Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02555618 | Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants | PHASE2 | COMPLETED | 400 | — | — | Sep 1, 2015 | Dec 1, 2015 | Dec 29, 2016 | - | — |
| NCT02367885 | Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants | PHASE1 | COMPLETED | 99 | — | — | Feb 1, 2015 | May 1, 2015 | Apr 7, 2016 | 2 | Japan |
| NCT02313155 | Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults | PHASE1 | COMPLETED | 110 | — | — | Dec 1, 2014 | Jan 1, 2015 | Feb 17, 2016 | - | — |
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10.
Geometric mean titer (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 vaccination. Day 1 data is reported for reference.
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.
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.
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.
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.
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.
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).
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).
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.
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.
Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.
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 (eg, 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.
Seroprotection rate as measured by HI antibody titer (egg-derived antigen) was defined as percentage of participants with the HI antibody titer of \>=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
Seroconversion rate as measured by the HI antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline \>=10) or achieving an HI antibody titer of \>=40 (baseline \<10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).
GMFI in HI antibody titer (egg-derived antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.
| Arm | Type | Description |
|---|---|---|
| TAK-850 | EXPERIMENTAL | A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \[HA\] antigen per strain) is injected subcutaneously into the upper arm. |
| Influenza HA Vaccine | ACTIVE_COMPARATOR | A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. |
| TAK-850 0.5 mL injection (13-19 years of age) | EXPERIMENTAL | Single intramuscular injection of TAK-850 0.5 mL in participants aged 13-19 years |
| TAK-850 0.5 mL injection (3-12 years of age) | EXPERIMENTAL | Two intramuscular injections of TAK-850 0.5 mL in participants aged 3-12 years old. |
| TAK-850 0.25 mL injection (6-35 months of age) | EXPERIMENTAL | Two intramuscular injections of TAK-850 0.25 mL in participants aged 6-35 months old. |
| TAK-850 0.5 mL (subcutaneous) | EXPERIMENTAL | Single subcutaneous injection of TAK-850 |
| TAK-850 0.5 mL (Intramuscular) | EXPERIMENTAL | Single intramuscular injection of TAK-850 |
| Name | Type | Description |
|---|---|---|
| TAK-850 | BIOLOGICAL | TAK-850 subcutaneous injection |
| Influenza HA vaccine | BIOLOGICAL | Influenza HA vaccine subcutaneous injection |
| TAK-850 0.5 mL injection | DRUG | TAK-850 injection |
| TAK-850 0.25 mL injection | DRUG | TAK-850 intramuscular injection |
| Subcutaneous injection of TAK-850 | DRUG | TAK-850 0.5 mL, Subcutaneous injection |
| Intramuscular injection of TAK-850 | DRUG | TAK-850 0.5 mL, Intramuscular injection |
Inclusion Criteria: 1. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3. The participant...