Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults

July 26, 2013 updated by: Immune Targeting Systems Ltd

A Randomised, Double Blind, Double Observer Study to Assess Repeated Administration of a Single Dose of an Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Dose of a Trivalent Inactivated Influenza Virus Vaccine in Subjects 65 to 74 Years of Age.

This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age, subjects that are more representative of the target population. Both formulations will be administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV) vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 74 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 65 to 74 years inclusive at the time of consent
  • Female subjects will be post-menopausal (no menses for at least 2 years) and therefore of non-child bearing potential
  • Male subjects willing to comply with the applicable contraceptive requirements of the protocol, e.g. must agree to refrain from fathering a child until after the safety follow up visit. Male subjects do not need to use contraception if their partner has been through the menopause, or has had a hysterectomy or bilateral oophorectomy. If a male subject's partner is of child bearing potential, male subjects must agree to use a barrier method (condom) as a method of birth control in addition to any contraceptive measures normally taken by his partner, until after the safety follow up visit.
  • Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation (haematology & biochemistry) as assessed by the Investigator in relation to the age of the patient.
  • An understanding, ability and willingness to fully comply with study procedures and restrictions
  • Ability to provide written, personally signed and dated informed consent to participate in the study.
  • The subject has a BMI < 35.

Exclusion Criteria:

  • As a result of the medical screening process, the Principal Investigator or Co- Investigator considers the subject unfit for the study.
  • Women of child-bearing potential
  • Clinically significant , uncontrolled, current, chronic or recurrent disease, as deemed by the Investigator, (e.g. cardiovascular, respiratory, endocrine, renal, liver, gastrointestinal, autoimmune, immune suppression, malignancy or other conditions) that could affect the action, absorption or disposition of the IMP or could affect clinical or laboratory assessments.
  • Significant illness as judged by the Principal Investigator or Co-Investigator within 2 weeks of the first dose of IMP.
  • Subjects with a history of allergies or allergic conditions including anaphylactic reactions, asthmatics, hay fever, allergy to egg products and eczema sufferers requiring medication which in the opinion of the Principal Investigator or Co- Investigator will affect their participation in the study.
  • Subjects receiving medications that affect the immune system including systemic steroids at a dose greater than 5mg and patients on chronic medications where the dose has not been stable for at least 3 months. Inhaled or topical steroids will be allowed.
  • Known or suspected intolerance or hypersensitivity to the IMP, or closely related compounds or any of the stated ingredients.
  • Male subjects who consume more than 21 units of alcohol per week and female subjects who consume more than 14 units of alcohol per week.
  • A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody screen
  • Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that in the opinion of the Investigator could interfere with evaluation of injection site local reactions, over the deltoid region of both arms as these will be the dose site.
  • Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to or intention to donate blood during the entire study.
  • Use of another investigational medicinal product within 90 days prior to receiving the first dose of IMP or intention to enrol in another clinical study throughout the entire study including the follow up period.
  • Subject with suspected recent (≤6 months) experience of influenza-like illness (fever [>37.8ºC] and cough and/or sore throat > 2 days- in the absence of a known cause other than influenza)
  • Subjects who have received a flu vaccine in the last 6 months
  • Any clinically significant abnormalities, in the opinion of the Principal Investigator or Co-Investigator, on electrocardiograms (ECGs)
  • In addition, for each subject, a completed medical history questionnaire will be taken as part of the consented study procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1
Day 1: FP-01.1 + Placebo ; Day 29: FP-01.1
Biological: FP-01.1 + Placebo
Biological: FP-01.1
Active Comparator: Group 2
Day 1: FP-01.1 + TIV ; Day 29: FP-01.1
Biological: FP-01.1
Biological: FP-01.1 + TIV
Active Comparator: Group 3
Day 1: FP-01.1-Adjuvant + Placebo ; Day 29: FP-01.1-Adjuvant
Biological: FP-01.1-Adjuvant + Placebo
Biological: FP-01.1-Adjuvant
Active Comparator: Group 4
Day 1: FP-01.1-Adjuvant + TIV ; Day 29: FP-01.1-Adjuvant
Biological: FP-01.1-Adjuvant
Biological: FP-01.1-Adjuvant + TIV
Active Comparator: Group 5
Day 1: Adjuvant + TIV ; Day 29: Placebo
Other: Placebo
Biological: Adjuvant + TIV
Active Comparator: Group 6
Day 1: Placebo + TIV ; Day 29: Placebo
Other: Placebo
Biological: Placebo + TIV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
Time Frame: Day 1- 209
Day 1- 209
To assess and compare the immunogenicity response between groups
Time Frame: Day 1- 209
The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group
Day 1- 209
Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)
Time Frame: Day 1- 209
Day 1- 209
Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
Time Frame: Day 1- 209
Day 1- 209
Number and proportion of subjects with abnormal vital signs/ECG assessments
Time Frame: Day 1 - 209
Day 1 - 209

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Exploratory immunogenicity tests on samples obtained from subjects
Time Frame: Day 1 -209
Day 1 -209
To assess the impact of FP-01.1 and FP-01.1-Adjuvant on the immune response to TIV
Time Frame: Day 1-209
Day 1-209

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immune Targeting Systems Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Geert Leroux-Roels, Professor, Centre for Vaccinology, Ghent University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FP-01.1_CS_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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