## Protocol Section
### Identification Module
**NCT ID:** NCT01389479

**Brief Title:** Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ in Healthy Adults

**Official Title:** Active-control Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ S/F Influenza Vaccine in Healthy Adults Aged 18-64 Years of Age

#### Organization Study ID Info
**ID:** IDB-707-105
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2005-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-06-08

**Type:** ACTUAL

**Last Update Submit Date:** 2017-06-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-05

**Type:** ACTUAL

#### Start Date
**Date:** 2005-01

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2011-07-08
**Type:** ESTIMATED
**Study First Submit Date:** 2011-07-04
**Study First Submit QC Date:** 2011-07-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** ID Biomedical Corporation, Quebec

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™ in healthy adults aged 18-64 years.

**Detailed Description:** This study was conducted by ID BioMedical which has been taken over by GlaxoSmithKline. At the time of conduct of this study, Fluviral was produced by ID BioMedical.

### Conditions Module

**Conditions:**

- Influenza

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1000

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: Fluviral™

**Label:** Fluviral Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Biological: Fluzone®

**Label:** Fluzone Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fluviral Group

**Description:** Intramuscular, single dose

**Name:** Fluviral™

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Fluzone Group

**Description:** Intramuscular, single dose

**Name:** Fluzone®

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of subjects with solicited local and systemic reactogenicity symptoms

**Time Frame:** First three days after vaccination

**Measure:** Number of subjects reporting spontaneous adverse events

**Time Frame:** Throughout the entire study period (Day 0-42)

**Measure:** Immune response in terms of number of seroconverted subjects

**Time Frame:** Before (Day 0) and after (Day 21) vaccination

**Measure:** Immune response in terms of number of seroprotected subjects

**Time Frame:** Before (Day 0) and after (Day 21) vaccination

#### Secondary Outcomes

**Description:** Titres calculated as geometric mean

**Measure:** Immunogenicity with respect to components of the study vaccine in terms of number of subjects with titres above the pre-defined cut-off

**Time Frame:** At Day 21 after vaccination

**Measure:** Immune response to components of the study vaccine in terms of mean Geometric increase

**Time Frame:** At Day 21 after vaccination

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female.
* Adults 18-64 years of age, inclusive.
* Satisfactory baseline medical assessment by history, physical examination, and clinical laboratory testing.
* Capable of informed consent.
* Able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

* Acute illness at the time of enrollment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection and/or chronic use of immunosuppressants of other immune-modifying drugs within 6 months of administration of the study vaccine.
* Presence of an unstable chronic illness.
* Complicated diabetes mellitus.
* Active neurological disorder.
* History of any demyelinating disease including Guillain-Barré syndrome.
* Any clinical laboratory abnormality.
* Any disorder of coagulation or treatment with coumadin derivatives or heparin.
* Vital sign abnormalities at screening.
* Acute or chronic liver, renal or inflammatory bowel disease or collagen vascular disease.
* Cancer, or treatment for cancer, within three years.
* History of significant alcohol or drug abuse within one year prior to the screening visit.
* Positive urine drug screen at screening within 3 months prior to the screening visit or hard drugs. Products such as ativan, tylenol with codeine should be stopped sufficiently ahead of the screening visit in order to avoid a positive urine drug screen.
* Positive testing for hepatitis B, hepatitis C or human immunodeficiency virus at screening.
* Receipt of an influenza vaccine within 9 months prior to dosing.
* Planned administration of any other vaccines 30 days before study immunization or during the course of the study. Immunization on an emergency basis, such as Tetanus and Diphtheria Toxoids Adsorbed for adult use, will be allowed provided the vaccine is not administered within two weeks prior to study immunization.
* Use of any investigational or non-registered drug or vaccine or participation in an investigational study within 30 days prior to administration of study vaccine, or planned use during the study period.
* Receipt of any immunoglobulins and/or any blood products within three months of screening or planned administration of any of these products during the study period.
* Receipt of a depot injection or an implant of any drug within 3 months prior to administration of study vaccine.
* Any known or suspected allergy to any constituent of Fluviral™ S/F or Fluzone®.
* A history of severe adverse reaction to a previous dose of any influenza vaccine.
* History of anaphylactic type reactions to consumption of eggs.
* Any other condition or social circumstance that, in the opinion of the Principal Investigator, would make the subject unsuitable for or unable to complete the study.
* Breast-feeding subject.
* Positive urine pregnancy test at screening.
* Female subjects having sexual intercourse with any non-sterile male partner within 14 days prior to vaccine administration and without a history of acceptable contraception.

**Healthy Volunteers:** True

**Maximum Age:** 64 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** GlaxoSmithKline

**Name:** GSK Clinical Trials

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009976

- Term: Orthomyxoviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: HIGH

- As Found: Influenza

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12902

- Name: Orthomyxoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007251

- Term: Influenza, Human

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
