Phase 2
Completed N=720
Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
Source: ClinicalTrials.gov NCT00633074 ↗Enrolled (actual)
720
Serious AEs
0.4%
Results posted
May 2012
Primary outcomePrimary: Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains — 6.0; 6.0; 86.5; 93.1 Titer
Summary
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains |
6.0; 6.0; 86.5; 93.1; 15.9; 14.9 | — |
| SECONDARY Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains |
67; 62; 342; 338; 209; 199 | — |
| SECONDARY Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains |
278; 281; 336; 337; 332; 335 | — |
| SECONDARY HI Antibody Seroconversion Factors |
14.3; 15.6; 38.7; 34.8; 21.8; 20.3 | — |
| SECONDARY Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains |
10; 6; 280; 287; 112; 97 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms |
7; 6; 0; 0; 237; 246 | — |
| SECONDARY Duration of Solicited Local Symptoms |
4.0; 3.0; 3.0; 3.0; 3.0; 4.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms |
78; 87; 1; 2; 75; 85 | — |
| SECONDARY Duration of Solicited General Symptoms |
2.0; 2.0; 2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
83; 71; 3; 0; 61; 53 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) |
9; 5; 3; 0; 1; 1 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
3; 0; 0; 0 | — |
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 65 years of age or older at the time of vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion Criteria
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) 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 dose of study vaccine or planned administration during the study period.
- Any medical conditions in which IM injections are contraindicated
Data sourced from ClinicalTrials.gov (NCT00633074). 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. Informational only — not medical advice.