Phase 2
N=437
Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00397215 ↗Enrolled (actual)
437
Serious AEs
11.7%
Results posted
May 2013
Primary outcome: Primary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. — 11.3; 9.7; 10.2; 8.8 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (Biological); Fluarix (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
17.6; 12.3; 18.4; 9.8; 7.0; 5.6 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. |
3.3; 1.6; 5.4; 1.8; 1.3; 1.1 | — |
| PRIMARY Number of Seroprotected Subjects Against 2 Strains of Influenza Disease |
32; 6; 25; 2; 4; 1 | — |
| PRIMARY Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
218.2; 260.9; 97.8; 134.5 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. |
8; 2; 9; 2; 4; 1 | — |
| PRIMARY Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. |
18; 22; 6; 16 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
17.6; 12.3; 18.4; 9.8; 7.0; 5.6 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
17.6; 12.3; 18.4; 9.8; 7.0; 5.6 | — |
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
17.6; 12.3; 18.4; 9.8; 7.0; 5.6 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. |
8; 2; 9; 2; 4; 1 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. |
8; 2; 9; 2; 4; 1 | — |
| PRIMARY Number of Seroconverted Subjects Against 2 Strains of Influenza Disease. |
8; 2; 9; 2; 4; 1 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease. |
3.3; 1.6; 5.4; 1.8; 1.3; 1.1 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
1.5; 1.3; 1.9; 1.4; 1.4; 1.1 | — |
| PRIMARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease |
1.5; 1.3; 1.9; 1.4; 1.4; 1.1 | — |
| PRIMARY Number of Seroprotected Subjects Against 2 Strains of Influenza Disease |
32; 6; 25; 2; 4; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against 2 Strains of Influenza Disease |
32; 6; 25; 2; 4; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against 2 Strains of Influenza Disease |
32; 6; 25; 2; 4; 1 | — |
| PRIMARY Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. |
18; 22; 6; 16 | — |
| PRIMARY Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. |
18; 22; 6; 16 | — |
| PRIMARY Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease. |
18; 22; 6; 16 | — |
| PRIMARY Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
218.2; 260.9; 97.8; 134.5 | — |
| PRIMARY Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
218.2; 260.9; 97.8; 134.5 | — |
| PRIMARY Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. |
218.2; 260.9; 97.8; 134.5 | — |
| SECONDARY Number of Subjects With Adverse Events of Specific Interest (AESIs) |
— | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
1; 0; 5; 1; 10; 0 | — |
| SECONDARY Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. |
148; 55; 141; 47; 13; 5 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
1; 1; 1; 1; 5; 3 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
36; 16; 28; 8; 5; 2 | — |
| SECONDARY Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. |
148; 55; 141; 47; 13; 5 | — |
| SECONDARY Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. |
393.71; 494.27; 495.77; 545.37; 388.69; 461.29 | — |
| SECONDARY Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. |
393.71; 494.27; 495.77; 545.37; 388.69; 461.29 | — |
| SECONDARY Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters. |
148; 55; 141; 47; 13; 5 | — |
| SECONDARY Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells. |
393.71; 494.27; 495.77; 545.37; 388.69; 461.29 | — |
| SECONDARY Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells |
1247.34; 760.03; 1515.07; 850.48; 1188.86; 729.72 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
13; 5; 13; 1; 1; 0 | — |
Summary
The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.
Eligibility Criteria
Inclusion Criteria
- 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 61 years or above at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well controlled underlying disease.
Exclusion Criteria
- Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
- Administration of 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 30 days after the second vaccination with H5N1 vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Data sourced from ClinicalTrials.gov (NCT00397215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.