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

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza vaccine (split virion, inactivated); Biological: AdimFlu-S

• Registration Number: NCT01752881
• Lead Sponsor: Adimmune Corporation

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2012-12
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Last Update Submitted: 2012-12-17
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AdimFlu-S	Influenza vaccine (split virion, inactivated)	-
AdimFlu-S	AdimFlu-S	-

Primary Outcome Measures

Name	Time	Method
Immunogenicity endpoint: Seroprotection rate	At 3 weeks after vaccination	Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.
Immunogenicity endpoint: Seroconversion rate	At 3 weeks after vaccination	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.
Immunogenicity endpoint: Geometric mean folds increase in HAI titer	At 3 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
Safety: Reactogenicity events	7 days after vaccination	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.
Safety: Serious and non-serious adverse events	Through day 21 post vaccination

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan