A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk

NCT00586469 | Completed Phase 4 Results

• 1 other identifier: 111258
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 8

Brief Summary

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 World Health Organization (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. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year. Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.

Conditions

Influenza Vaccines

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) of Anti-H3 and B Strains

  GMTs for H1 strain is addressed as a secondary endpoint

  At Day 21

Secondary Outcomes (9)

• Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains

  At Days 0 and 21

• Number of Participants Who Seroconverted.

  At Day 21.

• Number of Seroprotected Participants.

  At Days 0 and 21

• Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1

  At Day 21 compared to Day 0

• The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B

  At Day 21 compared to Day 0

Study Arms (2)

Old Bulk

EXPERIMENTAL

This group receives a full dose of Fluviral made from aged bulk material

Biological: Fluviral

New Bulk

ACTIVE COMPARATOR

This group receives a full dose of Fluviral made from new material

Biological: Fluviral

Interventions

Fluviral BIOLOGICAL

One dose, Intramuscular injection

New Bulk; Old Bulk

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
• Male and female adults, 18 to 60 years.
• Written informed consent obtained from the subject.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.

You may not qualify if:

• Acute disease at the time of enrollment.
• Any confirmed or suspected immunosuppressive condition
• Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• A history of any demyelinating disease including Guillain-Barré syndrome.
• Presence of an active neurological disorder.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
• Receipt of an influenza vaccine within 6 months prior to study enrollment.
• Administration of any vaccines within 30 days prior to study enrollment or during the study period.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
• A history of severe adverse reaction to a previous influenza vaccination.
• Lactating/nursing female.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

Location

GSK Investigational Site

Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

Location

GSK Investigational Site

Toronto, Ontario, M1L 4S4, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Gatineau, Quebec, J8Y 6S8, Canada

Location

GSK Investigational Site

Québec, Quebec, G1W 4R4, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 4J6, Canada

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: December 14, 2007
• Primary Completion: January 14, 2008
• Study Completion: January 14, 2008
• Last Updated: June 27, 2019
• Results First Posted: May 28, 2009

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (8)