Who is sponsoring NCT02555618?

NCT02555618 is sponsored by Takeda.

What condition does NCT02555618 study?

NCT02555618 studies Influenza Infection.

What drugs are being tested in NCT02555618?

Interventions: TAK-850, Influenza HA vaccine.

What is the status of NCT02555618?

NCT02555618 is currently COMPLETED.

Last reviewed 2016-11-02 · How we verify

A Randomized Double-Blind Parallel-Group Comparative Phase 2 Study to Evaluate the Immunogenicity and Safety of a Single Subcutaneous Injection of TAK-850 in Comparison With Influenza HA Vaccine in Healthy Adult Subjects

NCT02555618 Phase 2 COMPLETED Results posted

The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.

Details

Lead sponsor	Takeda
Phase	Phase 2
Status	COMPLETED
Enrolment	400
Start date	2015-09
Completion	2015-12

Conditions

Influenza Infection

Interventions

TAK-850
Influenza HA vaccine

Primary outcomes

Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) — Baseline and Day 22
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) — Days 1 and 22
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.