.845
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
3.1 percentage of participants
Interval 0.079 to 16.217
|
90.6 percentage of participants
Interval 74.977 to 98.023
|
90.9 percentage of participants
Interval 75.668 to 98.085
|
|
Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
9.4 percentage of participants
Interval 1.977 to 25.023
|
34.4 percentage of participants
Interval 18.572 to 53.193
|
48.5 percentage of participants
Interval 30.796 to 66.456
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
0.0 percentage of participants
Interval 0.0 to 10.888
|
78.1 percentage of participants
Interval 60.027 to 90.723
|
69.7 percentage of participants
Interval 51.289 to 84.408
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0)
|
32.3 percentage of participants
Interval 16.682 to 51.373
|
87.1 percentage of participants
Interval 70.166 to 96.37
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 2 (n=31,31, 0)
|
67.7 percentage of participants
Interval 48.627 to 83.318
|
54.8 percentage of participants
Interval 36.034 to 72.684
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
9.4 percentage of participants
Interval 1.977 to 25.023
|
28.1 percentage of participants
Interval 13.746 to 46.747
|
42.4 percentage of participants
Interval 25.476 to 60.785
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 2 (n=31, 31, 0)
|
9.7 percentage of participants
Interval 2.042 to 25.754
|
48.4 percentage of participants
Interval 30.155 to 66.939
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
21.9 percentage of participants
Interval 9.277 to 39.973
|
43.8 percentage of participants
Interval 26.364 to 62.337
|
42.4 percentage of participants
Interval 25.476 to 60.785
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.02 fold increase
Interval 0.978 to 1.068
|
16.17 fold increase
Interval 9.606 to 27.233
|
7.51 fold increase
Interval 4.8 to 11.754
|
|
GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.27 fold increase
Interval 0.965 to 1.669
|
2.62 fold increase
Interval 1.695 to 4.055
|
3.21 fold increase
Interval 2.13 to 4.833
|
|
GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0)
|
2.30 fold increase
Interval 1.472 to 3.592
|
17.30 fold increase
Interval 10.589 to 28.268
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.72 fold increase
Interval 1.264 to 2.338
|
3.67 fold increase
Interval 2.25 to 5.979
|
3.90 fold increase
Interval 2.387 to 6.361
|
|
GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0)
|
6.40 fold increase
Interval 4.11 to 9.954
|
4.78 fold increase
Interval 2.937 to 7.791
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
B: 21 days after Vaccination 2 (n=31, 31, 0)
|
1.28 fold increase
Interval 0.964 to 1.697
|
2.99 fold increase
Interval 1.918 to 4.663
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMT of HI Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 2 (n=31, 31, 0)
|
6.39 titer
Interval 4.819 to 8.483
|
17.49 titer
Interval 10.923 to 28.003
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMT of HI Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
5.34 titer
Interval 4.673 to 6.092
|
156.57 titer
Interval 99.959 to 245.257
|
69.79 titer
Interval 49.992 to 97.43
|
|
GMT of HI Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 2 (n=31, 31, 0)
|
12.03 titer
Interval 7.571 to 19.101
|
187.11 titer
Interval 123.079 to 284.443
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMT of HI Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
16.46 titer
Interval 8.314 to 32.578
|
94.11 titer
Interval 50.943 to 173.861
|
141.80 titer
Interval 102.494 to 196.169
|
|
GMT of HI Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 2 (n=31, 31, 0)
|
62.55 titer
Interval 34.861 to 112.233
|
143.08 titer
Interval 79.875 to 256.286
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMT of HI Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
6.35 titer
Interval 4.825 to 8.344
|
15.26 titer
Interval 9.688 to 24.026
|
19.38 titer
Interval 12.917 to 29.076
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of \>=25 mm\^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
0.0 percentage of participants
Interval 0.0 to 10.888
|
75.0 percentage of participants
Interval 56.595 to 88.538
|
81.8 percentage of participants
Interval 64.54 to 93.021
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0)
|
10.3 percentage of participants
Interval 2.186 to 27.352
|
87.1 percentage of participants
Interval 70.166 to 96.37
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0)
|
86.2 percentage of participants
Interval 68.336 to 96.111
|
96.8 percentage of participants
Interval 83.298 to 99.918
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
15.6 percentage of participants
Interval 5.275 to 32.788
|
71.9 percentage of participants
Interval 53.253 to 86.254
|
81.8 percentage of participants
Interval 64.54 to 93.021
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
B: 21 days after Vaccination 2 (n=29, 31, 0)
|
27.6 percentage of participants
Interval 12.734 to 47.238
|
83.9 percentage of participants
Interval 66.273 to 94.548
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
34.4 percentage of participants
Interval 18.572 to 53.193
|
90.6 percentage of participants
Interval 74.977 to 98.023
|
97.0 percentage of participants
Interval 84.241 to 99.923
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of \>4 mm\^2), or achieving a SRH antibody titer of \>=25 mm\^2 (with baseline SRH antibody titer of \<=4 mm\^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
0.0 percentage of participants
Interval 0.0 to 10.888
|
75.0 percentage of participants
Interval 56.595 to 88.538
|
54.5 percentage of participants
Interval 36.351 to 71.893
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0)
|
10.3 percentage of participants
Interval 2.186 to 27.352
|
87.1 percentage of participants
Interval 70.166 to 96.37
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
18.8 percentage of participants
Interval 7.208 to 36.439
|
40.6 percentage of participants
Interval 23.698 to 59.355
|
51.5 percentage of participants
Interval 33.544 to 69.204
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0)
|
72.4 percentage of participants
Interval 52.762 to 87.266
|
58.1 percentage of participants
Interval 39.076 to 75.452
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
12.5 percentage of participants
Interval 3.513 to 28.995
|
56.3 percentage of participants
Interval 37.663 to 73.636
|
57.6 percentage of participants
Interval 39.215 to 74.524
|
|
Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 2 (n=29, 31, 0)
|
24.1 percentage of participants
Interval 10.298 to 43.54
|
64.5 percentage of participants
Interval 45.37 to 80.773
|
NA percentage of participants
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.0000 fold increase
95% confidence interval was not calculable because SRH antibody titers of Pre-vaccination and Post-vaccinations in all participants were same.
|
3.8815 fold increase
Interval 2.91105 to 5.17543
|
3.0063 fold increase
Interval 2.0669 to 4.3727
|
|
GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
1.4480 fold increase
Interval 1.18483 to 1.76972
|
1.7522 fold increase
Interval 1.41051 to 2.17678
|
2.0947 fold increase
Interval 1.57731 to 2.78168
|
|
GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0)
|
4.9597 fold increase
Interval 3.52649 to 6.97548
|
2.2506 fold increase
Interval 1.67926 to 3.01629
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
B: 21 days after Vaccination 1 (n= 32, 32, 33)
|
1.2209 fold increase
Interval 0.97777 to 1.52445
|
3.6157 fold increase
Interval 2.38627 to 5.47866
|
2.6846 fold increase
Interval 1.92487 to 3.74409
|
|
GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
B:21 days after Vaccination 2 (n= 29, 31, 0)
|
2.2979 fold increase
Interval 1.59954 to 3.30117
|
4.4759 fold increase
Interval 3.05031 to 6.56777
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0)
|
1.2706 fold increase
Interval 0.99257 to 1.62639
|
4.1427 fold increase
Interval 3.11949 to 5.50159
|
NA fold increase
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
SECONDARY outcome
Timeframe: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)Population: All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.
GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.
Outcome measures
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 Participants
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 Participants
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
GMT of SRH Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 1 (n=32, 32, 33)
|
4.0000 titer
95% confidence interval was not calculable because SRH antibody titers of Pre-vaccination and Post-vaccinations in all participants were same.
|
26.8737 titer
Interval 20.52041 to 35.19414
|
32.3664 titer
Interval 25.74333 to 40.69349
|
|
GMT of SRH Antibody Titer (Vero Antigen)
A/H1N1: 21 days after Vaccination 2 (n=29, 31, 0)
|
5.0822 titer
Interval 3.97027 to 6.50558
|
30.9216 titer
Interval 24.14566 to 39.59911
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMT of SRH Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 1 (n=32, 32, 33)
|
12.2879 titer
Interval 8.09586 to 18.65065
|
40.3869 titer
Interval 31.13697 to 52.38484
|
61.7091 titer
Interval 53.35048 to 71.37721
|
|
GMT of SRH Antibody Titer (Vero Antigen)
A/H3N2: 21 days after Vaccination 2 (n=29, 31, 0)
|
40.4564 titer
Interval 32.1985 to 50.83224
|
55.3238 titer
Interval 48.82904 to 62.68238
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
|
GMT of SRH Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 1 (n=32, 32, 33)
|
6.5038 titer
Interval 4.44742 to 9.51111
|
35.8443 titer
Interval 25.16079 to 51.06422
|
38.2075 titer
Interval 29.71344 to 49.12974
|
|
GMT of SRH Antibody Titer (Vero Antigen)
B: 21 days after Vaccination 2 (n=29, 31, 0)
|
10.8420 titer
Interval 7.20922 to 16.3054
|
44.8583 titer
Interval 36.23158 to 55.53899
|
NA titer
Data is not required for this age group because Vaccination 2 is not planned for 13-19 years old group.
|
Adverse Events
TAK-850 0.25 mL: 6-35 Months
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
TAK-850 0.5 mL: 3-12 Years
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
TAK-850 0.5 mL: 13-19 Years
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 participants at risk
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 3-12 Years
n=33 participants at risk
Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 participants at risk
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
TAK-850 0.25 mL: 6-35 Months
n=33 participants at risk
Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram \[mcg\]/0.5 mL of hemagglutinin \[HA\] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 3-12 Years
n=33 participants at risk
Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
|
TAK-850 0.5 mL: 13-19 Years
n=33 participants at risk
Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
|
|---|---|---|---|
|
Eye disorders
Eye discharge
|
12.1%
4/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
6/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pain
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
72.7%
24/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
57.6%
19/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
36.4%
12/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site swelling
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
6/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.2%
5/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
6/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.1%
4/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site haemorrhage
|
12.1%
4/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site induration
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pruritus
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.1%
4/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site warmth
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.1%
4/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Crying
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Irritability postvaccinal
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Molluscum contagiosum
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
15.2%
5/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
27.3%
9/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.1%
4/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
18.2%
6/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.1%
2/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • TAEs are AEs, regardless of relationship to drug, that occur or worsen after first dose of study vaccine and no more than 21 days after the last dose (up to Day 43 for 6-35 months old group and 3-12 years old group, up to Day 22 for 13-19 years old group)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER