Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

NCT00529516 | Completed Phase 3 Results

• 1 other identifier: 109821
• Study Type: interventional
• Target: 1,252
• Locations: 4 countries
• Sites: 29

Brief Summary

Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.

Conditions

Influenza

Keywords

Fluarix; GSK Bio's influenza vaccine GSK576389A; Influenza infection

Outcome Measures

Primary Outcomes (5)

• Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

  Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.

  During a 7-day follow-up period after vaccination

• Duration of Solicited Local Adverse Events

  Duration was expressed as the median number of days the symptom was experienced.

  During a 7-day follow-up period after vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)

  Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.

  During a 7-day follow-up period after vaccination

• Duration of Solicited General Adverse Events

  Duration was expressed as the median number of days the symptom was experienced.

  During a 7-day follow-up period after vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

  Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.

  During a 21-day follow-up period after vaccination

Secondary Outcomes (16)

• Number of Subjects With Any and Related Serious Adverse Events (SAEs)

  During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)

• Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)

  During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)

• Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains

  At Days 0 and 21

• Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains

  At Day 21

• Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains

  At Day 21

Study Arms (3)

FluAS25 Group

EXPERIMENTAL

Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.

Biological: GSK Biologicals Influenza Vaccine GSK576389A

Fluarix ≥ 65 years age Group

ACTIVE COMPARATOR

Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Biological: Fluarix

Fluarix 18-40 years age Group

ACTIVE COMPARATOR

Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.

Biological: Fluarix

Interventions

GSK Biologicals Influenza Vaccine GSK576389A BIOLOGICAL

Single dose, Intramuscular injection

FluAS25 Group

Fluarix BIOLOGICAL

Single dose, Intramuscular injection

Fluarix 18-40 years age Group; Fluarix ≥ 65 years age Group

Eligibility Criteria

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

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.
• Written informed consent obtained from the subject.
• Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
• 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 2 months after completion of the vaccination series.
• Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the \>= 65 years age group or in the 18-40 years age group .

You may not qualify if:

• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
• Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination
• Planned administration of an influenza vaccine other than the study vaccines during the entire study period
• Any vaccination against influenza since January 2007
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of hypersensitivity to a previous dose of influenza vaccine
• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests
• Acute disease at the time of enrolment
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period
• Any medical conditions in which IM injections are contraindicated
• Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (29)

GSK Investigational Site

Clearwater, Florida, 33761, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33134, United States

Location

GSK Investigational Site

Milford, Massachusetts, 01757, United States

Location

GSK Investigational Site

Chaska, Minnesota, 55318, United States

Location

GSK Investigational Site

Somers Point, New Jersey, 08244, United States

Location

GSK Investigational Site

Poughkeepsie, New York, 12601, United States

Location

GSK Investigational Site

Carnegie, Pennsylvania, 15106, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16506, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15236, United States

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Messkirch, Baden-Wurttemberg, 88605, Germany

Location

GSK Investigational Site

Augsburg, Bavaria, 86150, Germany

Location

GSK Investigational Site

Haag, Bavaria, 83527, Germany

Location

GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany

Location

GSK Investigational Site

Langquaid, Bavaria, 84085, Germany

Location

GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04129, Germany

Location

GSK Investigational Site

Berlin, 10365, Germany

Location

GSK Investigational Site

Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, 12687, Germany

Location

GSK Investigational Site

Berlin, 13086, Germany

Location

GSK Investigational Site

Berlin, 13507, Germany

Location

GSK Investigational Site

Bekkestua, 1319, Norway

Location

GSK Investigational Site

Bergen, 5094, Norway

Location

GSK Investigational Site

Elverum, 2408, Norway

Location

GSK Investigational Site

Fredrikstad, N-1601, Norway

Location

GSK Investigational Site

Hamar, 2317, Norway

Location

GSK Investigational Site

Haugesund, 5507, Norway

Location

GSK Investigational Site

Skien, 3717, Norway

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

fluarix

Condition Hierarchy (Ancestors)

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

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 3
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 14, 2007
• Study Start: October 15, 2007
• Primary Completion: December 21, 2007
• Study Completion: June 4, 2008
• Last Updated: June 8, 2018
• Results First Posted: May 30, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9); NO (7); BE (1); DE (12)