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Completed

NCT Number: NCT02381418

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

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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 3

Primary location

Research Facility ID ORG-001075

Maroubra, NSW 2035, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Willing and able to give informed consent and able to adhere to all protocol required study procedures.
  • Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
  • Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator

Exclusion criteria

  • Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
  • A serious adverse reaction after a previous (influenza) vaccination.
  • Presence of any significant condition that may prohibit inclusion as determined by the investigator.
  • Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
  • A history of Guillain-Barré syndrome or active neurological disease.

Treatment and study plan

Trivalent influenza subunit vaccine Influvac

Biological

"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "

Primary outcomes

  1. the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.

    Time frame: 3 weeks post vaccination

    Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.

  2. the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.

    Time frame: 3 weeks post vaccination

    Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.

Secondary outcomes

  1. Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.

    Time frame: up to 3 weeks post vaccination

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Southern Hemisphere Season 2015. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 6, 2015
Registry last updated
Dec 22, 2016

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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