Last updated: 01/23/2020 12:10:15

Safety study of pandemic candidate influenza vaccines in the elderly population

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GSK study ID
102499
See study documents
Clinicaltrials.gov ID
NCT00306995
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Serum haemagglutination-inhibition (HI) antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 10 post Dose 1

Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 21 post Dose 1

Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2)

Timeframe: At Day 21 post Dose 2 (Day 42)

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)

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 10 post Dose 1

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 21 post Dose 1

Number of seroconverted subjects against influenza A subtype H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

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)

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 10 post Dose 1

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 21 post Dose 1

Seroconversion factor for influenza A subtype H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

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)

Number of seroprotected subjects against H9N2

Timeframe: At Day 10 post Dose 1

Number of seroprotected subjects against H9N2

Timeframe: At Day 21 post Dose 1

Number of seroprotected subjects against H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

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)

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 10 post Dose 1

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 21 post Dose 1

Number of subjects with seroprotection power against H9N2

Timeframe: At Day 21 post Dose 2 (Day 42)

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)

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)

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)

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)

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)

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:

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

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)

Number of subjects with solicited general symptoms

Timeframe: During the 4-days (Day 0-3) post Dose 1

Number of subjects with solicited general symptoms

Timeframe: During the 4-days post Dose 2 (Days 21-24)

Number of subjects with solicited general symptoms

Timeframe: During the 4-Days (Day 0-3) across doses 1 and 2

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)

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 30-days (Day 0-30) post vaccination

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)

Number of subjects with serious adverse events (SAEs)

Timeframe: From Day 0 to Day 51

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 -394 for Subset 2 groups)

Number of subjects with any SAEs

Timeframe: Up to 30-day post Dose 3 (Days 365-394)

Percentage of subjects with antibody persistence

Timeframe: At Days 189 and 365

Frequency of antigen-specific cluster of differentiation 4 (CD4) T-cells

Timeframe: At Days 0, 10, 21 and 42 post vaccination

Frequency of antigen-specific CD4 T-cells

Timeframe: At Days 0, 10, 21 and 42 post-vaccination

Cytokine-positive CD4 T-cells frequency

Timeframe: At Days 10, 21 and 42 post-vaccination

Frequency of antigen-specific cluster of differentiation 8 (CD8) T-cells

Timeframe: At Days 0, 10, 21 and 42 post-vaccination

Frequency of antigen-specific CD8 T-cells

Timeframe: At Days 0, 10, 21 and 42 post-vaccination

Cytokine-positive CD8 T-cells frequency

Timeframe: At Days 0, 10 and 21

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)

Number of subjects with solicited general symptoms

Timeframe: During the 4-days post Dose 2 (Days 21-24)

Number of subjects with solicited general symptoms

Timeframe: During the 4-Days (Day 0-3) across doses 1 and 2

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)

Interventions:
Biological/vaccine: SB218352_15
Biological/vaccine: SB218352_8
Biological/vaccine: SB218352_4
Biological/vaccine: SB218352_2
Biological/vaccine: SB218352_8AL
Biological/vaccine: SB218352_4AL
Biological/vaccine: SB218352_2AL
Enrollment:
385
Observational study model:
Not applicable
Primary completion date:
2006-04-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
May 2005 to July 2006
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
No
  • 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.
  • 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.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Status
Study Complete
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Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
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Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01219
Status
Study Complete
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Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Study Complete
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Location
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Status
Study Complete
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Location
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
Status
Study Complete
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Location
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
Status
Study Complete
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Location
GSK Investigational Site
Ketzin, Brandenburg, Germany, 14669
Status
Study Complete
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Location
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
Status
Study Complete
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Location
GSK Investigational Site
Tostedt, Niedersachsen, Germany, 21255
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2006-04-07
Actual study completion date
2006-04-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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