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OpenTrials
Completed

NCT Number: NCT01752881

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

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).

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Other names: AdimFlu-S Influenza Vaccine

AdimFlu-S

Biological

Primary outcomes

  1. Immunogenicity endpoint: Seroprotection rate

    Time frame: At 3 weeks after vaccination

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

  2. Immunogenicity endpoint: Seroconversion rate

    Time frame: 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.

  3. Immunogenicity endpoint: Geometric mean folds increase in HAI titer

    Time frame: At 3 weeks after vaccination

Secondary outcomes

  1. Safety: Reactogenicity events

    Time frame: 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.

  2. Safety: Serious and non-serious adverse events

    Time frame: Through day 21 post vaccination

Sponsors and collaborators

Lead sponsor

Adimmune Corporation

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2012
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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