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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Trivalent influenza subunit vaccine Influvac

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, Committee for Medicinal Products for Human Use (CHMP) criteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Facility ID ORG-001075

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "

Outcomes

Primary Outcome Measures

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.

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

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02381418

First Posted

March 3, 2015

Last Updated

October 31, 2016

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT02381418

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Vaccine, Committee for Medicinal Products for Human Use (CHMP) criteria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza subunit vaccine Influvac

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

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

Time Frame

3 weeks post vaccination

Title

Description

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

Time Frame

3 weeks post vaccination

Secondary Outcome Measure Information:

Title

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

Time Frame

up to 3 weeks post vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Research Facility ID ORG-001075

City

Maroubra

ZIP/Postal Code

NSW 2035

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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