A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine
![]() |
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: NCT00505453 |
Recruitment Status
:
Completed
First Posted
: July 23, 2007
Last Update Posted
: November 4, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season.
This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Fluviral® | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over |
Study Start Date : | July 2007 |
Actual Study Completion Date : | August 2007 |

- To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older [ Time Frame: 21 days after vaccination ]
- Evaluate safety & reactogenicity: Solicited AEs [ Time Frame: 4 days ]
- Evaluate safety & reactogenicity: Unsolicited AEs [ Time Frame: 21 days ]
- Evaluate safety & reactogenicity: SAEs [ Time Frame: entire study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male and female adults, 18 years of age and older.
- Female subject of non-childbearing potential. Written informed consent obtained from subject.
Exclusion Criteria:
- Acute disease at the time of enrollment.
- Blood pressure abnormalities.
- Any immunosuppressive condition, such as HIV or cancer.
- Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus.
- Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
- Any demyelinating disease, including Guillain-Barré syndrome.
- Alcohol consumption and/or drug abuse.
- Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment.
- Any known or suspected allergy to the Fluviral vaccine.

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): NCT00505453
Canada, Quebec | |
GSK Investigational Site | |
Sherbrooke, Quebec, Canada, J1H 1Z1 | |
Canada | |
GSK Investigational Site | |
Quebec, Canada, G1W 4R4 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00505453 History of Changes |
Other Study ID Numbers: |
110502 |
First Posted: | July 23, 2007 Key Record Dates |
Last Update Posted: | November 4, 2016 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Keywords provided by GlaxoSmithKline:
Influenza |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |