Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

Influenza Clinical Trial

Official title:

A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363077
• Other study ID #: 107975
• Status: Completed
• Phase: Phase 2
• Start date: October 2, 2006
• Est. completion date: November 17, 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 17, 2006
• Est. primary completion date: November 1, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.

• A male or female 60 years or older at the time of the first vaccination.

• Free of obvious health problems

Exclusion Criteria:

• Use of non-registered products

• Administration of immune-modifying drugs.

• Administration of vaccine 30 days before enrolment in study.

• Immunosuppressive or immunodeficient condition.

• Hypersensitivity to a previous dose of influenza vaccine

• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.

• History of confirmed influenza infection within the last 12 Months.

• Acute disease at the time of enrolment/vaccination.

• History of allergy or reactions likely to be exacerbated by any component of the vaccine

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• GSK1247446A Group
Low dose influenza vaccine adjuvanted with AS03 compared
• Fluarix™
GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Gent

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.	Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.	At Days 0 and 21
Primary	Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer =1:40 or a pre-vaccination titer =1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.	At Day 21
Primary	Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.	A seroprotected subject was defined as a vaccinated subject who had a serum HI titer = 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.	At Day 0 and Day 21
Primary	Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.	The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.	At Day 21
Secondary	Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.	The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-a).	At Days 0 and 21
Secondary	Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.	The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-a).	At Days 0 and 21
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.	Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.	During the 7-day (Days 0-6) post-vaccination period
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.	Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (=) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.	During the 7-day (Days 0-6) post-vaccination period
Secondary	Number of Subjects With 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 unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.	During the 30-day (Days 0-29) post vaccination period
Secondary	Number of Subjects With 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. Related = SAE considered by the investigator to have a causal relationship to study vaccination.	During the entire study period (from Day 0 to Day 29)

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