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

Purpose

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).

Condition	Intervention	Phase
Influenza	Biological: Influenza vaccine (split virion, inactivated) Biological: AdimFlu-S	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Adimmune Corporation:

Primary Outcome Measures:

Immunogenicity endpoint: Seroprotection rate [ Time Frame: At 3 weeks after vaccination ] [ Designated as safety issue: No ]
Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.
Immunogenicity endpoint: Seroconversion rate [ Time Frame: At 3 weeks after vaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: At 3 weeks after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Reactogenicity events [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Through day 21 post vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	130
Study Start Date:	August 2012
Study Completion Date:	September 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AdimFlu-S	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 Other Name: AdimFlu-S Influenza Vaccine Biological: AdimFlu-S

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752881

Locations

Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan

Sponsors and Collaborators

Adimmune Corporation

Investigators

Principal Investigator:

Chih-Jen Chang, MD

National Cheng-Kung University Hospital

More Information

No publications provided

Responsible Party:	Adimmune Corporation
ClinicalTrials.gov Identifier:	NCT01752881 History of Changes
Other Study ID Numbers:	FLU12T13A
Study First Received:	December 17, 2012
Last Updated:	December 17, 2012
Health Authority:	Taiwan : Food and Drug Administration

Keywords provided by Adimmune Corporation:

Influenza
Vaccine
Immunogenicity

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013