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

NCT00538213 | Completed Phase 2 Results

• 1 other identifier: 110263
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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 study, the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104887 are eligible for participation in this study.

Conditions

Influenza

Keywords

Influenza vaccine GSK576389A; Fluarix; Influenza infection

Outcome Measures

Primary Outcomes (7)

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

  Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. \>100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.

  Day 0-6

• Duration of Solicited Local AEs

  Duration was defined as number of days with any grade of local symptoms.

  Day 0-6

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

  Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.

  Day 0-6

• Duration of Solicited General AEs

  Duration was defined as number of days with any grade of general symptoms.

  Day 0-6

• Number of Subjects Reporting Any, Grade 3 and Related Unsolicited 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.

  Day 0-20

• Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)

  MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.

  Day 0-20

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

  SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.

  Day 0-20

Secondary Outcomes (7)

• Haemagglutination Inhibition (HI) Antibody Titers

  At Days 0 and 21

• The Number of Subjects Seropositive to HI Antibodies

  At Days 0 and 21

• The Number of Subjects Seroconverted to HI Antibodies

  At Day 21

• HI Antibody Seroconversion Factors (SCF)

  At Day 21

• The Number of Subjects Seroprotected to HI Antibodies

  At Days 0 and 21

Study Arms (3)

Adjuvanted influenza vaccine GSK576389A Group

EXPERIMENTAL

Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.

Biological: GSK Bio's Influenza Vaccine GSK576389A

Fluarix young Group

ACTIVE COMPARATOR

Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.

Biological: Fluarix™

Fluarix elderly Group

ACTIVE COMPARATOR

Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.

Biological: Fluarix™

Interventions

Fluarix™ BIOLOGICAL

Single dose, Intramuscular injection

Fluarix elderly Group; Fluarix young Group

GSK Bio's Influenza Vaccine GSK576389A BIOLOGICAL

Single dose, Intramuscular injection

Adjuvanted influenza vaccine GSK576389A Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A investigational vaccines in the 104887 study (NCT00386698).
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female aged between 19 and 42 years or 66 years and older at the time of the vaccination.
• 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.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period.
• 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 21 days after vaccination.
• Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
• Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
• History of confirmed influenza infection since the date of previous vaccination.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• 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 clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature \<37.5°C / Oral temperature of \<37.5°C).
• Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
• Any medical conditions in which intramuscular injections are contraindicated.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: October 15, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 28, 2007
• Last Updated: June 8, 2018
• Results First Posted: September 5, 2012

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)