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A Randomized Double Blind Parallel-Group Comparative Phase 1/2 Study to Evaluate the Safety and Immunogenicity of a Single Subcutaneous Injection of TAK-850 in Healthy Adult Subjects
The purpose of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in healthy Japanese adults
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 110 |
| Start date | 2014-12 |
| Completion | 2015-01 |
Conditions
- Influenza Infection
Interventions
- Subcutaneous injection of TAK-850
- Intramuscular injection of TAK-850
Primary outcomes
- Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs) — Up to 21 days (Day 22) after vaccination
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. - Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) — Up to 21 days (Day 22) after 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 (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. - Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40. — Day 22 (21 days after vaccination)
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). - Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) — Day 22 (21 days after vaccination)
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). - Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination — Pre-vaccination, 21 Days After vaccination (Day 22)
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.