Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

Adimmune Corporation130 enrolled

Overview

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

130

Conditions

Influenza

Interventions

Influenza vaccine (split virion, inactivated)BIOLOGICAL

AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013 Dosage: 0.5mL/per syringe Administration route: Intramuscular Injection, once

AdimFlu-SBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males or non-pregnant females and aged ≥ 18 years; * Willing and able to adhere to visit schedules and all study requirements; * Subjects read and signed the study-specific informed consent. Exclusion Criteria: \-

Locations (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Outcomes

Primary Outcomes

Immunogenicity endpoint: Seroprotection rate

Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.

Time frame: At 3 weeks after vaccination

Immunogenicity endpoint: Seroconversion rate

The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer \< 1:10.

Time frame: At 3 weeks after vaccination

Immunogenicity endpoint: Geometric mean folds increase in HAI titer

Time frame: At 3 weeks after vaccination

Secondary Outcomes

Safety: Reactogenicity events

Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection including fever (≥38°C), runny nose or nasal congestion, cough, sore throat, headache, muscle aches, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions will also be evaluated that include soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.

Time frame: 7 days after vaccination

Safety: Serious and non-serious adverse events

Time frame: Through day 21 post vaccination

Data from ClinicalTrials.gov

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