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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381418
Recruitment Status : Completed
First Posted : March 6, 2015
Results First Posted : December 22, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Influenza Biological: Trivalent influenza subunit vaccine Influvac Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : March 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 1
Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
Biological: Trivalent influenza subunit vaccine Influvac
"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "




Primary Outcome Measures :
  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 Outcome Measures :
  1. Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. [ Time Frame: up to 3 weeks post vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381418


Locations
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Australia
Research Facility ID ORG-001075
Maroubra, Australia, NSW 2035
Sponsors and Collaborators
Abbott
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02381418    
Other Study ID Numbers: INFL3014
First Posted: March 6, 2015    Key Record Dates
Results First Posted: December 22, 2016
Last Update Posted: December 22, 2016
Last Verified: October 2016
Keywords provided by Abbott:
Influenza
Vaccine
Committee for Medicinal Products for Human Use (CHMP) criteria
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases