Clinical trial NCT00363077: Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza vaccine
Prophylaxis Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Days 0 and 21
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Day 0 and Day 21
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
Secondary outcomes:
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
timeFrame: At Days 0 and 21
measure: Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
timeFrame: At Days 0 and 21
measure: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
timeFrame: During the 30-day (Days 0-29) post vaccination period
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs).
timeFrame: During the entire study period (from Day 0 to Day 29)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: