Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

NCT00380211 | Completed Phase 3

• 1 other identifier: IDB-200-001
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

Conditions

Influenza

Keywords

Thimerosal reduced content; Immunogenicity, safety, reactogenicity; Young and elderly adults; Influenza vaccine

Outcome Measures

Primary Outcomes (2)

• 21 days after vaccination: seroconversion rate, seroprotection rate,

• geometric mean titer fold increase

Secondary Outcomes (2)

• Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;

• SAEs over the whole study period

Interventions

Influenza vaccine (A/H3N2, A/H1N1, and B strains) BIOLOGICAL

Fluarix BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults (≥18 yrs)
• Stable health status
• Provide informed consent
• Access to direct phone service (NOT a pay phone or a common-use phone service)
• Eligible females must have a negative pregnancy test

You may not qualify if:

• Febrile illness (\>38.0°C oral temperature)
• High blood pressure (≥140/90 mmHg)
• Significant acute or chronic
• Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
• Immunosuppressive condition (confirmed or suspected)
• Renal impairment
• Hepatic dysfunction
• Complicated insulin-dependent diabetes mellitus
• Unstable cardiopulmonary disease
• Blood dyscrasias
• Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
• History of demyelinating disease
• Active neurological disorder
• Significant alcohol or drug abuse
• Significant coagulation disorder (prophylactic antiplatelet medications allowed)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Binghamton, New York, 13901, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

Burke, Virginia, 22015, United States

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; fluarix

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 25, 2006
• Study Start: September 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (6)