Phase 2
N=1,594
Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00532298 ↗Enrolled (actual)
1,594
Serious AEs
0.3%
Results posted
May 2012
Primary outcome: Primary: Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain — 37.9; 40.1; NA; NA titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] (Biological); GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] (Biological); Fluarix [NH 2006/07 season] (Biological); Fluarix [NH 2007/08 season] (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain |
37.9; 40.1; NA; NA; 130.8; 138.5 | — |
| SECONDARY HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations |
37.9; 40.1; 35.3; NA; NA; NA | — |
| SECONDARY The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations |
104; 95; 78; NA; NA; NA | — |
| SECONDARY HI Antibody Seroconversion Factors |
3.5; 3.5; 3.3; NA; NA; NA | — |
| SECONDARY The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations |
160; 163; 156; NA; NA; NA | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
4; 4; 6; 7; 7; 10 | — |
| SECONDARY Duration of Solicited Local AEs |
3.0; 4.0; 6.0; 6.0; 3.0; 6.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs |
58; 36; 19; 39; 30; 20 | — |
| SECONDARY Duration of Solicited General AEs |
2.0; 1.5; 2.0; 2.0; 2.0; 3.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs |
43; 39; 36; 45; 53; 29 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) |
7; 4; 11; 5; 11; 9 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
2; 0; 0; 2; 0; 1 | — |
Summary
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- Administration of other 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 Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the 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 hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular injections are contraindicated.
Data sourced from ClinicalTrials.gov (NCT00532298). 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.