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

NCT01752881 | Completed Phase 4

• 1 other identifier: FLU12T13A
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Influenza

Keywords

Influenza; Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (3)

• Immunogenicity endpoint: Seroprotection rate

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

  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.

  At 3 weeks after vaccination

• Immunogenicity endpoint: Geometric mean folds increase in HAI titer

  At 3 weeks after vaccination

Secondary Outcomes (2)

• Safety: Reactogenicity events

  7 days after vaccination

• Safety: Serious and non-serious adverse events

  Through day 21 post vaccination

Study Arms (1)

AdimFlu-S

EXPERIMENTAL

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

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

Also known as: AdimFlu-S Influenza Vaccine

AdimFlu-S

AdimFlu-S BIOLOGICAL

AdimFlu-S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Adimmune Corporation: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Chih-Jen Chang, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 19, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

TW (1)