Immunogenicity and Safety of GSK Biologicals' FluLaval® TF

NCT00727428 | Completed Phase 1

• 1 other identifier: 112219
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives \& outcome measures of the primary phase/study.

Conditions

Influenza

Keywords

FluLaval® TF; Safety; Immunogenicity; Influenza

Outcome Measures

Primary Outcomes (4)

• Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains

  Days 0 and 21

• Seroconversion Rates (SCR)

  Day 21

• Seroprotection Rates (SPR)

  Days 0 and 21

• Seroconversion Factors (SCF)

  Day 21

Secondary Outcomes (3)

• Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general signs and symptoms

  During the 4-day follow-up period after vaccination.

• Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general signs and symptoms

  During the 21-day follow-up period after vaccination.

• Occurrence, intensity and investigator's assessment of relationship to vaccine of SAEs and medically attended events

  During the entire study period

Study Arms (1)

Group A

EXPERIMENTAL

Biological: FluLaval® TF

Interventions

FluLaval® TF BIOLOGICAL

One IM injection.

Group A

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
• Male and female adults, 18 to 60 years of age.
• Written informed consent obtained from the subject.
• Access to a consistent means of telephone contact, which may be either in the home or at workplace, land line or mobile, but not a pay phone or other multiple-user device.

You may not qualify if:

• Acute disease at the time of enrollment.
• Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:
• Requiring institution of new medical or surgical treatment within 1 month prior to study enrollment, or
• Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or
• Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
• Hospitalization or an event fulfilling the definition of a SAE within 1 month prior to study enrollment.
• Any confirmed or suspected immunosuppressive condition including:
• History of human immunodeficiency virus (HIV) infection,
• Cancer or treatment for cancer, within 3 years of study enrollment.
• History of renal impairment.
• History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
• Complicated insulin-dependent diabetes mellitus.
• Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
• Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
• Receipt of systemic glucocorticoidswithin 1 month of study enrollment, or chronic use of any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Links

• Results for study 112219 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 4, 2008
• Study Start: August 5, 2008
• Primary Completion: August 29, 2008
• Study Completion: February 17, 2009
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

BE (1)