Clinical trial NCT00306995: Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Official title: A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Influenza Vaccines
Keywords: prophylaxis of pandemic influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 385
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.


Eligibility criteria: Inclusion criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol
* A male or female aged over 60 years at the time of vaccination.
* Written informed consent obtained from the subject.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Participation in an earlier study with a candidate pandemic H9N2 vaccine.
* Acute disease at the time of enrolment.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Drug and/or alcohol dependency.

Primary outcomes:
measure: Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
timeFrame: At Day 10 post Dose 1
measure: Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
timeFrame: At Day 21 post Dose 1
measure: Number of Seroconverted Subjects Against Influenza A Subtype H9N2
timeFrame: At Day 10 post Dose 1
measure: Number of Seroconverted Subjects Against Influenza A Subtype H9N2
timeFrame: At Day 21 post Dose 1
measure: Seroconversion Factor for Influenza A Subtype H9N2
timeFrame: At Day 10 post Dose 1
measure: Seroconversion Factor for Influenza A Subtype H9N2
timeFrame: At Day 21 post Dose 1
measure: Number of Seroprotected Subjects Against H9N2
timeFrame: At Day 10 post Dose 1
measure: Number of Seroprotected Subjects Against H9N2
timeFrame: At Day 21 post Dose 1
measure: Number of Subjects With Seroprotection Power Against H9N2
timeFrame: At Day 10 post Dose 1
measure: Number of Subjects With Seroprotection Power Against H9N2
timeFrame: At Day 21 post Dose 1
measure: Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
timeFrame: At Day 21 post Dose 2 (Day 42)
measure: Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
timeFrame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
measure: Number of Seroconverted Subjects Against Influenza A Subtype H9N2
timeFrame: At Day 21 post Dose 2 (Day 42)
measure: Number of Seroconverted Subjects Against Influenza A Subtype H9N2
timeFrame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
measure: Seroconversion Factor for Influenza A Subtype H9N2
timeFrame: At Day 21 post Dose 2 (Day 42)
measure: Seroconversion Factor for Influenza A Subtype H9N2
timeFrame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
measure: Number of Seroprotected Subjects Against H9N2
timeFrame: At Day 21 post Dose 2 (Day 42)
measure: Number of Seroprotected Subjects Against H9N2
timeFrame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
measure: Number of Subjects With Seroprotection Power Against H9N2
timeFrame: At Day 21 post Dose 2 (Day 42)
measure: Number of Subjects With Seroprotection Power Against H9N2
timeFrame: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)
Secondary outcomes:
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 30-days (Day 0-30) post vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Day 51
measure: Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
timeFrame: At Days 0, 10, 21 and 42 post vaccination
measure: Frequency of Antigen-specific CD4 T-cells
timeFrame: At Days 0, 10, 21 and 42 post-vaccination
measure: Cytokine-positive CD4 T-cells Frequency
timeFrame: At Days 10, 21 and 42 post-vaccination
measure: Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
timeFrame: At Days 0, 10, 21 and 42 post-vaccination
measure: Frequency of Antigen-specific CD8 T-cells
timeFrame: At Days 0, 10, 21 and 42 post-vaccination
measure: Cytokine-positive CD8 T-cells Frequency
timeFrame: At Days 10, 21 and 42 post-vaccination
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-days (Day 0-3) post Dose 1
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-days post Dose 2 (Days 21-24)
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-Days (Day 0-3) across doses 1 and 2
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)
measure: Number of Subjects With Unsolicited AEs
timeFrame: During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)
measure: Number of Subjects With SAEs
timeFrame: Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)
measure: Number of Subjects With Any SAEs
timeFrame: Up to 30-day post Dose 3 (Days 365-394)
measure: Number of Subjects With Antibody Persistence
timeFrame: At Days 189 and 365
measure: Seroconversion Factor (SCF) for Influenza A Subtype H9N2.
timeFrame: At Days 189 and 365
Other outcomes:
Locations:
city: Finsterwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Ketzin
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Tostedt
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geringswalde
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Bramstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Elmshorn
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: