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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752881
• Other study ID #: FLU12T13A
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2012
• Last updated: December 17, 2012
• Start date: August 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Adimmune Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza vaccine (split virion, inactivated)
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-S

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Adimmune Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity endpoint: Seroprotection rate	Seroprotection rate is defined as the proportion of subjects with HAI titer = 1:40.	At 3 weeks after vaccination	No
Primary	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.	At 3 weeks after vaccination	No
Primary	Immunogenicity endpoint: Geometric mean folds increase in HAI titer		At 3 weeks after vaccination	No
Secondary	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.	7 days after vaccination	Yes
Secondary	Safety: Serious and non-serious adverse events		Through day 21 post vaccination	Yes