Phase 3
Completed N=1,252
Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Source: ClinicalTrials.gov NCT00529516 ↗Enrolled (actual)
1,252
Serious AEs
4.3%
Results posted
May 2012
Primary outcomePrimary: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) — 7; 7; 2; 0 Subjects
Summary
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
7; 7; 2; 0; 0; 0 | — |
| PRIMARY Duration of Solicited Local Adverse Events |
3.0; 2.0; 4.5; 2.0; 2.0; 2.0 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) |
80; 34; 23; 2; 0; 1 | — |
| PRIMARY Duration of Solicited General Adverse Events |
2.0; 3.0; 2.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
82; 68; 62; 7; 5; 5 | — |
| SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
2; 3; 1; 1; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) |
22; 25; 11; 3; 3; 2 | — |
| SECONDARY Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains |
10.5; 10.8; 48.9; 103.5; 53.7; 143.4 | — |
| SECONDARY Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains |
320; 238; 94; 226; 156; 66 | — |
| SECONDARY Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains |
9.8; 5.0; 2.9; 3.9; 2.7; 2.2 | — |
| SECONDARY Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains |
71; 73; 164; 381; 306; 255 | — |
| SECONDARY Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers |
830.72; 674.91; 1276.25; 2013.28; 1010.22; 1607.66 | — |
| SECONDARY Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker |
822.37; 660.01; 1260.65; 1961.18; 981.82; 1556.00 | — |
| SECONDARY Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker |
513.25; 371.64; 753.45; 1081.11; 574.28; 870.84 | — |
| SECONDARY Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker |
769.96; 634.57; 1030.23; 1644.34; 856.60; 1288.54 | — |
| SECONDARY Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker |
586.39; 409.05; 746.02; 1189.34; 608.51; 921.15 | — |
| SECONDARY Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers |
8.25; 6.82; 3.56; 16.75; 6.51; 3.48 | — |
| SECONDARY Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker |
6.19; 4.33; 2.12; 8.09; 5.79; 3.64 | — |
| SECONDARY Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker |
2.77; 2.64; 1.58; 3.09; 2.82; 2.17 | — |
| SECONDARY Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker |
6.82; 8.43; 3.21; 12.70; 5.64; 3.20 | — |
| SECONDARY Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker |
3.05; 2.48; 3.13; 5.67; 3.54; 2.73 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- 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.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
- Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the >= 65 years age group or in the 18-40 years age group .
Exclusion Criteria
- 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 30 days after vaccination
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period
- Any vaccination against influenza since January 2007
- Chronic administration (defined as more than 14 days) 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 (no laboratory testing required).
- 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)
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by 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
- 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
- Any medical conditions in which IM injections are contraindicated
- Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions.
Data sourced from ClinicalTrials.gov (NCT00529516). 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.